National Cancer Institute (NCI)

  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:e91396612b5350f988c13041f910c184' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>RATIONALE: Drugs used in chemotherapy, such as pentamidine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well pentamidine works in treating patients with relapsed or refractory melanoma.</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:e91396612b5350f988c13041f910c184' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Wild-type p53 and S100B status at baseline [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:b8be3a05f1f67b84b680e55102c4c56f' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Pre- and post-treatment changes in the concentration of S100B and p21 in tumor biopsy samples [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:83b9bcd33c4cd0c6dcf6cef0fc0842fa' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Serial levels of serum S100B [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:d984f2f5fa053945383a5fbc2801d15e' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:d671c83d5d09cce284b6cd4179fb96ea' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle formulation given together with carboplatin works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:d671c83d5d09cce284b6cd4179fb96ea' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:689ff1ed51caa410865bfbe05cb6f039' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Phase II Trial of Abraxane Plus Carboplatin for Advanced NSCLC for Patients at Risk of Bleeding From VEGF Directed Therapies</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:689ff1ed51caa410865bfbe05cb6f039' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:e2963d622ef251d4ea228ac6d1183018' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>OBJECTIVES: Primary\n<ul>\n<li>To determine the response rate, in terms of overall response rate (complete response and partial response), of paclitaxel albumin-stabilized nanoparticle formulation and carboplatin in patients with stage IIIB-IV or recurrent non-small cell lung cancer who are ineligible for treatment with bevacizumab.</li>\n</ul>\n</p><p> Secondary\n<ul>\n<li>To evaluate safety of this regimen in these patients.</li>\n<li>To describe the overall survival of these patients.</li>\n<li>To describe progression-free survival of these patients.</li>\n</ul>\n</p><p> Tertiary Objectives\n<ul>\n<li>To explore, in a pilot fashion, the activity of this regimen using predictive biomarkers including serum SPARC levels, methylation of SPARC in primary tumor samples and serum, Ras mutations, ERCC1 and SPARC immunohistochemistry, and serum miRNA expression profiles.</li>\n</ul>\n</p><p> OUTLINE: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Paraffin-embedded tissue blocks or unstained slides and blood samples are collected for correlative studies. Samples are analyzed for serum SPARC by ELISA, Ras mutations, ERCC1 AND SPARC by immunohistochemistry, and serum miRNA expression profiling. After completion of study treatment, patients are followed periodically.</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:e2963d622ef251d4ea228ac6d1183018' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:fa3e108138ade7faf010cefc121d7afb' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>DISEASE CHARACTERISTICS:\n<ul>\n<li>Histologically or cytologically confirmed advanced non-small cell lung cancer (NSCLC) meeting 1 of the following criteria:\n<ul>\n<li>Stage IIIB disease with malignant pleural effusion</li>\n<li>Stage IV disease</li>\n<li>Recurrent disease</li>\n</ul>\n</li>\n<li>Squamous cell histology allowed</li>\n<li>Not eligible for curative treatment or treatment with bevacizumab</li>\n<li>Measurable disease according to RECIST</li>\n<li>Tumor (paraffin blocks or slides) must be available for correlative biomarker studies</li>\n<li>No uncontrolled brain metastases (or leptomeningeal disease)\n<ul>\n<li>Controlled brain metastases allowed\n<ul>\n<li>Able to receive appropriate therapeutic radiotherapy</li>\n<li>Able to taper off all steroids without symptoms suggestive of increased intracranial pressure (nausea, vomiting, focal neurologic symptoms) for at least 7 days</li>\n</ul>\n</li>\n</ul>\n</li>\n</ul>\n</p><p> PATIENT CHARACTERISTICS:\n<ul>\n<li>ECOG performance status 0-2</li>\n<li>ANC &#8805; 1.5 x 10^9/L</li>\n<li>Platelets &#8805; 100 x 10^9/L</li>\n<li>Hemoglobin &#8805; 9.0 g/L</li>\n<li>Total bilirubin &#8804; 1.5 mg/dL</li>\n<li>AST and ALT &lt; 2.5 times upper limit of normal</li>\n<li>Creatinine &#8804; 1.5 mg/dL OR creatinine clearance &gt; 50 mg/mL</li>\n<li>No known HIV or hepatitis B or C</li>\n<li>Not pregnant</li>\n<li>Negative pregnancy test</li>\n<li>Thrombotic or embolic event within the past 6 months allowed, provided adequately controlled with therapeutic anticoagulation</li>\n<li>Hemoptysis allowed, provided it is not life threatening or requires palliative procedures (e.g., endobronchial therapy or radiotherapy)</li>\n<li>No cardiac disease, including any of the following:\n<ul>\n<li>NYHA class III-IV congestive heart failure</li>\n<li>Unstable angina (angina symptoms at rest)</li>\n<li>New onset angina (began within the past 3 months)</li>\n<li>Myocardial infarction within the past 6 months</li>\n</ul>\n</li>\n<li>No uncontrolled hypertension, defined as systolic blood pressure (BP) &gt; 150 mm Hg or diastolic BP &gt; 90 mm Hg despite optimal medical management</li>\n<li>No peripheral neuropathy &#8805; grade 2</li>\n<li>No active clinically serious infection &gt; CTCAE grade 2</li>\n<li>No serious non-healing wound, ulcer, or bone fracture</li>\n<li>No significant traumatic injury within the past 4 weeks</li>\n<li>No evidence or history of bleeding diathesis or coagulopathy</li>\n<li>No prior malignancy, except for adequately treated basal cell skin cancer, carcinoma in situ of the cervix, or other cancer for which the patient has been disease-free for 2 years\n<ul>\n<li>Stage I (T1c) prostate cancer adequately treated 2 years prior to diagnosis of NSCLC allowed, however metastatic prostate cancer currently receiving hormonal therapy or chemotherapy is not allowed</li>\n</ul>\n</li>\n<li>No significant psychiatric illness, in the opinion of the principal investigator, that would prevent adequate informed consent or render therapy unsafe</li>\n</ul>\n</p><p> PRIOR CONCURRENT THERAPY:\n<ul>\n<li>See Disease Characteristics</li>\n<li>Concurrent therapeutic anticoagulation, &gt; 325 mg acetylsalicylic acid, or chronic non-steroid anti-inflammatory drug use allowed</li>\n<li>At least 14 days since prior and no concurrent radiotherapy</li>\n<li>More than 4 weeks since prior major surgery or open biopsy</li>\n</ul>\n</p>', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:fa3e108138ade7faf010cefc121d7afb' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:a9cf1b60cee59581ac836c2a5fd32de1' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Overall survival [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:a9cf1b60cee59581ac836c2a5fd32de1' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Progression-free survival [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:0e79568ecdbbf006d075c1c708fed460' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:95d610805ed30d6eb4b1ca834e7228f6' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>RATIONALE: Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of endometrial cancer cells. Hormone therapy using megestrol and tamoxifen may fight endometrial cancer by blocking the use of estrogen by the tumor cells. It is not yet known whether temsirolimus is more effective when given alone or together with megestrol and tamoxifen in treating endometrial cancer. PURPOSE: This randomized phase II trial is studying temsirolimus to see how well it works with or without megestrol and tamoxifen in treating patients with advanced, persistent, or recurrent endometrial cancer.