M.D. Anderson Cancer Center

  • 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 = '1:83093853389028cd1080b0720e1d5b9d' 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: Methadone, morphine, or oxycodone may help relieve pain caused by cancer. It is not yet known whether methadone is more effective than morphine or oxycodone in treating pain in patients with cancer. PURPOSE: This randomized clinical trial is studying methadone to see how well it works compared with morphine or oxycodone in treating pain in patients with cancer.</p>\n', created = 1283568443, expire = 1283654843, headers = '', serialized = 0 WHERE cid = '1:83093853389028cd1080b0720e1d5b9d' 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 Randomized Comparison of Oral Methadone as a &quot;First-Switch&quot; Opioid Versus Opioid Switching Between Sustained-Release Morphine and Oxycodone for Oncology-Hematology Outpatients With Pain Management Problems: The &quot;Simply Rotate&quot; Study</p>\n', created = 1283568443, expire = 1283654843, headers = '', serialized = 0 WHERE cid = '1:e682a05167afedd5b7847872f75934f5' 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 = '1:76802cc08dc38182f705aec18b74013c' 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 the effectiveness of an opioid rotation to oral methadone versus an opioid rotation to another long-acting strong opioid (sustained-release morphine or oxycodone) in controlling pain (i.e., analgesia) in patients with cancer.</li>\n</ul>\n</p><p> Secondary\n<ul>\n<li>To compare the tolerability of an opioid rotation to oral methadone versus an opioid rotation to another long-acting strong opioid (sustained-release morphine or oxycodone).</li>\n<li>To identify a subset of patients most likely to benefit from an opioid rotation to oral methadone, in terms of significant improvement in pain control or opioid tolerability.</li>\n</ul>\n</p><p> OUTLINE: This is a multicenter study. Patients are stratified according to their baseline opioid (morphine vs oxycodone). Patients are randomized to 1 of 2 treatment arms.\n<ul>\n<li>Arm I: Patients are switched from their current opioid medication (oxycodone or morphine) to methadone. Patients receive oral methadone 2-3 times daily for 4 weeks.</li>\n<li>Arm II: Patients currently receiving oxycodone are switched to sustained-release (SR) morphine. Patients currently receiving morphine are switched to SR oxycodone. Patients receive either oral SR morphine or oxycodone 2-3 times daily for 4 weeks.</li>\n</ul>\n</p><p> Patients are assessed for pain control and complete a symptom questionnaire on days 1, 8, 15, 22, and 28.</p>\n', created = 1283568443, expire = 1283654843, headers = '', serialized = 0 WHERE cid = '1:76802cc08dc38182f705aec18b74013c' 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:b46412cca3c03de4baffb656fd8990bb' 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>Receiving ongoing care in the outpatient medical oncology setting</li>\n<li>Self-reported pain (of any cause) for which long-acting strong opioids (morphine or oxycodone) have been prescribed or administered\n<ul>\n<li>Oral morphine-equivalent daily dose (MEDD) of existing opioid regimen (long-acting or immediate-release) 40-300 mg/day</li>\n</ul>\n</li>\n<li>Worst pain score on a scale of 0 (no pain) to 10 (worst pain) of &#8805; 5 for &#8805; 1 week duration based on verbal self-report AND/OR &#8805; 1 persistently bothersome symptom attributed to an opioid side effect (e.g., fatigue, confusion, depressed level of consciousness, memory loss, personality change, anorexia, constipation, dehydration, nausea, vomiting, weight loss, pruritus, urticaria, impotence, reduced libido, and urinary retention or hesitancy)</li>\n</ul>\n</p><p> PATIENT CHARACTERISTICS:\n<ul>\n<li>None of the following conditions that could predispose the patient to prolonged QT interval-associated tachycardia:\n<ul>\n<li>Serum potassium &lt; 3.0 mg/dL</li>\n<li>Cocaine abuse within the past 3 months</li>\n<li>Family history of sudden death</li>\n<li>Advanced heart failure (ejection fraction &lt; 40% and/or NYHA class III or IV heart disease)</li>\n</ul>\n</li>\n<li>No known or suspected cognitive impairment that could interfere with adherence to the medication plan or self-report of symptoms and side effects</li>\n<li>Not pregnant or nursing</li>\n<li>Fertile patients must use effective contraception</li>\n</ul>\n</p><p> PRIOR CONCURRENT THERAPY:\n<ul>\n<li>See Disease Characteristics</li>\n<li>More than 4 weeks since prior radiotherapy or surgery for local control of cancer or pain palliation</li>\n<li>More than 60 days since prior use of the same long-acting opioid (i.e., the new long-acting opioid) that patient is switching to on the study</li>\n<li>More than 12 weeks since prior methadone therapy</li>\n<li>More than 3 days since prior and no concurrent transdermal fentanyl, oxymorphone, or buprenorphine</li>\n<li>Concurrent systemic anticancer therapy or bisphosphonates allowed provided therapy was initiated &#8805; 4 weeks ago</li>\n<li>Concurrent tricyclic antidepressants, NSAIDs, anticonvulsants, or other adjuvant analgesics or psychostimulants allowed provided therapy was initiated &#8805; 2 weeks ago\n<ul>\n<li>Dose expected to remain stable until after the first week of opioid rotation on study</li>\n</ul>\n</li>\n<li>No concurrent methadone maintenance therapy for opioid addiction</li>\n<li>No concurrent intrathecal infusion of analgesics</li>\n<li>No concurrent antiarrhythmic medications (e.g., amiodarone or quinidine)</li>\n</ul>\n</p>', created = 1283568443, expire = 1283654843, headers = '', serialized = 0 WHERE cid = '1:b46412cca3c03de4baffb656fd8990bb' 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 = '1:16e9ff6530662c4e767ab2cbf540d2e9' 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>30% reduction in patients\' total summary score for the individual composite drug toxicity score (CDTS) items [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;Yes&nbsp;]</p>\n', created = 1283568443, expire = 1283654843, headers = '', serialized = 0 WHERE cid = '1:16e9ff6530662c4e767ab2cbf540d2e9' 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:a745fbf8b3911431b7c93870d4965fdf' 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>Identification of a subset of patients most likely to benefit from an opioid rotation to oral methadone, in terms of significant improvement in pain control or opioid tolerability [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283568443, expire = 1283654843, headers = '', serialized = 0 WHERE cid = '1:a745fbf8b3911431b7c93870d4965fdf' 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 = '1:0de7d8d04cefb13c46941da6e552ec62' 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>We will evaluate the records of 30 patients that have undergone allogeneic transplant, specifically looking at engraftment rate, relapse rate, disease free survival, overall survival, causes of death and other pertinent statistics. We will compare the outcomes to appropriate historical controls.</p>\n', created = 1283568443, expire = 1283654843, headers = '', serialized = 0 WHERE cid = '1:0de7d8d04cefb13c46941da6e552ec62' 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 = '1:0e402cb682bcc968fe9643f9a4881d32' 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>Investigate hypothesis that real-time, MR-guided laser induced thermal ablation of brain lesions under real-time thermal imaging guidance is both a feasible and safe minimally-invasive technique for local, highly conformal therapy of metastatic brain tumors.