Memorial Sloan-Kettering Cancer Center

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RAD001 and Lenalidomide in the Treatment of Subjects With Relapsed and Relapsed/Refractory Multiple Myeloma

Trial phase: 
Phase I
Recruitment status: 
Recruiting

The purpose of this research study is to determine the highest dose of lenalidomide and RAD001 that can be given without causing too many serious side effects. Another goal of this research study is to look at how the participants cancer may respond to the study treatment. Additionally, we wish to learn more about how the body breaks down and gets rid of the study drugs. We will also try to find substances in the blood (biomarkers) that may help predict how myeloma will respond to study treatment.

Background information
Trial ID: 
NCT00729638
Other unique IDs: 
07-288
RV-MM-PI-142
Official title: 

An Open-Label Phase I Study of the Safety of and Efficacy of RAD001 in Combination With Lenalidomide in the Treatment of Subjects With Relapsed and Relapsed/Refractory Multiple Myeloma

Detailed description: 
  • Researchers are looking for the highest doses of RAD001 and lenalidomide used in combination that can be given safely so small groups of people will be enrolled in steps in this trial. The first group will be given a certain dose of RAD001 and a certain dose of lenalidomide. If they have few or manageable side effects, the next small group of people will be enrolled with a higher dose of RAD001 and/or a higher dose of lenalidomide. This will continue until the highest dose of the drugs used is determined.
  • Study treatment will be given in 28 day cycles.
Number to be enrolled: 
40 patients

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

Multiple Respiration-Correlated Cone Beam Computed Tomography (CT) Scans to Reduce Target Positioning Errors in Radiotherapy Treatment of Thoracic Cancer

Trial phase: 
Phase I
Recruitment status: 
Recruiting

The purpose of this study is to use cone-beam CT scans to more accurately position the tumor during radiation and to see whether this method is more effective than the standard method of using 2D images (portal images), which is a type of X-ray. Cone-beam CT is a type of CT scanner attached to the treatment accelerator that produces 3D images of the patient. The ability to eliminate the tumor with radiation depends in part on the accuracy of delivering the radiation to the lung. The position of the tumor changes because of normal breathing. Therefore, we want to improve the accuracy of the way the radiation is delivered to the tumor. With cone-beam CT scans taken before and during your treatment, we will be able to determine the location of the tumor with 3D images, measure how much the tumor moves as you breathe, and then position you so that the tumor will get the best delivery of radiation.

Background information
Trial ID: 
NCT00722605
Other unique IDs: 
08-080
Official title: 

The Use of Multiple Respiration-Correlated Cone Beam CT Scans to Reduce Target Positioning Errors in Radiotherapy Treatment of Thoracic Cancer.

Detailed description: 

 

Number to be enrolled: 
20 patients

Novel Capecitabine Dosing Schedule in Combination With Lapatinib, Based on the Norton-Simon Mathematical Method in Patients With HER2 Overexpressed/Amplified, Trastuzumab (Herceptin) -Refractory, Metastatic Breast Cancer

HER2 is a protein that sits on the surface of breast cancer cells in some people. Because you are one of these people, your breast cancer is called "HER2-positive." The HER2 protein is involved in the growth of your breast cancer. Certain drugs can interfere with the ability of the HER2 protein to cause breast cancer growth. Trastuzumab is one of these drugs. You must have already received trastuzumab as treatment for your breast cancer to be considered for this study. Other drugs are being studied in women with HER2-positive breast cancer. Lapatinib (Tykerb™) blocks signals that stimulate HER2-positive breast cancers to grow. The FDA approved lapatinib for use with capecitabine (Xeloda™) in patients who have metastatic breast cancer that has grown or spread after treatment with trastuzumab. Capecitabine was approved by the FDA in 1998 for treating metastatic breast cancer. Capecitabine is a pill that blocks the way cancer cells multiply and grow. Usually, this medicine is taken twice a day for fourteen days. Then, patients do not take the pill for seven days. With this schedule and dose, some patients have had side effects that interfered with their comfort. We have used mathematical models to recommend a new schedule of capecitabine. In animals, 7 days of treatment with capecitabine followed by a 7-day break was safer and more active against breast cancer. The purpose of this study is to find out what effect (both good and bad) capecitabine has on you and your breast cancer when given in this new schedule and combined with lapatinib.

Background information
Other unique IDs: 
08-025

Upper Extremity Lymphatic Mapping for Breast Cancer Patients

Recruitment status: 
Recruiting

This study is being done to see if lymph nodes that drain the arm also drain the breast. An axillary lymph node dissection removes lymph nodes under the arm. It is done to help prevent cancer cells from spreading to the rest of the body. Usually, about 12 to 15 nodes are removed. They are then examined to see if they have cancer cells. Removing these lymph nodes has some side effects. The most common is lymphedema. This is the build-up of fluid in the arm. This study will tell us if it may be possible in the future to identify lymph nodes that just drain the arm. Leaving those nodes may help to reduce the rate of lymphedema for future patients.

Background information
Trial ID: 
NCT00717886
Other unique IDs: 
08-051
Official title: 

Upper Extremity Lymphatic Mapping for Breast Cancer Patients: A Pilot Study

Detailed description: 

 

Number to be enrolled: 
30 patients

Physical Activity Intervention for Lung Cancer Survivors

The purpose of this study is to learn how many lung cancer survivors will agree to a physical activity program. We also want to know if lung cancer survivors benefit from this program. This information will help us to develop our services for lung cancer survivors.