</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:95d610805ed30d6eb4b1ca834e7228f6' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:0e79568ecdbbf006d075c1c708fed460' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Progression-free survival [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:0e79568ecdbbf006d075c1c708fed460' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Survival time [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:4e56d88a3beb7f0f7bdec4c92605a2e1' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Frequency of complete and partial clinical response [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:ff62f066563d4afd0c677140dda982f6' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Number of patients remaining on study therapy at 24 weeks [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:414beed64dc99d8ba8dbe8804f38a9db' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>RATIONALE: Aflibercept may stop the growth of tumor cells by blocking blood flow to the tumor and by carrying tumor-killing substances directly to thyroid cancer cells. PURPOSE: This phase II trial is studying how well aflibercept works in treating patients with recurrent and/or metastatic thyroid cancer that has not responded to radioactive iodine therapy.</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:ff4298748f037e3a01fd6a941b24e6cc' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>A Phase II Study of Single Agent Intravenous (IV) in Patients With Poor Prognostic Recurrent and/or Metastatic Thyroid Cancer After RAI Therapy</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:1d5f407716cd1095cce70c1112e76d1a' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:0eeddc6b425c97aa0650d3a509673bd5' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>OBJECTIVES: Primary\n<ul>\n<li>To determine the radiographic response rate, per RECIST criteria, in patients with recurrent and/or metastatic, radioactive iodine-refractory, differentiated thyroid carcinoma of follicular cell origin after completion of 8 weeks of intravenous aflibercept therapy.</li>\n<li>To determine the 6-month progression-free survival rate in patients treated with this drug.</li>\n</ul>\n</p><p> Secondary\n<ul>\n<li>To determine the safety and toxicity profile of this drug in these patients.</li>\n<li>To determine the biologic effect of this drug on fludeoxyglucose F 18 (FDG) avidity after 8 weeks of therapy in these patients using pre- and post-treatment FDG-PET scans.</li>\n<li>To correlate thyroglobulin concentration with radiographic response at 8 weeks and progression-free survival at 6 months in patients treated with this drug.</li>\n<li>To correlate pre-treatment serum VEGF concentration with clinical outcomes after therapy in these patients.</li>\n</ul>\n</p><p> Tertiary\n<ul>\n<li>To determine the population pharmacokinetics of this drug in these patients.</li>\n<li>To determine whether antibodies to this drug develop in these patients.</li>\n</ul>\n</p><p> OUTLINE: Patients receive aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients experiencing clear clinical benefit with aflibercept may continue treatment beyond 12 months, at the discretion of the study sponsor. Patients undergo fludeoxyglucose F 18 (FDG)-PET scans at baseline and after 8 weeks of study therapy to evaluate changes in FDG avidity on FDG-PET scan. Blood samples are obtained at baseline and periodically during study for laboratory correlative studies. Samples are examined for pretreatment serum VEGF concentration, thyroglobulin levels (when elevated) after 8 weeks of therapy, serum pharmacokinetics of aflibercept by ELISA, and anti-aflibercept antibodies. After completion of study therapy, patients are followed for up to 3 months.</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:0eeddc6b425c97aa0650d3a509673bd5' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:d9383b9e55a51c8355f5c9212663f319' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>DISEASE CHARACTERISTICS:\n<ul>\n<li>Histopathologically confirmed differentiated thyroid carcinoma of follicular cell origin, including any of the following histologies and their respective variants:\n<ul>\n<li>Papillary</li>\n<li>Follicular</li>\n<li>H&#252;rthle cell</li>\n</ul>\n</li>\n<li>Must have surgically inoperable and/or recurrent or metastatic disease</li>\n<li>At least one fludeoxyglucose F 18 (FDG)-PET-avid lesion, defined as any focus of increased FDG uptake &gt; normal mediastinal activity with standard uptake variable (SUV) maximum levels &#8805; 3, as documented by baseline PET scan</li>\n<li>Measurable disease, defined as &#8805; 1 unidimensionally measurable lesion &#8805; 20 mm by conventional techniques or &#8805; 10 mm by spiral CT scan</li>\n<li>Progressive disease, defined by &#8805; 1 of the following occurring during or after prior treatment (e.g., radioactive isotope [RAI] treatment):\n<ul>\n<li>Presence of new or progressive lesions on CT scan or MRI</li>\n<li>New lesions on bone scan or PET scan</li>\n<li>Rising thyroglobulin level documented by a minimum of 3 consecutive rises, with an interval of &gt; 1 week between each determination</li>\n</ul>\n</li>\n<li>Refractory to RAI, as defined by one of the following:\n<ul>\n<li>Absent or insufficient RAI uptake in either all lesions and/or the index lesion (e.g., dominant mass) as documented by whole body RAI scan &lt; 6 months prior to initiation of therapy on this protocol\n<ul>\n<li>Insufficient uptake will be defined as &quot;faint&quot; or &quot;minimal&quot; based on independent assessment by 2 observers from either endocrinology or nuclear medicine\n<ul>\n<li>In the setting of insufficient uptake, &#8805; 1 evaluable lesion with absent RAI uptake must be present</li>\n</ul>\n</li>\n</ul>\n</li>\n<li>Progression of disease after RAI treatment, as defined above\n<ul>\n<li>RAI treatment must occur within 6 months of repeat imaging and/or thyroglobulin testing</li>\n</ul>\n</li>\n<li>FDG-avid lesions via PET scan</li>\n</ul>\n</li>\n<li>No known history of brain metastasis</li>\n</ul>\n</p><p> PATIENT CHARACTERISTICS:\n<ul>\n<li>ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%</li>\n<li>ANC &#8805; 1,500/mcL</li>\n<li>Platelet count &#8805; 75,000/mcL</li>\n<li>WBC &#8805; 3,000/mcL</li>\n<li>Total bilirubin &#8804; 1.5 times upper limit of normal(ULN)</li>\n<li>AST and ALT &#8804; 2.5 times ULN</li>\n<li>Creatinine &#8804; 1.5 times ULN OR creatinine clearance &#8805; 60 mL/min</li>\n<li>INR &#8804; 1.2 (&#8804; 1.5 times ULN if on prophylactic-dose anticoagulation)</li>\n<li>Urine protein:creatinine ratio &lt; 1 OR 24-hour urine protein &lt; 500 mg</li>\n<li>Not pregnant or nursing</li>\n<li>Negative pregnancy test</li>\n<li>Fertile patients must use effective contraception during and for &#8805; 6 months after completion of study therapy</li>\n<li>Must have documentation of stable blood pressure on 3 separate days prior to the start of treatment, including the reading at the screening visit and two historical readings within the past 3 months</li>\n<li>No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies</li>\n<li>No history of allergic reactions attributed to compounds of similar chemical or biologic composition to other agents used in the study</li>\n<li>No serious or non-healing wound, ulcer, or bone fracture</li>\n<li>No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess in the past 28 days</li>\n<li>No significant traumatic injury within the past 28 days</li>\n<li>No clinically significant cardiovascular disease, defined as any of the following:\n<ul>\n<li>Cerebrovascular accident within the past 6 months</li>\n<li>Uncontrolled hypertension, defined as systolic blood pressure &gt; 180 mm Hg OR diastolic blood pressure &gt; 105 mm Hg on &#8805; 2 repeated determinations on separate days within the past 3 months</li>\n<li>Myocardial infarction within the past 6 months</li>\n<li>Coronary artery bypass grafting or unstable angina within the past 6 months</li>\n<li>NYHA grade III-IV congestive heart failure</li>\n<li>Serious cardiac arrhythmia requiring anti-arrhythmic medication</li>\n<li>Canadian Cardiovascular Class grade III or greater angina within the past 6 months</li>\n<li>Clinically significant peripheral vascular disease within the past 6 months</li>\n<li>Pulmonary embolism, deep-vein thrombosis, or other thromboembolic event within the past 6 months</li>\n<li>Uncontrolled coronary artery disease, angina, congestive heart failure, or ventricular arrhythmia