</p>\n', created = 1283568443, expire = 1283654843, headers = '', serialized = 0 WHERE cid = '1:0e402cb682bcc968fe9643f9a4881d32' 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:f416e104fa38eea4c55909e23bcc574b' 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>Pilot Study Evaluating the Feasibility of Real-Time, Magnetic Resonance Thermal Imaging (MRTI) and Magnetic Resonance Imaging-Guided Laser Induced Thermal Therapy for Treatment of Metastatic Brain Tumors</p>\n', created = 1283568443, expire = 1283654843, headers = '', serialized = 0 WHERE cid = '1:f416e104fa38eea4c55909e23bcc574b' 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 = '1:308efa75b23fcc252b48b143ef45e172' 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>The Study Device and Process: The Visualase&#174; Thermal Therapy System combines 3 FDA-approved devices: the Visualase Cooled Laser Application System, which delivers the laser (energy) beams to the tumor tissue; the PhoTex 15 Diode Laser Series, which is the laser itself; and the Visualase ENVISION Workstation, which is the computer system that helps the surgeon plan and monitor your treatment. The Visualase&#174; Thermal Therapy System will be used in this study to give patients a type of therapy called Laser Interstitial Thermal Therapy (LITT). LITT uses laser light to heat and destroy the affected tissue; this is sometimes referred to as tissue ablation. In LITT, small fiber-optic applicators are placed directly into the tumor and heating is performed from the inside out, which may lead to the destruction of the tumor. During the heating process, MRTI can be used to watch the temperatures around the applicator to make sure that the tumor receives enough treatment and that the normal tissues around the tumor do not get too hot. LITT is less invasive than an open surgical procedure. There are no radiation-related side effects, or limits on the number of times it can be repeated. Also, since the procedure is performed using the MRTI, doctors can find out right away how effective the therapy was by using special imaging sequences, which may also show any surviving tumor cells. Screening: Before you can enroll on this study, you will have &quot;screening tests&quot; to help the doctor decide if you are eligible to take part in this study. The following tests and procedures will be performed within 14 days before your treatment:\n<ul>\n<li>Your medical history will be recorded, and you will be asked questions about any other treatment you have had for the metastatic brain tumor(s).</li>\n<li>You will have a complete physical exam.</li>\n<li>You will have a neurological exam. This will include an exam of the function of the nerves in your head, an exam of your visual fields, and tests of your reflexes, muscle strength, and senses.</li>\n<li>You will have an MRI scan of your brain within 30 days before LITT therapy.</li>\n<li>Women who are able to have children must have a negative urine pregnancy test within 48 hours (2 days) before treatment.</li>\n</ul>\n</p><p> Study Treatment: If you are found to be eligible to take part in the study, you will be scheduled for treatment of the brain tumor(s) using the Visualase&#174; Thermal Therapy System. You will be brought to a special operating room called the BrainSUITE&#174;. The BrainSUITE&#174; is a regular operating room that has a built-in MRI machine that can be used for taking pictures during the surgery. The imaging and procedure will be performed while you are under anesthesia (either deep sedation or fully &quot;asleep&quot;). A standard tumor biopsy will be performed. Then, using the same needle holder, the laser applicator will be placed within the tumor. MRI scans will be taken to make sure the applicator is placed properly. The biopsy and applicator placement will take about 1 hour. After that, the laser treatment will be performed. At the same time, MRI scans will be taken during the procedure. The treatment will last between 5 and 10 minutes. After treatment, follow-up MRI scans will be taken, which may take 30-60 minutes longer. If any tumor tissue is left over, the laser may be moved slightly and a second treatment performed. Once completed, the needle will be removed, and your incision will be closed in the standard way. If the tumor biopsy results reveal that the tumor has not come back, LITT will not be performed. Other treatment options which are available to you will be discussed with your doctor prior to the surgery. Study Tests: After the laser treatment, you will be observed in the hospital for 24 hours. While you are in the hospital, at about 1 day after treatment, you will have a physical and neurological exam, as well as a computed tomography (CT) scan of your brain (without using a contrast dye injected in the bloodstream) to make sure there were no problems with treatment. This is standard after any biopsy. Follow-Up Testing: You will be seen by your doctor for follow-up testing at about 1 week, 1 month, 3 months, and 6 months after your treatment. It will be very important for you to return to see your doctor at your scheduled visits, even if you are feeling fine. At the follow-up visits, your doctor will perform a complete physical and neurological exam. You will also have an MRI at all visits, starting with the 1-month visit. This is an investigational study. Each part of the Visualase&#174; Thermal Therapy System is FDA approved for use in delivering LITT to patients. Up to 22 patients will take part in this clinical research study. All will be enrolled at M. D. Anderson.</p>\n', created = 1283568443, expire = 1283654843, headers = '', serialized = 0 WHERE cid = '1:308efa75b23fcc252b48b143ef45e172' 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>Inclusion Criteria:\n<ol>\n<li>Patient or family able and willing to give informed consent.</li>\n<li>Subjects with metastatic cancer to the brain who have failed at least one conventional therapy (surgery, stereotactic radiosurgery, and/or whole brain radiotherapy). Failure is defined as local recurrence or failure of the previously treated lesion and will be determined by the treating surgeon based on a review of patient history and imaging.</li>\n<li>Tumor size &lt;/= 3.0 cm in largest diameter.</li>\n<li>MR imaging is not contraindicated for the patient</li>\n<li>Lesion(s) are clearly defined on pre-therapy contrast enhanced MRI scans as determined by the treating surgeon.</li>\n<li>Able and willing to attend all study visits.</li>\n<li>Karnofsky Performance Scale score &gt;/=70 for patients over the age of 15.</li>\n<li>Lansky Play Scale&gt;/=70 for patients 15 years of age or younger.</li>\n</ol>\n</p><p> Exclusion Criteria:\n<ol>\n<li>Patients or family unwilling or unable to give written consent.</li>\n<li>Patients who cannot physically fit in, or are too heavy for, the BrainSUITE&#174; MRI scanner</li>\n<li>Patients with contra-indications to MRI imaging, such as, but not limited to, pacemakers or defibrillators, non-compatible aneurysm clips, shrapnel, or other internal ferromagnetic objects</li>\n<li>Known sensitivity to gadolinium-DTPA</li>\n<li>Based on Treatment Planning Imaging (MR and/or CT) done on the day of treatment: -Brain edema and/or mass effect that causes midline shift or shift in wall of ventricle of more than 5 mm. -Lesions localized in the brain stem or the posterior fossa. -Lesions less than 5mm from primary branches of cerebral vessels, venous sinus, hypophysis or cranial nerves. -Evidence of recent (&lt;2 weeks) hemorrhage.