Sunitinib in Treating Patients With Brain Metastases Caused by Kidney Cancer or Melanoma
|ClinicalTrials.gov Identifier: NCT00462982|
Recruitment Status : Completed
First Posted : April 19, 2007
Results First Posted : December 30, 2015
Last Update Posted : December 30, 2015
RATIONALE: Sunitinib 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.
PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with brain metastases caused by kidney cancer or melanoma.
|Condition or disease||Intervention/treatment||Phase|
|Kidney Cancer Melanoma (Skin) Metastatic Cancer||Drug: sunitinib malate||Phase 2|
- Determine the efficacy of sunitinib malate, in terms of objective radiographic response of brain lesions, in patients with brain metastases secondary to renal cell carcinoma or melanoma.
- Determine overall and progression-free survival.
OUTLINE: Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed periodically.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of SU11248 (Sunitinib) in Patients With Renal Cell Carcinoma and Melanoma Metastatic to the Brain|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||August 2008|
|Actual Study Completion Date :||August 2008|
Patients will be treated with 50 mg daily for four out of every six weeks.
|Drug: sunitinib malate|
- Central Nervous System (CNS) Response Rate by RECIST Criteria [ Time Frame: up to a year ]Response and progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in RECIST. Measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques (CT, MRI, X-ray) or as >10 mm with spiral CT scan. This study will use a minimum diameter of 10 mm for measurable lesions in the brain, regardless of imaging modality. All tumor measurements must be recorded in millimeters (or decimal fractions of centimeters). All other lesions are considered non-measurable disease. Bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusions, inflammatory breast disease, and cystic lesions are all nonmeasurable.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00462982
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Principal Investigator:||Lauren E. Abrey, MD||Memorial Sloan Kettering Cancer Center|
|Principal Investigator:||Paul B. Chapman, MD||Memorial Sloan Kettering Cancer Center|
|Principal Investigator:||Robert J. Motzer, MD||Memorial Sloan Kettering Cancer Center|