requiring acute medical management</li>\n<li>Myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months</li>\n</ul>\n</li>\n<li>No evidence of bleeding diathesis or coagulopathy</li>\n<li>No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness or social situation that would limit study compliance</li>\n</ul>\n</p><p> PRIOR CONCURRENT THERAPY:\n<ul>\n<li>See Disease Characteristics</li>\n<li>Recovered from prior therapy</li>\n<li>No prior VEGF-targeted antibody therapy (e.g., bevacizumab or aflibercept)</li>\n<li>More than 4 weeks since prior systemic therapy or radiotherapy</li>\n<li>More than 7 days since prior core biopsy</li>\n<li>Up to 1 prior targeted biologic agent (e.g., small-molecule tyrosine kinase inhibitor or histone deacetylase inhibitor) allowed provided treatment was stopped &#8805; 4 weeks prior to initiation of therapy on this study</li>\n<li>Up to 1 prior cytotoxic chemotherapy (e.g., doxorubicin hydrochloride) allowed provided treatment was stopped &#8805; 4 weeks prior to initiation of therapy on this study</li>\n<li>Prior systemic chemotherapy administered as part of initial definitive treatment (e.g., as a radiation sensitizer or as initial adjuvant therapy) allowed provided treatment was stopped &#8805; 3 months prior to initiation of therapy on this study and does not count in the determination of prior targeted or cytotoxic therapy</li>\n<li>At least 4 weeks since prior cyclooxygenase-2 (COX-2) inhibitors, cis-retinoic acid, or complementary medications, even if given with anti-cancer intent\n<ul>\n<li>Medications given for a specific clinical indication (e.g., daily aspirin status post myocardial infarction or COX-2 inhibitors at standard anti-inflammatory/pain doses) may be continued based on the clinical judgment of the involved investigator</li>\n</ul>\n</li>\n<li>Prior RAI therapy allowed provided it was stopped &gt; 3 months prior to initiation of therapy on this protocol and evidence of progression (as defined above) has been documented in the interim\n<ul>\n<li>A diagnostic study using &lt; 10 mCi of RAI is not considered RAI therapy</li>\n</ul>\n</li>\n<li>Prior external-beam radiotherapy to index lesions allowed provided there has been documented progression by RECIST criteria and at least 4 weeks have elapsed\n<ul>\n<li>At least 4 weeks since prior external-beam radiation therapy to non-index lesions</li>\n</ul>\n</li>\n<li>At least 4 weeks since prior surgery</li>\n<li>Concurrent therapeutic-dose anticoagulants (e.g., warfarin) with PT INR &gt; 1.5 allowed provided that both of the following criteria are met:\n<ul>\n<li>In-range INR appropriate to the treatment indication (e.g., between 2 and 3 for atrial fibrillation) AND on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin</li>\n<li>No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)</li>\n</ul>\n</li>\n<li>Patients receiving concurrent antihypertensive agents must have documentation of the date of the last change in dosage</li>\n<li>No other concurrent investigational agents</li>\n<li>No major surgical procedure or open biopsy within the past 28 days</li>\n<li>No anticipation of need for major surgical procedures during the course of the study</li>\n</ul>\n</p>', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:d9383b9e55a51c8355f5c9212663f319' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:1911b8a9e43d11d1377c49510aa0ae00' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Pharmacokinetics [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:1911b8a9e43d11d1377c49510aa0ae00' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Radiographic response rate as assessed by RECIST criteria after completion of 8 weeks of study therapy [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:9c40809e5d66cdc54e1757234b1c4092' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>6-month progression-free survival rate [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:f05044c2336d046d5366f0f6e61b9e3a' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:352be204b71315044ec6db5592cd2a8d' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Safety and toxicity profile, in terms of adverse events, laboratory data, and vital sign data [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;Yes&nbsp;]</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:352be204b71315044ec6db5592cd2a8d' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:28ab42690c856b38dd41caa4b5029fb2' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Biologic effect of aflibercept on fludeoxyglucose F 18 avidity at 8 weeks [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:28ab42690c856b38dd41caa4b5029fb2' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:6895617c887d117c7447587cf9f310b6' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Correlation of thyroglobulin concentration with radiographic response at 8 weeks [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:6895617c887d117c7447587cf9f310b6' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:cd0d9fbfcc69cf66e5fa4ce4e8bb3a19' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Correlation of thyroglobulin concentration with progression-free survival at 6 months [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:cd0d9fbfcc69cf66e5fa4ce4e8bb3a19' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:bfe6a773cae2ff2de6bda0ae315b34f8' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Correlation of pre-treatment serum aflibercept concentration with clinical outcomes after therapy [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:bfe6a773cae2ff2de6bda0ae315b34f8' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:b222303f60d7a9ccc5c52287279984e4' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Development of aflibercept antibodies [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:b222303f60d7a9ccc5c52287279984e4' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:fbaa2af07d07aa612bdda27ed282af11' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>RATIONALE: Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Giving vorinostat together with lenalidomide may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat when given together with lenalidomide after autologous stem cell transplant in treating patients with persistent multiple myeloma.</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:fbaa2af07d07aa612bdda27ed282af11' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:a9cf1b60cee59581ac836c2a5fd32de1' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Overall survival [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:a9cf1b60cee59581ac836c2a5fd32de1' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:0e79568ecdbbf006d075c1c708fed460' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Progression-free survival [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:0e79568ecdbbf006d075c1c708fed460' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:496969d7db91b883af7a8c22a7dad757' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Response rate [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:496969d7db91b883af7a8c22a7dad757' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:64c94527c722c897a14033e356f8eb6b' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Time to progression [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:64c94527c722c897a14033e356f8eb6b' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:ee28679e59cceacccdd3b0ead00a1752' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Duration of response [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:ee28679e59cceacccdd3b0ead00a1752' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:c0f5d251f91a3e5d08743ca8af30a584' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Clinical benefit [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:c0f5d251f91a3e5d08743ca8af30a584' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Time to response [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:f95f6e54a8cba632bcacd53bfc263e38' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:6ab62910245f686d1fa756d57f99d717' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Duration of overall response [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:6ab62910245f686d1fa756d57f99d717' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:a3764588d372ac425fd6ffc809513d50' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>RATIONALE: Drugs used in chemotherapy, such as hydroxychloroquine, carboplatin, and paclitaxel and work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving hydroxychloroquine together with carboplatin, paclitaxel and bevacizumab may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of hydroxychloroquine when given together with carboplatin, paclitaxel, and bevacizumab and to see how well they work in treating patients with recurrent advanced non-small cell lung cancer.