</li>\n<li>Symptoms and signs of increased intracranial pressure</li>\n<li>Medical issues which prohibit the patient from undergoing surgery (as determined by the treating surgeon, anesthesiologist, IMPAC clinic, referring physician).</li>\n<li>Patients who are unable to received corticosteroids.</li>\n<li>Positive pregnancy test for women of child-bearing age.</li>\n</ol>\n</p>', created = 1283568443, expire = 1283654843, headers = '', serialized = 0 WHERE cid = '1:dfcc456aaa7f013d1e1731878656d676' 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>Primary Objectives:\n<ol>\n<li>To assess the efficacy of presurgical sunitinib therapy by evaluating time to progression.</li>\n<li>Toxicities of therapy with sunitinib in RCC in the context of presurgical therapy.</li>\n</ol>\n</p><p> Secondary (Clinical) Objectives:\n<ol>\n<li>Response rate</li>\n<li>Duration of response</li>\n<li>Overall Survival</li>\n</ol>\n</p>', created = 1283568443, expire = 1283654843, headers = '', serialized = 0 WHERE cid = '1:673b6b2a3a01dbd6738b51a87f1c9cf9' 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>The goal of this clinical research study is to find the highest safe dose of the drug 8-chloro-adenosine that can be given in the treatment of CLL. Another goal is to learn how effective the drug is at treating leukemia.</p>\n', created = 1283568443, expire = 1283654843, headers = '', serialized = 0 WHERE cid = '1:3f264c9dd7583305ed9f78f6d454560e' 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 I Study OF 8-Chloro-Adenosine in Previously Treated Patients With Chronic Lymphocytic Leukemia.</p>\n', created = 1283568443, expire = 1283654843, headers = '', serialized = 0 WHERE cid = '1:a048e82e80af53aabc50ef8fc5d7d0c7' 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 = '1:63b8a71951649fad5a69bdd94ce30917' 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>8-Chloro-adenosine is a new drug similar to other drugs already approved by the FDA for the treatment of CLL and other types of cancer. 8-Chloro-adenosine belongs to a class of chemotherapy drugs called purine analogues that work to treat cancer by their ability to interfere with cancer cell metabolism, causing cell death. Before you can start treatment on the study, you will have what are called &quot;screening tests&quot;. These tests will help the doctor decide if you are eligible to take part in the study. You will have a complete medical history and physical exam. Routine blood tests (about 1 tablespoon) will be performed. Your treating doctor may order other tests if he/she thinks they are necessary. Women who are able to have children must have a negative blood pregnancy test. If you are eligible, you will receive 8-chloro-adenosine as an infusion into a vein once a day for five days in a row. Each infusion will take about 1 hour. This 5-day treatment will be repeated every 4 weeks (&#177; 3 days) (1 course). This is a dose escalation study. Patients treated on this study will be treated in groups of 3. The first group will receive the lowest dose of the drug. If the type, number, and severity of any side effects experienced are acceptable, the next group of 3 patients will receive the next higher dose of drug. The dose of drug will be increased for each new group until the highest safe dose is found. For your first course only, you will have blood tests (about 1 tablespoon) on Day 3 and Day 5 of treatment to monitor for safety. After that, you will have weekly (&#177; 3 days) evaluations and routine blood tests (about 1 tablespoon) in the clinic at UTMDACC. During these evaluations, you will also have a physical exam and be asked about any side effects you may have experienced. You will be evaluated for improvement in your CLL. If your disease is stable or responding to treatment, you may continue with treatment. If your disease improves to the point that your doctor feels that you are in complete remission, he or she will request you to have a bone marrow biopsy to confirm complete remission. If your disease is worsening and it appears that the treatment is not helping you, then you will stop treatment with 8-chloro-adenosine and may begin other treatment at the direction of your treating doctor. If you have unacceptable side effects, you may be taken off treatment. If you stop treatment, you will be evaluated in the clinic and have routine blood tests (about 1 tablespoon) once a week for the first month, twice a month for the next 2 months, then once a month from then on. During these evaluations, you will have a physical exam and be asked about any side effects you may have experienced. If you begin other treatment, your scheduled follow-up will end. This is an investigational study. 8-Chloro-adenosine is not approved by the FDA and is not commercially available. A total of up to 28 patients will take part in this study. All will be enrolled and treated at UTMDACC. Optional Procedures: If you agree, you will have additional blood and urine samples taken. These blood samples will be taken from a separate IV site from the one being used to give you the 8-chloro-adenosine. Blood samples (about 2 teaspoons each) will be taken before your first dose of 8-chloro-adenosine, at the beginning, middle, and end of the infusion of drug, then 2, 4, 6-8, 10-12, and 24 hours after the end of the infusion. In addition, blood samples (about 2 teaspoons each) will be taken before and at the end of infusion for doses 2,3,4, and 5, if you receive these infusions. Urine samples will be collected before your first infusion, within 8 hours of this infusion, within 16 hours, and then within 24 hours of the infusion. You do not have to agree to take part in the optional procedures in order to receive treatment on this study.</p>\n', created = 1283568443, expire = 1283654843, headers = '', serialized = 0 WHERE cid = '1:63b8a71951649fad5a69bdd94ce30917' 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>Inclusion Criteria:\n<ul>\n<li>Patients must have a diagnosis of chronic lymphocytic leukemia and must be previously treated with more than one treatment regimen, including a purine-analogue based treatment.</li>\n<li>Patients must be Rai Stage III or IV OR Rai Stage 0-II and have one or more criteria for active disease as defined by the NCI-Working Group as: a) weight loss of more than 10% in the last 6 months; b) fatigue; c) fever or night sweats without evidence of infection; d) progressive anemia or thrombocytopenia; e) progressive lymphocytosis with a lymphocyte doubling time &lt;/= 6 months; or f) marked hypogammaglobulinemia or paraproteinemia.</li>\n<li>All patients must have a Zubrod performance status of &lt;/= 2.</li>\n<li>All patients must be age &gt;/= 18 years.</li>\n<li>Patients may not receive concurrent treatment for their CLL and must have been off treatment (chemotherapy, immunotherapy, or radiotherapy) for 4 weeks prior to treatment on this study and recovered from toxic effects of that therapy.