Sunitinib in Treating Patients With Brain Metastases Caused by Kidney Cancer or Melanoma
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.
Drug: sunitinib malate
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of SU11248 (Sunitinib) in Patients With Renal Cell Carcinoma and Melanoma Metastatic to the Brain|
- CNS response (complete and partial response) rate by RECIST criteria [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||March 2007|
|Study Completion Date:||August 2008|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
Patients will be treated with 50 mg daily for four out of every six weeks.
|Drug: sunitinib malate|
- 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.
|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|