</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:a3764588d372ac425fd6ffc809513d50' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:72b217489c5f7536d71be183378fcfc4' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Overall survival (Phase II) [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:72b217489c5f7536d71be183378fcfc4' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Time to progression (Phase II) [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:29660a5a9c85aeab9bbc9f62e4a81284' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Overall response (Phase II) [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:a79f6e38b8ff6f704715711033db33a1' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Recommended phase II dose of hydroxychloroquine and carboplatin when administered with paclitaxel and bevacizumab (phase I) [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:bdd3c8e3a0ccb9e1d657af0499b1d698' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Progression-free survival at 1 year (phase II) [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:7b5402aa6a578260212927beeaa327fb' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:73e17bcc1a94ebd672b913e6684b1727' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>RATIONALE: Palifermin may help relieve or prevent oral mucositis caused by chemotherapy and radiation therapy in young patients undergoing stem cell transplant. PURPOSE: This randomized phase II trial is studying palifermin to see how well it works compared with a placebo in preventing oral mucositis caused by chemotherapy and/or radiation therapy in young patients undergoing stem cell transplant.</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:73e17bcc1a94ebd672b913e6684b1727' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>A Group-Wide Double-Blind Randomized Placebo-Controlled Trial of Palifermin to Prevent Chemotherapy and/or Radiotherapy Induced Oral Mucositis in Children Undergoing Autologous or Allogeneic Hematopoietic Stem Cell Transplantation</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:df5f8ae469adb8470aa30e5df7c98a46' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:a35da0cfa0a7a86f6409af67c4b7bd98' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>OBJECTIVES: Primary\n<ul>\n<li>To compare whether palifermin versus placebo administered to pediatric patients three days prior to conditioning and three days after autologous or allogeneic hematopoietic stem cell transplantation (HSCT) is associated with a reduction in the incidence of WHO grade 3 or 4 oral mucositis.</li>\n</ul>\n</p><p> Secondary\n<ul>\n<li>To evaluate the safety and tolerability of palifermin.</li>\n<li>To evaluate the long-term effects of palifermin on disease outcome and survival.</li>\n<li>To compare the incidence, total dose, and duration of parenteral opioid analgesic use (morphine equivalents), and incidence and duration of total parenteral nutrition (TPN) administration in patients treated with these regimens.</li>\n<li>To compare the incidence of febrile neutropenia and invasive bacterial infections in patients treated with these regimens.</li>\n<li>To determine whether palifermin versus placebo reduces the incidence of WHO grade 3 or 4 oral mucositis among allogeneic HSCT pediatric patients receiving methotrexate as graft-versus-host disease (GVHD) prophylaxis.</li>\n<li>To determine whether palifermin versus placebo reduces acute and chronic GVHD after allogeneic HSCT.</li>\n<li>To describe health care utilization (hospitalization duration, and administration of antibiotics, TPN, nasogastric-, nasojejunal- or gastrostomy-administered enteral nutrition, and blood products) in pediatric patients treated with these regimens.</li>\n</ul>\n</p><p> OUTLINE: This is a multicenter study. Patients are stratified according to age in years (1 to 2 vs 3 to 11 vs 12 to 16), type of hematopoietic stem cell transplantation (HSCT) (autologous vs allogeneic), conditioning regimen (either total-body irradiation [TBI] or melphalan vs neither TBI nor melphalan). Patients are randomized to 1 of 2 treatment arms.\n<ul>\n<li>Arm I: Patients receive palifermin IV once daily for 3 days prior to chemotherapy and/or radiotherapy in the absence of unacceptable toxicity.</li>\n</ul>\n</p><p> Patients then receive palifermin IV on days 0, 1, and 2 after autologous or allogeneic HSCT.\n<ul>\n<li>Arm II: Patients receive placebo IV once daily for 3 days prior to chemotherapy and/or radiotherapy in the absence of unacceptable toxicity. Patients then receive placebo IV on days 0, 1, and 2 after autologous or allogeneic HSCT.</li>\n</ul>\n</p><p> Blood samples are collected at baseline, 32 days, and 100 days after HSCT to evaluate the immunogenicity of palifermin. Oral mucositis is assessed at baseline, daily for 8 days prior to and 32 days after HSCT, or until oral mucositis has resolved by the WHO Mucositis Scale, Oral Mucositis Assessment Scale (OMAS), modified Walsh mucositis scale, Oral Mucositis Daily Questionnaire (OMDQ), and the pain categorical rating scale. After completion of HSCT, patients are followed periodically for up to 10 years.</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:a35da0cfa0a7a86f6409af67c4b7bd98' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:bb95235845e20e6a675762a6d3f40d7e' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>DISEASE CHARACTERISTICS:\n<ul>\n<li>Patients undergoing myeloablative autologous or allogeneic hematopoietic stem cell transplantation (HSCT) for any indication</li>\n<li>Any type of myeloablative HSCT conditioning regimen allowed</li>\n<li>Patients undergoing allogeneic HSCT may undergo 1 of the following types of donor stem cells:\n<ul>\n<li>HLA-matched sibling or parent</li>\n<li>Partially matched family donor (mismatched for a single HLA locus [class I])</li>\n<li>Fully matched unrelated marrow or peripheral blood stem cell donor</li>\n<li>HLA-matched or partially mismatched (at least 4 of 6 match) cord blood (class I or II)</li>\n</ul>\n</li>\n</ul>\n</p><p> PATIENT CHARACTERISTICS:\n<ul>\n<li>Not pregnant or nursing</li>\n<li>Negative pregnancy test</li>\n<li>Fertile patients must use effective contraception</li>\n<li>No HIV positivity</li>\n<li>No known sensitivity to any E. coli-derived products\n<ul>\n<li>Known grade 1 to 2 allergic reactions to asparaginase allowed</li>\n<li>No prior grade 3-4 allergies to asparaginase or pegaspargase</li>\n</ul>\n</li>\n</ul>\n</p><p> PRIOR CONCURRENT THERAPY:\n<ul>\n<li>See Disease Characteristics</li>\n<li>More than 30 days since prior and no concurrent treatment with any of the following therapies:\n<ul>\n<li>Oral cryotherapy</li>\n<li>Glutamine as an oral supplement</li>\n<li>Traumeel&#174;</li>\n<li>Gelclair&#174;</li>\n<li>Oral vancomycin paste</li>\n<li>Low-level laser therapy</li>\n<li>An investigational product or device in another clinical trial</li>\n</ul>\n</li>\n<li>No prior palifermin or other keratinocyte growth factors</li>\n<li>No other concurrent cytotoxic drugs for conditioning or graft-vs-host disease prophylaxis\n<ul>\n<li>Intrathecal methotrexate or cytarabine for CNS involvement allowed</li>\n</ul>\n</li>\n</ul>\n</p>', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:bb95235845e20e6a675762a6d3f40d7e' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:ec6dbdc887d16cd51563c4748d35fa7e' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Safety and tolerability of palifermin [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;Yes&nbsp;]</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:ec6dbdc887d16cd51563c4748d35fa7e' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:8eebff6f10ca6c1fd499b9e8948d715b' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Long-term disease outcome and survival [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:8eebff6f10ca6c1fd499b9e8948d715b' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:0ba2af343f300b31fc7e925de958cb39' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Duration of WHO grade 3 or 4 oral mucositis [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:0ba2af343f300b31fc7e925de958cb39' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:efda079bce71216266982e184ec19e9c' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Incidence, total dose, and duration of parenteral opioid analgesic use (morphine equivalents) [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:efda079bce71216266982e184ec19e9c' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:02fac6ce9cae062f7b8ef9c212258471' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Incidence and duration of total parenteral nutrition administration [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:02fac6ce9cae062f7b8ef9c212258471' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:9e8fe591e820bb46408a222bc02fcaff' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Incidence of febrile neutropenia and invasive bacterial infections [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:9e8fe591e820bb46408a222bc02fcaff' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:a24c53e1e9c2beb430185cc3a2a2a849' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Incidence of WHO grade 3 or 4 oral mucositis among allogeneic HSCT patients receiving methotrexate as GVHD prophylaxis [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:a24c53e1e9c2beb430185cc3a2a2a849' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:4d84bcb8e25523003f9e0c8a53ba6cfa' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Incidence of acute and chronic GVHD after allogeneic HSCT [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:4d84bcb8e25523003f9e0c8a53ba6cfa' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:691942a1d6e9235aa1fe7f2d68315455' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Health care utilization [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:691942a1d6e9235aa1fe7f2d68315455' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:bca30b43085acc1255bde5476a39ad6c' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>RATIONALE: Aerobic exercise may help prevent side effects caused by chemotherapy and help improve heart health. PURPOSE: This randomized clinical trial is studying the side effects of aerobic exercise and to see how well it works in patients receiving chemotherapy for cancer.</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:bca30b43085acc1255bde5476a39ad6c' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:305ec535ae4bfa5b64bd6be840671349' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>CCCWFU 99108 - Effect of Exercise Training in Patients Receiving Anthracycline Drugs - A Pilot Study</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:305ec535ae4bfa5b64bd6be840671349' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:2787adf20983caee44d1ac380b290021' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>OBJECTIVES:\n<ul>\n<li>To determine if patients with cancer can exercise safely and routinely, under supervision, while receiving anthracycline chemotherapy.</li>\n<li>To determine the magnitude of the change in the peak ventilatory oxygen uptake (VO2) before and after completion of anthracycline chemotherapy with concurrent exercise versus without exercise in patients with cancer.</li>\n</ul>\n</p><p> OUTLINE: Patients are randomized to 1 of 2 intervention arms.\n<ul>\n<li>Arm I (exercise): Patients undergo supervised aerobic exercise (walk or bicycle) 3 days a week concurrently with standard anthracycline-based chemotherapy for approximately 18-24 weeks.</li>\n<li>Arm II (non-exercise): Patients receive standard anthracycline-based chemotherapy for approximately 18-24 weeks.</li>\n</ul>\n</p><p> Patients undergo peak ventilatory oxygen uptake (VO_2) by exercise bike test with gas exchange analysis at baseline and at 2 weeks after completion of anthracycline-based chemotherapy.</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:2787adf20983caee44d1ac380b290021' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:55b5ec927ea50e6badcf08f5bf1630ab' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>DISEASE CHARACTERISTICS:\n<ul>\n<li>Patients with cancer scheduled to receive 4-6 courses of an anthracycline-based chemotherapy</li>\n</ul>\n</p><p> PATIENT CHARACTERISTICS:\n<ul>\n<li>Able to pedal a stationary bicycle</li>\n<li>No severe hypertension (systolic blood pressure &gt; 220 mm Hg or diastolic blood pressure &gt;120 mm Hg)</li>\n<li>No atrial fibrillation with an uncontrolled ventricular response</li>\n<li>No ventricular arrhythmias</li>\n<li>No unstable angina</li>\n<li>No acute myocardial infarction within the past 28 days of enrollment</li>\n<li>No severe valvular heart disease</li>\n<li>No severe (exercise-limiting) peripheral vascular disease</li>\n<li>No severe pulmonary disease</li>\n</ul>\n</p><p> PRIOR CONCURRENT THERAPY:\n<ul>\n<li>See Disease Characteristics</li>\n</ul>\n</p>', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:55b5ec927ea50e6badcf08f5bf1630ab' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:b98daa01fb444118f438be1d93efa18d' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Percentage of patients enrolling in the study [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:b98daa01fb444118f438be1d93efa18d' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:e956c142a933fc9c309960797e15c0c7' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Percentage of patients completing the study [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:e956c142a933fc9c309960797e15c0c7' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:2d47e14359d47eefe979a6041fd83956' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Number and types of adverse events [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;Yes&nbsp;]</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:2d47e14359d47eefe979a6041fd83956' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:a2ef6c82166753757ef9cf0cc010f651' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sorafenib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This clinical trial is studying how well sorafenib works in treating patients with locally advanced or metastatic kidney cancer.</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:a2ef6c82166753757ef9cf0cc010f651' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:64c94527c722c897a14033e356f8eb6b' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Time to progression [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:64c94527c722c897a14033e356f8eb6b' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:9e1ec1d14f7df52db2bad391f716c39f' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>MRI apparent diffusion coefficients (ADC) at baseline and week 5 [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:9e1ec1d14f7df52db2bad391f716c39f' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:e55aff79d87d951dc4b41ee41590920d' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Tumor response during the neoadjuvant period [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:e55aff79d87d951dc4b41ee41590920d' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:815d39f41ab40c4fa634fd0ff6b2082b' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Tumor necrotic fraction and pathology determined at surgery [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:815d39f41ab40c4fa634fd0ff6b2082b' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:80e686876a53598acf8af4c4958e54f2' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>RATIONALE: Vaccines made from gene-modified tumor cells may help the body build an effective immune response to kill pancreatic cancer cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving vaccine therapy together with cyclophosphamide may kill more tumor cells. It is not yet known whether vaccine therapy is more effective with or without cyclophosphamide in treating patients with pancreatic cancer. PURPOSE: This randomized clinical trial is studying the side effects of vaccine therapy and to see how well it works when given with or without cyclophosphamide in treating patients undergoing chemotherapy and radiation therapy for stage I or stage II pancreatic cancer that can be removed by surgery.