</li>\n<li>All patients must have adequate renal function indicated by serum creatinine &lt;/=2.5x upper limits of normal (ULN) and adequate liver function indicated by ALT or AST &lt;/= 2.5x ULN AND total bilirubin &lt;/= 2.5x ULN.</li>\n<li>All patients must have a pre-treatment platelet count of &gt;/= 50,000 /&#181;l and not require transfusion to maintain this platelet count.</li>\n<li>All patients or appropriate surrogate must provide informed consent.</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Patients with active uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia purpura.</li>\n<li>Patients with active uncontrolled fungal, bacterial, or viral infection.</li>\n<li>Patients who are pregnant or breast-feeding.</li>\n</ul>\n</p>', created = 1283568443, expire = 1283654843, headers = '', serialized = 0 WHERE cid = '1:34719d5356e1597ddf2ca22dec8b1cbd' 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>We know that treatment for rectal cancer can impact women\'s sexual function. Cancer patients seek counseling for lots of reasons. It often helps them cope because they can express their feelings with a trained professional. This study is open to women who have been treated for rectal cancer. It involves a new type of counseling. It will teach women skills that they can use to improve their sex lives. These skills may also improve physical and emotional well-being. We will compare the new type of counseling with the standard care women receive after treatment for rectal cancer.</p>\n', created = 1283568443, expire = 1283654843, headers = '', serialized = 0 WHERE cid = '1:3dbc4d38e8f7e24b5651e0742b1c98c6' 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>Primary Objectives:\n<ul>\n<li>To determine the clinical/radiographic complete and partial response rate after induction chemotherapy with docetaxel, cisplatin and fluorouracil (TPF)</li>\n<li>To improve local tumor control to 80% at 2 years</li>\n</ul>\n</p><p> Secondary Objectives:\n<ul>\n<li>Disease specific-survival and overall survival rates</li>\n<li>Organ preservation (orbital, maxillary, cranial) rate</li>\n<li>Patterns of treatment failure (local, regional, and distant)</li>\n<li>Acute and late treatment-related toxicity</li>\n<li>The effect of treatment on Quality of Life with and without surgery</li>\n<li>To evaluate the effects of induction chemotherapy on biological markers that could serve as surrogates for response and predictors of long-term outcome.</li>\n</ul>\n</p>', created = 1283568443, expire = 1283654843, headers = '', serialized = 0 WHERE cid = '1:815f07893b00f29d15cb4c3e8bfddda0' 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 = '1:12c265d68c2fa995779f41baec9f6b0c' 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 Induction Therapy With Docetaxel, Cisplatin and Fluorouracil in Previously Untreated Patients With Locally Advanced Squamous Cell or Undifferentiated Carcinoma of the Paranasal Sinuses</p>\n', created = 1283568443, expire = 1283654843, headers = '', serialized = 0 WHERE cid = '1:12c265d68c2fa995779f41baec9f6b0c' 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:fc2f5a7c780cfe34bed638072f3b6017' 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>The Study Drug\n<ul>\n<li>Docetaxel is designed to stop the growth of cancer cells, which may cause the cells to die. It is believed to be weakly effective at killing blood vessels in cancer cells as well.</li>\n<li>Cisplatin has an atom at its center that contains platinum. The platinum is supposed to poison the cancer cells, which may cause them to die.</li>\n<li>5-Fluorouracil is designed to destroy cancer cells by preventing them from dividing and multiplying.</li>\n</ul>\n</p><p> Study Drug Administration If you are found to be eligible to take part in this study, you will receive 5-fluorouracil through a needle in your vein, non-stop, on Days 1-4 of each 21-day study &quot;cycle&quot;. On Day 1 only, you will receive docetaxel over 1 hour and cisplatin over 30-120 minutes. You will receive 2-3 cycles of therapy. If you are having side effects, the study doctor may schedule you to receive the study drugs on a longer cycle. Study Visits During Weeks 1-3 of Cycles 1 and 2, you will have study visits every week. At these visits, the following tests and procedures will be performed:\n<ul>\n<li>Blood (about 2 teaspoons) will be drawn for routine tests.</li>\n<li>Your weight will be measured.</li>\n<li>Your doctor will ask about any side effects you may be experiencing.</li>\n<li>You will have a physical exam.</li>\n<li>Your skin and inside of your mouth will be examined by your doctor.</li>\n</ul>\n</p><p> Once Cycle 2 is completed, you will have the following tests and procedures performed to learn if the disease has responded to the therapy:\n<ul>\n<li>You will have a physical exam.</li>\n<li>You will have a nasal endoscopy.</li>\n<li>You will have an MRI.</li>\n<li>Your doctor will ask about any side effects you may be experiencing.</li>\n<li>If your doctor thinks it is necessary, you will have a CT scan.</li>\n</ul>\n</p><p> Chemotherapy or Radiotherapy Based on the results of the tests and procedures performed to check to see if the disease has responded, your doctor will decide your next treatment. If you respond partly or completely, you will receive a 3rd cycle of chemotherapy. You will follow the same schedule as you did during the first 2 cycles. Once you complete the 3 cycles of chemotherapy, you will begin chemoradiation. Your doctor will discuss this with you in more detail and you will receive a separate consent form. If the disease does not responded partly or completely, you will have surgery followed by radiotherapy. Before surgery you will be asked to sign a separate informed consent. Risks will be discussed with your treating doctor and will depend on the type of surgery. Before radiotherapy you will be asked to sign a separate informed consent that will describe possible risks. Additional Cycles If the disease responds partly or completely, you will receive an additional (third) cycle of therapy. If you have the additional cycle, you will follow the same schedule as you did during Cycles 1 and 2. Study Visit After Chemoradiation If you receive chemoradiation, after your last chemotherapy treatment you will have the following tests and procedures performed:\n<ul>\n<li>You will have a physical exam.</li>\n<li>You will have a nasal endoscopy.</li>\n<li>You will have an MRI.</li>\n<li>Your doctor will ask about any side effects you may be experiencing.</li>\n<li>If your doctor thinks it is necessary, you will also have a CT or positron emission tomography (PET)-CT scan.</li>\n</ul>\n</p><p> Length of Study You will remain on study treatment for 16-20 weeks. You will be taken off study early if the disease gets worse or intolerable side effects occur. Follow-up/End-of-Treatment Visits If the disease responded completely while you were on study, you will have follow-up visits every 3 months during Years 1-2, every 4 months during Year 3, and every 6 months during Years 4-5. If the disease did not respond completely and you are having side effects at the end-of-study visit, you will have follow-up visits every 4 weeks until the side effects go away. At each visit, the following tests and procedures will be performed:\n<ul>\n<li>Your complete medical history will be recorded.</li>\n<li>You will have a physical exam, including measurement of your vital signs.</li>\n<li>You will have a nasal endoscopy.