Background information
Other unique IDs: 
08-067

Cetuximab in Patients With Lung Adenocarcinoma Receiving Erlotinib That Have Developed "Acquired Resistance" to Erlotinib

Trial phase: 
Phase I
Recruitment status: 
Recruiting

The purpose of this study is to test if cetuximab (Erbitux) can shrink lung cancers that initially became smaller after taking erlotinib and then started to get bigger despite continuing treatment. Cetuximab is a medicine approved by the U.S. Food and Drug administration for treatment of head and neck and colon cancer. The goal of the phase I portion of this trial is to find out the highest dose of cetuximab that can be taken together with erlotinib. This study will also give an idea of how well cetuximab shrinks lung cancer when given with erlotinib. The purpose of this study is to test if cetuximab (Erbitux) can shrink lung cancers that initially became smaller after taking erlotinib or gefitinib and then started to get bigger despite continuing treatment. Cetuximab is a medicine approved by the U.S. Food and Drug administration for treatment of head and neck and colon cancer. The goal of this phase is to determine if cetuximab given with erlotinib causes lung cancers to shrink in size.

Background information
Trial ID: 
NCT00716456
Other unique IDs: 
08-055
Official title: 

A Phase I/II Trial of Cetuximab in Patients With Lung Adenocarcinoma Receiving Erlotinib That Have Developed "Acquired Resistance" to Erlotinib

Detailed description: 

 

Number to be enrolled: 
44 patients

Study Using Chemotherapy Followed by Intensity Modulated Radiation Therapy to the Pleura in Patients With Locally Advanced But Unresectable Malignant Pleural Mesothelioma

Trial phase: 
Phase II
Recruitment status: 
Recruiting

For patients with this type of cancer, the standard of care is treatment with chemotherapy. Radiation therapy is typically not used. This is because radiation to the entire lining of the lung has many side effects that are often severe including damage to the lung (pneumonitis). There is a new radiation technique using Intensity Modulated Radiation Therapy (IMRT) that has been shown to reduce many of the side effects of standard radiation therapy. This type of radiation therapy specifically targets the lining of the lung, where you have your cancer, and reduces the risk of damaging the lung itself. The purpose of this study is to test the safety and toxicity of standard chemotherapy followed by IMRT.

Background information
Trial ID: 
NCT00715611
Other unique IDs: 
08-053
Official title: 

Phase II Toxicity Study Using Chemotherapy Followed by Intensity Modulated Radiation Therapy to the Pleura in Patients With Locally Advanced But Unresectable Malignant Pleural Mesothelioma

Detailed description: 

 

Number to be enrolled: 
28 patients

Gemcitabine and Cisplatin (GC) Plus Sorafenib in Chemotherapy-naïve Patients With Locally Advanced or Metastatic Urothelial Carcinoma

Trial phase: 
Phase II
Recruitment status: 
Recruiting

Standard chemotherapy drugs generally work by killing rapidly dividing cells in your body. Cancers cells are some of the most rapidly dividing cells and that is why chemotherapy can be effective in some patients. Gemcitabine and Cisplatin are an effective and standard drug combination used to treat locally advanced and metastatic urothelial cancer. However, these drugs do not shrink tumors in all patients and when they do, it is generally for a limited amount of time. This has led scientists to look for different ways to treat cancer. New drugs have been developed to treat cancer that work differently than standard chemotherapy drugs. These drugs attempt to decrease the blood supply to tumors. By doing so, this may limit the tumor's source of oxygen and nutrients and prevent the tumor from growing. Sorafenib is an example of a drug that works in this way. In some patients with advanced kidney cancer, sorafenib alone has been shown to slow the progression of their disease. The purpose of this study is to find out what effects, good and/or bad, the combination of gemcitabine, cisplatin, and sorafenib has on you and your cancer.

Background information
Trial ID: 
NCT00714948
Other unique IDs: 
07-168
Official title: 

Phase II Study of Gemcitabine and Cisplatin (GC) Plus Sorafenib in Chemotherapy-naïve Patients With Locally Advanced or Metastatic Urothelial Carcinoma

Detailed description: 

 

Number to be enrolled: 
39 patients

Docetaxel + Cetuximab + Concurrent Re-Irradiation (Intensity - Modulated Radiation Therapy, IMRT) for Patients With Locoregionally Recurrent Head and Neck Cancer

This is a study for patients who have head and neck cancer that has recurred in the body area where they previously received radiation, and for whom surgery is not planned. A widely accepted treatment option in this situation is chemotherapy alone. Another approach that has been used in clinical trials is to treat patients with a repeat course of radiation. In these studies, some patients received chemotherapy at the same time as the radiation. In this clinical study, we wish to treat with radiation plus two drugs during the course of reirradiation, Taxotere® (docetaxel) and Erbitux® (cetuximab). Docetaxel and cetuximab both are chemotherapy drugs which are administered by vein. Both drugs help radiation kill cancer cells. The radiation will be administered using a strategy called intensity-modulated radiation therapy (IMRT), which focuses the radiation beam on the tumor. Docetaxel and cetuximab are both approved for the treatment of patients with head and neck cancer. However, the combination of radiation + docetaxel + cetuximab for patients with recurrent head and neck cancer is considered to be a topic for clinical research. The purpose of this study is to determine the good and bad effects of treatment with radiation + docetaxel + cetuximab.

Background information
Other unique IDs: 
08-050
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