</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:80e686876a53598acf8af4c4958e54f2' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:0f3af95f0f2256f3561808a0835f8619' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>A Randomized Three-Arm Neoadjuvant and Adjuvant Feasibility and Toxicity Study of a GM-CSF Secreting Allogeneic Pancreatic Cancer Vaccine Administered Either Alone or in Combination With Either a Single Intravenous Dose or Daily Metronomic Oral Doses of C</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:0f3af95f0f2256f3561808a0835f8619' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>OBJECTIVES: Primary\n<ul>\n<li>To evaluate the safety and feasibility of a GVAX pancreatic cancer vaccine (GM-CSF gene-transfected allogeneic pancreatic cancer vaccine) when administered alone or in combination with a single intravenous dose or daily metronomic oral doses of cyclophosphamide as neoadjuvant and adjuvant treatment in patients with resectable stage I or II adenocarcinoma of the head, neck, or uncinate process of the pancreas.</li>\n<li>To assess the immune cell infiltrates, particularly T-regulatory cells (Tregs) and CD4+ and CD8+ effector T cells, after neoadjuvant GVAX pancreatic cancer vaccination.</li>\n<li>To assess the changes in the number and function of peripheral mesothelin-specific CD8+ T cells and CD4+, FoxP3+, and GITR+ Tregs after each GVAX pancreatic cancer vaccination when administered alone or in combination with a single dose or metronomic doses of cyclophosphamide.</li>\n</ul>\n</p><p> Secondary\n<ul>\n<li>To estimate disease-free and overall survival of patients treated with these regimens.</li>\n<li>To estimate the effect of immune parameters on disease-free and overall survival of these patients.</li>\n</ul>\n</p><p> OUTLINE: Patients are randomized to 1 of 3 treatment arms.\n<ul>\n<li>Arm I: Patients receive GVAX pancreatic cancer vaccine intradermally (ID) on day 1 and undergo pancreaticoduodenectomy on day 15. Approximately 6-10 weeks after surgery, patients receive an additional dose of the vaccine. Beginning approximately 1 month after vaccination, patients receive standard adjuvant chemoradiotherapy comprising gemcitabine, fluorouracil or capecitabine, and radiotherapy over 26-28 weeks. Beginning approximately 4-8 weeks after the completion of chemoradiotherapy, patients receive the vaccine on day 1. Treatment with the vaccine repeats every 28 days for 4 courses.</li>\n<li>Arm II: Patients receive low-dose cyclophosphamide IV on day 0 and GVAX pancreatic cancer vaccine ID on day 1. Patients undergo pancreaticoduodenectomy on day 15. Approximately 6-10 weeks after surgery, patients receive low-dose cyclophosphamide IV on day 0 and the vaccine on day 1. Beginning approximately 1 month after vaccination, patients receive standard adjuvant chemoradiotherapy comprising gemcitabine, fluorouracil or capecitabine, and radiotherapy over 26-28 weeks. Beginning approximately 4-8 weeks after the completion of chemoradiotherapy, patients receive low-dose cyclophosphamide IV on day 0 and the vaccine on day 1. Treatment with cyclophosphamide and the vaccine repeats every 28 days for 4 courses. </li>\n<li>Arm III: Patients receive GVAX pancreatic cancer vaccine ID on day 1 and low-dose oral cyclophosphamide twice daily on days 1-7. Patients undergo pancreaticoduodenectomy on day 15. Approximately 6-10 weeks after surgery, patients receive the vaccine on day 1 and low-dose oral cyclophosphamide twice daily on days 1-7 and 15-21. Beginning approximately 1 month after vaccination, patients receive standard adjuvant chemoradiotherapy comprising gemcitabine, fluorouracil or capecitabine, and radiotherapy over 26-28 weeks. Beginning approximately 4-8 weeks after the completion of chemoradiotherapy, patients receive the vaccine on day 1 and low-dose oral cyclophosphamide twice daily on days 1-7 and 15-21. Treatment with the vaccine and cyclophosphamide repeats every 28 days for 4 courses. Patients undergo blood sample collection periodically for correlative laboratory studies, including immune cell analysis. Immune cell analysis includes monitoring the quantitative change of peripheral blood lymphocytes, including regulatory T cells (Tregs), and functional analysis of T-cell immune response. Tumor tissue samples collected at the time of surgery are analyzed for tumor antigens and infiltrating immune cells by immunohistochemistry and quantitative real-time PCR.</li>\n</ul>\n</p><p> After completion of study treatment, patients are followed periodically.</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:b2d54bf82a938de37d6ff104d5a649df' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>DISEASE CHARACTERISTICS:\n<ul>\n<li>Newly diagnosed adenocarcinoma of the head, neck, or uncinate process of the pancreas\n<ul>\n<li>Stage I or II disease</li>\n</ul>\n</li>\n<li>Surgically resectable disease (R0 or R1) by spiral CT scan\n<ul>\n<li>No distant metastases</li>\n<li>A clear fat plane is present around the celiac and superior mesenteric arteries</li>\n<li>Patent superior mesenteric and portal veins</li>\n</ul>\n</li>\n<li>Candidate for a pancreaticoduodenectomy</li>\n</ul>\n</p><p> PATIENT CHARACTERISTICS:\n<ul>\n<li>ECOG performance status 0-1</li>\n<li>Hemoglobin &#8805; 9 g/dL</li>\n<li>ANC &#8805; 1,500/mm&#179;</li>\n<li>Platelet count &#8805; 100,000/mm&#179;</li>\n<li>Serum creatinine &#8804; 2 mg/dL</li>\n<li>AST and ALT &#8804; 2 times upper limit of normal (ULN)</li>\n<li>Amylase &#8804; 2 times ULN</li>\n<li>Alkaline phosphatase &#8804; 5 times ULN</li>\n<li>Hyperbilirubinemia secondary to tumor-associated extrahepatic biliary obstruction allowed</li>\n<li>Not pregnant or nursing</li>\n<li>Negative pregnancy test</li>\n<li>Fertile patients must use effective contraception during and for &#8805; 4 weeks after the completion of study treatment</li>\n<li>No history of autoimmune disease, including systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerulonephritis, or vasculitis</li>\n<li>No uncontrolled medical problems</li>\n<li>No active infections</li>\n<li>No other cancer within the past 5 years except for superficial bladder cancer, nonmelanoma skin cancer, or low-grade prostate cancer not requiring therapy</li>\n</ul>\n</p><p> PRIOR CONCURRENT THERAPY:\n<ul>\n<li>More than 28 days since prior anticancer therapy</li>\n<li>No prior cancer immunotherapy, including the same pancreatic cancer vaccine used in this study</li>\n<li>More than 28 days since prior systemic steroid therapy or immunosuppressive therapy</li>\n<li>No systemic steroid therapy or immunosuppressive therapy during and within 28 days after vaccine administration</li>\n<li>No other concurrent immunotherapy, chemotherapy, radiotherapy, gene therapy, biologic therapy, or investigational therapy for the treatment of pancreatic cancer</li>\n</ul>\n</p>', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:4bb90ab4a5fa8458e9af21245eba5d17' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Overall survival [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:a9cf1b60cee59581ac836c2a5fd32de1' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Feasibility [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:f1c396fa3872501ab30e13c6b0f07743' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Immune response [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:b1a118f450c8eb263f4317a6714e856e' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Safety, as measured by local and systemic toxicity according to NCI CTCAE v3.0 [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;Yes&nbsp;]</p>\n', created = 1283570904, expire = 1283657304, headers = '', serialized = 0 WHERE cid = '1:ed8ff7bb29d727b3a409164e93b8c592' in /persistent/html/includes/cache.inc on line 109.