</li>\n<li>The nerve function in your head and neck will be checked.</li>\n<li>Your doctor will ask about any side effects you may be experiencing.</li>\n<li>One (1) time each year, blood (about 2 teaspoons) will be drawn for a thyroid function test.</li>\n</ul>\n</p><p> Additional information At any time during the study, you will have an MRI if your doctor thinks it is necessary. This is an investigational study. Docetaxel is FDA approved for the treatment of certain types of breast cancer, gastric cancer, prostate cancer, and advanced squamous cell carcinoma of the head and neck. Cisplatin is FDA approved to be used together with other drugs to treat advanced ovarian cancer, testicular cancer, locally advanced squamous cell carcinoma of the head and neck, late-stage cervical cancer, and non-small cell lung cancer. 5-fluorouracil is FDA approved to be used with other drugs to treat metastatic colorectal cancer, locally advanced squamous cell carcinoma of the head and neck, and gastric adenocarcinoma. The use of these drugs to treat cancer of the paranasal sinuses is investigational. Up to 45 patients will take part in this study. All will be enrolled at M. D. Anderson.</p>\n', created = 1283568443, expire = 1283654843, headers = '', serialized = 0 WHERE cid = '1:fc2f5a7c780cfe34bed638072f3b6017' 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 = '1:2265dfa644e2b172d19a9b8c57e12d9f' 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>Inclusion Criteria:\n<ol>\n<li>Patients with cytologic or histological diagnosis of squamous cell carcinoma or poorly differentiated carcinoma of the nasal cavity and paranasal sinuses.</li>\n<li>2. Stage II-IV disease; T 2-4, N any, M0. Measurable disease is required with the following criteria: Measurable lesions can be accurately measured, with at least one diameter &gt;= 1.0 cm by spiral CT scan or MRI. Lesions can be bidimensionally measurable or unidimensionally measurable. Every effort should be made to measure lesions in two dimensions. Measurable disease is present if the patient has one or more measurable lesions. Non-measurable lesions/disease are all other lesions, including small lesions (those with measurements &lt; 2.0 cm; or &lt; 1.0 cm with spiral CT). </li>\n<li>Karnofsky performance status of &gt;= 70 or ECOG PS 0-2.</li>\n<li>Age &gt; 16 years.</li>\n<li>Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (AGC) of &gt;/= 1500 cells/mm3 and platelet count of &gt;/= 140,000 cells/mm3;</li>\n<li>Hepatic Parameters: Total Bilirubin &lt;/= ULN AST and ALT and Alkaline Phosphatase must be within the range allowing for eligibility. In determining eligibility the more abnormal of the two values (AST or ALT) should be used. **Refer to table in protocol pg.6**</li>\n<li>Hemoglobin &gt;/= 10.0g/dL</li>\n<li>Creatinine clearance &gt; 50 ml/min determined by 24 hour collection or nomogram: CrCl male = (140 - age) x (wt in kg)/serum Cr x 72 CrCl female = 0.85 x (CrCl male)</li>\n<li>Patients should have no debilitating acute or chronic co-morbid condition, or acute serious infection that in the opinion of the attending medical oncologist would preclude safe administration of the prescribed chemotherapy treatment.</li>\n<li>WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study medication.</li>\n<li>Patients must sign a study-specific informed consent form.</li>\n</ol>\n</p><p> Exclusion Criteria:\n<ol>\n<li>Histology other than squamous cell or poorly differentiated carcinoma.</li>\n<li>Evidence of distant metastases (below the clavicle) by clinical or radiographic measures.</li>\n<li>Karnofsky performance status &lt; 70 or ECOG&gt;2 (Appendices B and BB).</li>\n<li>Pre-existing peripheral neuropathy CTCAE grade 2 or worse or pre-existing severe bilateral hearing deficits.</li>\n<li>Prior chemotherapy, within the previous 3 years.</li>\n<li>Prior radiotherapy to the paranasal sinus region or the upper neck.</li>\n<li>Initial surgical resection rendering the patient clinically and radiologically disease free.</li>\n<li>Simultaneous primary invasive cancers.</li>\n<li>Patients with a past history of malignancy (excluding non melanoma skin cancers, and cancers treated &gt; 3 years prior for which patient remains continuously disease free).</li>\n<li>Men and Women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 3 months after the study. Subjects who are men must also agree to use effective contraception. Note: WOCBP must be using an adequate method of contraception throughout the study and for up to 3 months after the study. Adequate methods of contraception will include (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner).</li>\n<li>Women who are pregnant or breastfeeding.</li>\n<li>Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80.</li>\n</ol>\n</p>', created = 1283568443, expire = 1283654843, headers = '', serialized = 0 WHERE cid = '1:2265dfa644e2b172d19a9b8c57e12d9f' 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:bea1f6a6111b8be9c8296dd9e24d193a' 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>Primary: 1. To determine reliability of glucose monitoring device as compared with point of care / fingerstick glucose testing. Secondary:\n<ol>\n<li>To determine what conditions, if any, where continuous glucose monitoring device may not be reliable.</li>\n<li>To determine if the continuous glucose monitor provides more clinically important information for determining insulin infusion protocol changes as compared with point-of-care testing.</li>\n</ol>\n</p>', created = 1283568443, expire = 1283654843, headers = '', serialized = 0 WHERE cid = '1:bea1f6a6111b8be9c8296dd9e24d193a' 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 = '1:996da622d441a4275311b289aa92d356' 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>Continuous Glucose Monitoring Device Compared With Point-of-Care Glucose Testing in the ICU</p>\n', created = 1283568443, expire = 1283654843, headers = '', serialized = 0 WHERE cid = '1:996da622d441a4275311b289aa92d356' 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:f8dd398d346b31e0ef4b1a91c0a707db' 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>The Study Device: The Guardian&#174; blood-sugar monitoring device is designed to automatically record blood sugar levels many times per hour, without requiring multiple fingersticks. It uses a blood sugar &quot;sensor&quot; (an electronic measuring device) that is about the size of a beeper. The sensor is attached to a small catheter that has a small needle in it. Once the catheter is inserted in the skin, the needle is removed right away. Use of Study Device: If you agree to take part in this study, while you are in the ICU, the catheter and needle part of the study device will be inserted under the skin of your abdomen or thigh. The device will automatically measure your blood sugar every 10 seconds so the data can be reviewed by the research staff. The needle will be removed right away. The catheter must be changed every 3 days by the research staff. You will have the study device in place for 15 days (or until you leave the ICU, whichever comes first). Standard Monitoring of Blood Sugar Levels: While you are on study, your blood sugar will also be monitored according to the standard of care. This will be in the form of having your blood sugar checked by using a small needle to prick the tip of your finger every hour or more, as necessary. The blood sugar measurements from the study device will not be used in any way to affect any decisions about your blood sugar monitoring or care. Length of Study Participation: After the study device is removed from your body for the last time (after 15 days or when you leave the ICU), you will be considered off study. If intolerable side effects occur, or an infection occurs that seems to have been caused by the study device, you will be taken off study early. This is an investigational study. The study device is commercially available and FDA approved for monitoring blood sugar levels for outpatient (outside of the hospital) use. Using the device in patients who are in the hospital is considered experimental. At this time, it is only being used in this way in research.