Metastatic Cancer Clinical Trial
Official title:
A Phase II Study of SU11248 (Sunitinib) in Patients With Renal Cell Carcinoma and Melanoma Metastatic to the Brain
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.
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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