Pentamidine in Treating Patients With Relapsed or Refractory Melanoma

RATIONALE: Drugs used in chemotherapy, such as pentamidine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well pentamidine works in treating patients with relapsed or refractory melanoma.

Background information
Other unique IDs: 
CDR0000602047
MSGCC-0794GCC
MSGCC-H-2987

Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Carboplatin in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer

Trial phase: 
Phase II
Recruitment status: 
Recruiting

RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle formulation given together with carboplatin works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.

Background information
Trial ID: 
NCT00729612
Other unique IDs: 
CDR0000602242
OSU-08059
NCCN-AO8
Official title: 

Phase II Trial of Abraxane Plus Carboplatin for Advanced NSCLC for Patients at Risk of Bleeding From VEGF Directed Therapies

Detailed description: 

OBJECTIVES: Primary

  • To determine the response rate, in terms of overall response rate (complete response and partial response), of paclitaxel albumin-stabilized nanoparticle formulation and carboplatin in patients with stage IIIB-IV or recurrent non-small cell lung cancer who are ineligible for treatment with bevacizumab.

Secondary

  • To evaluate safety of this regimen in these patients.
  • To describe the overall survival of these patients.
  • To describe progression-free survival of these patients.

Number to be enrolled: 
63 patients

Temsirolimus With or Without Megestrol and Tamoxifen in Treating Patients With Advanced, Persistent, or Recurrent Endometrial Cancer

RATIONALE: Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of endometrial cancer cells. Hormone therapy using megestrol and tamoxifen may fight endometrial cancer by blocking the use of estrogen by the tumor cells. It is not yet known whether temsirolimus is more effective when given alone or together with megestrol and tamoxifen in treating endometrial cancer. PURPOSE: This randomized phase II trial is studying temsirolimus to see how well it works with or without megestrol and tamoxifen in treating patients with advanced, persistent, or recurrent endometrial cancer.

Background information
Other unique IDs: 
CDR0000609740
GOG-0248

Aflibercept in Treating Patients With Recurrent and/or Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy

Trial phase: 
Phase II
Recruitment status: 
Recruiting

RATIONALE: Aflibercept may stop the growth of tumor cells by blocking blood flow to the tumor and by carrying tumor-killing substances directly to thyroid cancer cells. PURPOSE: This phase II trial is studying how well aflibercept works in treating patients with recurrent and/or metastatic thyroid cancer that has not responded to radioactive iodine therapy.