</p>\n', created = 1283568443, expire = 1283654843, headers = '', serialized = 0 WHERE cid = '1:f8dd398d346b31e0ef4b1a91c0a707db' 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 = '1:1c2b52b42a74246fcb758d2b398851e5' 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>Inclusion Criteria:\n<ol>\n<li>Patients in any of our University of Texas collaborative intensive care units.</li>\n<li>Critically ill patients on an insulin infusion protocol</li>\n</ol>\n</p><p> Exclusion Criteria:\n<ol>\n<li>Patients or their legal representatives who do not consent</li>\n<li>Patients with large areas of skin affected so as not to allow implantation of device.</li>\n<li>Patients &lt; 18 years of age</li>\n</ol>\n</p>', created = 1283568443, expire = 1283654843, headers = '', serialized = 0 WHERE cid = '1:1c2b52b42a74246fcb758d2b398851e5' 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 = '1:504a5645b7463d7db99c6db55152b3b5' 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>The purpose of this study is to find out the effects (good and bad) Alpha-Lipoic Acid (ALA) has on preventing a side effect of platinum-containing chemotherapy called peripheral neuropathy. In this study, one group of subjects will receive Alpha-Lipoic Acid (ALA) and another group will receive a placebo control pill. A placebo control pill is a &quot;look-a-like&quot; pill but does not have any medication in it. Another name for placebo pill is &quot;sugar pill.&quot; Peripheral neuropathy is an abnormal, uncomfortable, often painful, sensations and feelings in hands or feet. The sensations and feelings in the hands and feet can effect the normal use of the hands and feet, such as in buttoning, writing, typing, sewing, picking up small objects, and walking. Currently there is no standard or reliable therapy to prevent this type of neuropathy. Alpha-Lipoic Acid (ALA) is a dietary supplement that is supposed to prevent or reduce the symptoms.</p>\n', created = 1283568443, expire = 1283654843, headers = '', serialized = 0 WHERE cid = '1:504a5645b7463d7db99c6db55152b3b5' 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 = '1:70f1ec837eef02e5b447288647e7b6fd' 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>Prevention of Cisplatin- or Oxaliplatin-Induced Peripheral Neuropathy With Alpha-Lipoic Acid: A Placebo-Controlled Phase III Trial</p>\n', created = 1283568443, expire = 1283654843, headers = '', serialized = 0 WHERE cid = '1:70f1ec837eef02e5b447288647e7b6fd' 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>&nbsp;</p>\n', created = 1283568443, expire = 1283654843, headers = '', serialized = 0 WHERE cid = '1:cc7819055cde3194bb3b136bad5cf58d' 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:c558358185700b1174b6366c0ed65ec1' 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>Scheduled to receive a cisplatin- or oxaliplatin-containing chemotherapy regimen for cancer</li>\n<li>No established clinical neuropathy</li>\n<li>No clinically evident CNS metastases, including leptomeningeal metastases</li>\n</ul>\n</p><p> PATIENT CHARACTERISTICS: AGE\n<ul>\n<li>Not specified PERFORMANCE STATUS</li>\n<li>Not specified LIFE EXPECTANCY</li>\n<li>Not specified HEMATOPOIETIC</li>\n<li>Not specified HEPATIC</li>\n<li>Bilirubin &lt; 2 mg/dL RENAL</li>\n<li>Creatinine &lt; 2 mg/dL OR</li>\n<li>Creatinine clearance &gt; 45 mL/min OTHER</li>\n<li>Not pregnant or nursing</li>\n<li>Negative pregnancy test</li>\n<li>Fertile patients must use effective contraception</li>\n<li>Must have a normal state of arousal</li>\n<li>No confusion or memory or concentration deficit</li>\n<li>No history of diabetes mellitus requiring oral medication or insulin treatment</li>\n<li>No chronic alcoholism</li>\n<li>No other active CNS disease (e.g., dementia or encephalopathy)</li>\n</ul>\n</p><p> PRIOR CONCURRENT THERAPY: BIOLOGIC THERAPY\n<ul>\n<li>Not specified CHEMOTHERAPY</li>\n<li>See Disease Characteristics</li>\n<li>No carboplatin, vincristine, vinblastine, paclitaxel, or docetaxel for 6 months prior, during, and 6 months after study treatment ENDOCRINE THERAPY</li>\n<li>Not specified RADIOTHERAPY</li>\n<li>Not specified SURGERY</li>\n<li>Not specified OTHER</li>\n<li>Concurrent medications that can modify peripheral neuropathy (e.g., gabapentin, lamotrigine, carbamazepine, phenytoin, or tricyclic antidepressants) are allowed provided there is no dose adjustment within 2 weeks before study entry and during study participation</li>\n<li>No concurrent vitamin E (including multivitamins that contain vitamin E) &#8805; 100 IU per day</li>\n<li>No concurrent physical modality (e.g., annodyne [monochromatic near-infrared photoenergy, 890 nm], microcurrent, or transcutaneous electrical neural stimulation) for peripheral neuropathy related symptoms unless physical or occupational therapy for functional training</li>\n</ul>\n</p>', created = 1283568443, expire = 1283654843, headers = '', serialized = 0 WHERE cid = '1:c558358185700b1174b6366c0ed65ec1' 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>Group differences in change scores from baseline at 6-8, 12, 24, 36, and 48 weeks [&nbsp;Time&nbsp;Frame:&nbsp;2 years&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283568443, expire = 1283654843, headers = '', serialized = 0 WHERE cid = '1:b7017f2a141d6075d915f615de63060c' 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 courses received [&nbsp;Time&nbsp;Frame:&nbsp;2 years&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283568443, expire = 1283654843, headers = '', serialized = 0 WHERE cid = '1:62249da00011075adfe8607794114713' 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 = '1:7322b04da0615ce694db691b0a4081dc' 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>Optimal tumor response [&nbsp;Time&nbsp;Frame:&nbsp;2 years&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283568443, expire = 1283654843, headers = '', serialized = 0 WHERE cid = '1:7322b04da0615ce694db691b0a4081dc' 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:e7af09393358d3fa6fa9d69209b2b162' 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>Primary Objectives:\n<ul>\n<li>Evaluate safety, feasibility, persistence, and anti-tumor effect of infused haploidentical donor-derived natural killer (NK) cells and low-dose interleukin-2 (IL-2).</li>\n</ul>\n</p><p> Secondary Objectives:\n<ul>\n<li>Quantification of cytokine levels;</li>\n<li>Assessment of NK cell immunophenotype and function.</li>\n</ul>\n</p>', created = 1283568443, expire = 1283654843, headers = '', serialized = 0 WHERE cid = '1:e7af09393358d3fa6fa9d69209b2b162' in /persistent/html/includes/cache.inc on line 109.

