Metastatic Cancer Clinical Trial
Official title:
Phase II Study, Multicenter, Open-label, Evaluating Efficacy of Treatment With Sutent® (Sunitinib) in Patients With Previously Untreated or Recurrent Brain Metastases Originating From Renal Cancer
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
kidney cancer that has spread to the brain.
OBJECTIVES:
Primary
- Determine the objective response rate in the brain after 2 courses of sunitnib malate
in patients with previously untreated or recurrent brain metastases secondary to renal
cancer following radiotherapy or surgery.
Secondary
- Evaluate duration of response.
- Evaluate objective response of non-CNS targets.
- Evaluate time to disease progression.
- Evaluate overall and progression-free survival.
- Evaluate neurological symptoms associated with the tumor.
- Evaluate feasibility and overall tolerance of this drug.
OUTLINE: This is a multicenter study.
Patients receive oral sunitinib malate once daily for 4 weeks. Courses repeat every 6 weeks
in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 6 months.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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