Background information
Trial ID: 
NCT00729157
Other unique IDs: 
CDR0000608163
MSKCC-08066
Official title: 

A Phase II Study of Single Agent Intravenous (IV) in Patients With Poor Prognostic Recurrent and/or Metastatic Thyroid Cancer After RAI Therapy

Detailed description: 

OBJECTIVES: Primary

  • To determine the radiographic response rate, per RECIST criteria, in patients with recurrent and/or metastatic, radioactive iodine-refractory, differentiated thyroid carcinoma of follicular cell origin after completion of 8 weeks of intravenous aflibercept therapy.
  • To determine the 6-month progression-free survival rate in patients treated with this drug.

Number to be enrolled: 
41 patients

Vorinostat and Lenalidomide After Autologous Stem Cell Transplant in Treating Patients With Persistent Multiple Myeloma

RATIONALE: Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Giving vorinostat together with lenalidomide may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat when given together with lenalidomide after autologous stem cell transplant in treating patients with persistent multiple myeloma.

Background information
Other unique IDs: 
CDR0000602039
OSU-08001
OSU-2008C0067

Hydroxychloroquine, Carboplatin, Paclitaxel, and Bevacizumab in Treating Patients With Recurrent Advanced Non-Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy, such as hydroxychloroquine, carboplatin, and paclitaxel and work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving hydroxychloroquine together with carboplatin, paclitaxel and bevacizumab may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of hydroxychloroquine when given together with carboplatin, paclitaxel, and bevacizumab and to see how well they work in treating patients with recurrent advanced non-small cell lung cancer.

Background information
Other unique IDs: 
CDR0000600241
CINJ-030801

Palifermin in Preventing Oral Mucositis Caused by Chemotherapy and/or Radiation Therapy in Young Patients Undergoing Stem Cell Transplant

Trial phase: 
Phase II
Recruitment status: 
Not yet recruiting

RATIONALE: Palifermin may help relieve or prevent oral mucositis caused by chemotherapy and radiation therapy in young patients undergoing stem cell transplant. PURPOSE: This randomized phase II trial is studying palifermin to see how well it works compared with a placebo in preventing oral mucositis caused by chemotherapy and/or radiation therapy in young patients undergoing stem cell transplant.

Background information
Trial ID: 
NCT00728585
Other unique IDs: 
CDR0000588622
COG-ACCL0521
Official title: 

A Group-Wide Double-Blind Randomized Placebo-Controlled Trial of Palifermin to Prevent Chemotherapy and/or Radiotherapy Induced Oral Mucositis in Children Undergoing Autologous or Allogeneic Hematopoietic Stem Cell Transplantation

Detailed description: 

OBJECTIVES: Primary

  • To compare whether palifermin versus placebo administered to pediatric patients three days prior to conditioning and three days after autologous or allogeneic hematopoietic stem cell transplantation (HSCT) is associated with a reduction in the incidence of WHO grade 3 or 4 oral mucositis.

Number to be enrolled: 
200 patients

Aerobic Exercise in Patients Receiving Chemotherapy for Cancer

Recruitment status: 
Completed

RATIONALE: Aerobic exercise may help prevent side effects caused by chemotherapy and help improve heart health. PURPOSE: This randomized clinical trial is studying the side effects of aerobic exercise and to see how well it works in patients receiving chemotherapy for cancer.

Background information
Trial ID: 
NCT00728429
Other unique IDs: 
CDR0000601334
CCCWFU-99108
CCCWFU-IRB-IRB00006209
Official title: 

CCCWFU 99108 - Effect of Exercise Training in Patients Receiving Anthracycline Drugs - A Pilot Study

Detailed description: 

OBJECTIVES:

  • To determine if patients with cancer can exercise safely and routinely, under supervision, while receiving anthracycline chemotherapy.
  • To determine the magnitude of the change in the peak ventilatory oxygen uptake (VO2) before and after completion of anthracycline chemotherapy with concurrent exercise versus without exercise in patients with cancer.

Number to be enrolled: 
28 patients

Sorafenib in Treating Patients With Locally Advanced or Metastatic Kidney Cancer

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sorafenib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This clinical trial is studying how well sorafenib works in treating patients with locally advanced or metastatic kidney cancer.

Background information
Other unique IDs: 
CDR0000598555
NU-07U1
BAYER-NU-07U1
NU-IRB-STU00003123

Vaccine Therapy With or Without Cyclophosphamide in Treating Patients Undergoing Chemotherapy and Radiation Therapy for Stage I or Stage II Pancreatic Cancer That Can Be Removed by Surgery

Recruitment status: 
Recruiting

RATIONALE: Vaccines made from gene-modified tumor cells may help the body build an effective immune response to kill pancreatic cancer cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving vaccine therapy together with cyclophosphamide may kill more tumor cells. It is not yet known whether vaccine therapy is more effective with or without cyclophosphamide in treating patients with pancreatic cancer. PURPOSE: This randomized clinical trial is studying the side effects of vaccine therapy and to see how well it works when given with or without cyclophosphamide in treating patients undergoing chemotherapy and radiation therapy for stage I or stage II pancreatic cancer that can be removed by surgery.

Background information
Trial ID: 
NCT00727441
Other unique IDs: 
CDR0000600355
JHOC-J0810
JHOC_NA_00015858
Official title: 

A Randomized Three-Arm Neoadjuvant and Adjuvant Feasibility and Toxicity Study of a GM-CSF Secreting Allogeneic Pancreatic Cancer Vaccine Administered Either Alone or in Combination With Either a Single Intravenous Dose or Daily Metronomic Oral Doses of C

Detailed description: 

OBJECTIVES: Primary

  • To evaluate the safety and feasibility of a GVAX pancreatic cancer vaccine (GM-CSF gene-transfected allogeneic pancreatic cancer vaccine) when administered alone or in combination with a single intravenous dose or daily metronomic oral doses of cyclophosphamide as neoadjuvant and adjuvant treatment in patients with resectable stage I or II adenocarcinoma of the head, neck, or uncinate process of the pancreas.
  • To assess the immune cell infiltrates, particularly T-regulatory cells (Tregs) and CD4+ and CD8+ effector T cells, after neoadjuvant GVAX pancreat
Number to be enrolled: 
60 patients
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