Methadone, Morphine, or Oxycodone in Treating Pain in Patients With Cancer

Recruitment status: 
Recruiting

RATIONALE: Methadone, morphine, or oxycodone may help relieve pain caused by cancer. It is not yet known whether methadone is more effective than morphine or oxycodone in treating pain in patients with cancer. PURPOSE: This randomized clinical trial is studying methadone to see how well it works compared with morphine or oxycodone in treating pain in patients with cancer.

Background information
Trial ID: 
NCT00726830
Other unique IDs: 
CDR0000598283
MDA-2007-0791
Official title: 

A Randomized Comparison of Oral Methadone as a "First-Switch" Opioid Versus Opioid Switching Between Sustained-Release Morphine and Oxycodone for Oncology-Hematology Outpatients With Pain Management Problems: The "Simply Rotate" Study

Detailed description: 

OBJECTIVES: Primary

  • To compare the effectiveness of an opioid rotation to oral methadone versus an opioid rotation to another long-acting strong opioid (sustained-release morphine or oxycodone) in controlling pain (i.e., analgesia) in patients with cancer.

Number to be enrolled: 
300 patients

Bone Marrow Transplant Chart Review for RIC

We will evaluate the records of 30 patients that have undergone allogeneic transplant, specifically looking at engraftment rate, relapse rate, disease free survival, overall survival, causes of death and other pertinent statistics. We will compare the outcomes to appropriate historical controls.

Background information
Other unique IDs: 
29021

Magnetic Resonance Temperature Imaging & Imaging-Guided Laser Induced Thermal Therapy for Treatment of Metastatic Brain Tumors

Recruitment status: 
Recruiting

Investigate hypothesis that real-time, MR-guided laser induced thermal ablation of brain lesions under real-time thermal imaging guidance is both a feasible and safe minimally-invasive technique for local, highly conformal therapy of metastatic brain tumors.

Background information
Trial ID: 
NCT00720837
Other unique IDs: 
2007-0610
Official title: 

Pilot Study Evaluating the Feasibility of Real-Time, Magnetic Resonance Thermal Imaging (MRTI) and Magnetic Resonance Imaging-Guided Laser Induced Thermal Therapy for Treatment of Metastatic Brain Tumors

Detailed description: 

The Study Device and Process: The Visualase® Thermal Therapy System combines 3 FDA-approved devices: the Visualase Cooled Laser Application System, which delivers the laser (energy) beams to the tumor tissue; the PhoTex 15 Diode Laser Series, which is the laser itself; and the Visualase ENVISION Workstation, which is the computer system that helps the surgeon plan and monitor your treatment. The Visualase® Thermal Therapy System will be used in this study to give patients a type of therapy called Laser Interstitial Thermal Therapy (LITT).

Number to be enrolled: 
22 patients

Pre-Surgical Sutent in Renal Cell Carcinoma (RCC)

Primary Objectives:

  1. To assess the efficacy of presurgical sunitinib therapy by evaluating time to progression.
  2. Toxicities of therapy with sunitinib in RCC in the context of presurgical therapy.

Secondary (Clinical) Objectives:

  1. Response rate
  2. Duration of response
  3. Overall Survival

Background information
Other unique IDs: 
2007-0511

8-Chloro-Adenosine in Chronic Lymphocytic Leukemia

Trial phase: 
Phase I
Recruitment status: 
Recruiting

The goal of this clinical research study is to find the highest safe dose of the drug 8-chloro-adenosine that can be given in the treatment of CLL. Another goal is to learn how effective the drug is at treating leukemia.

Background information
Trial ID: 
NCT00714103
Other unique IDs: 
2004-0144
3550
Official title: 

A Phase I Study OF 8-Chloro-Adenosine in Previously Treated Patients With Chronic Lymphocytic Leukemia.

Detailed description: 

8-Chloro-adenosine is a new drug similar to other drugs already approved by the FDA for the treatment of CLL and other types of cancer. 8-Chloro-adenosine belongs to a class of chemotherapy drugs called purine analogues that work to treat cancer by their ability to interfere with cancer cell metabolism, causing cell death. Before you can start treatment on the study, you will have what are called "screening tests". These tests will help the doctor decide if you are eligible to take part in the study. You will have a complete medical history and physical exam.

Number to be enrolled: 
28 patients

The Sexual Health of Rectal Cancer Patients

We know that treatment for rectal cancer can impact women's sexual function. Cancer patients seek counseling for lots of reasons. It often helps them cope because they can express their feelings with a trained professional. This study is open to women who have been treated for rectal cancer. It involves a new type of counseling. It will teach women skills that they can use to improve their sex lives. These skills may also improve physical and emotional well-being. We will compare the new type of counseling with the standard care women receive after treatment for rectal cancer.

Background information
Other unique IDs: 
08-073

Induction Therapy-Docetaxel, Cisplatin and Fluorouracil in Untreated Advanced Squamous Cell or Undifferentiated Carcinoma of the Paranasal Sinuses

Trial phase: 
Phase II
Recruitment status: 
Recruiting

Primary Objectives:

  • To determine the clinical/radiographic complete and partial response rate after induction chemotherapy with docetaxel, cisplatin and fluorouracil (TPF)
  • To improve local tumor control to 80% at 2 years

Secondary Objectives:

  • Disease specific-survival and overall survival rates
  • Organ preservation (orbital, maxillary, cranial) rate
  • Patterns of treatment failure (local, regional, and distant)
  • Acute and late treatment-related toxicity
  • The effect of treatment on Quality of Life with and without surgery
  • To evaluate the effects of induction chemotherapy on biological markers that could serve as surrogates for response and predictors of long-term outcome.

Background information
Trial ID: 
NCT00707473
Other unique IDs: 
2007-0433
Official title: 

Phase II Trial of Induction Therapy With Docetaxel, Cisplatin and Fluorouracil in Previously Untreated Patients With Locally Advanced Squamous Cell or Undifferentiated Carcinoma of the Paranasal Sinuses

Detailed description: 

The Study Drug

  • Docetaxel is designed to stop the growth of cancer cells, which may cause the cells to die. It is believed to be weakly effective at killing blood vessels in cancer cells as well.
  • Cisplatin has an atom at its center that contains platinum. The platinum is supposed to poison the cancer cells, which may cause them to die.
  • 5-Fluorouracil is designed to destroy cancer cells by preventing them from dividing and multiplying.

Number to be enrolled: 
45 patients

Continuous Glucose Monitoring in Critically Ill

Recruitment status: 
Recruiting

Primary: 1. To determine reliability of glucose monitoring device as compared with point of care / fingerstick glucose testing. Secondary:

  1. To determine what conditions, if any, where continuous glucose monitoring device may not be reliable.
  2. To determine if the continuous glucose monitor provides more clinically important information for determining insulin infusion protocol changes as compared with point-of-care testing.

Background information
Trial ID: 
NCT00707434
Other unique IDs: 
2007-0616
Official title: 

Continuous Glucose Monitoring Device Compared With Point-of-Care Glucose Testing in the ICU

Detailed description: 

The Study Device: The Guardian® blood-sugar monitoring device is designed to automatically record blood sugar levels many times per hour, without requiring multiple fingersticks. It uses a blood sugar "sensor" (an electronic measuring device) that is about the size of a beeper. The sensor is attached to a small catheter that has a small needle in it. Once the catheter is inserted in the skin, the needle is removed right away.

Number to be enrolled: 
60 patients

Alpha-Lipoic Acid in Preventing Peripheral Neuropathy in Patients Receiving Chemotherapy for Cancer

Trial phase: 
Phase III
Recruitment status: 
Recruiting

The purpose of this study is to find out the effects (good and bad) Alpha-Lipoic Acid (ALA) has on preventing a side effect of platinum-containing chemotherapy called peripheral neuropathy. In this study, one group of subjects will receive Alpha-Lipoic Acid (ALA) and another group will receive a placebo control pill. A placebo control pill is a "look-a-like" pill but does not have any medication in it. Another name for placebo pill is "sugar pill." Peripheral neuropathy is an abnormal, uncomfortable, often painful, sensations and feelings in hands or feet. The sensations and feelings in the hands and feet can effect the normal use of the hands and feet, such as in buttoning, writing, typing, sewing, picking up small objects, and walking. Currently there is no standard or reliable therapy to prevent this type of neuropathy. Alpha-Lipoic Acid (ALA) is a dietary supplement that is supposed to prevent or reduce the symptoms.

Background information
Trial ID: 
NCT00705029
Other unique IDs: 
0120070249
Official title: 

Prevention of Cisplatin- or Oxaliplatin-Induced Peripheral Neuropathy With Alpha-Lipoic Acid: A Placebo-Controlled Phase III Trial

Detailed description: 

 

Number to be enrolled: 
244 patients

Haploidentical Natural Killer (NK) Cells in Patients With Relapsed Neuroblastoma Post Autologous Stem Cell Transplant

Primary Objectives:

  • Evaluate safety, feasibility, persistence, and anti-tumor effect of infused haploidentical donor-derived natural killer (NK) cells and low-dose interleukin-2 (IL-2).

Secondary Objectives:

  • Quantification of cytokine levels;
  • Assessment of NK cell immunophenotype and function.

Background information
Other unique IDs: 
2006-0752
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