Sunitinib in Treating Patients With Kidney Cancer That Has Spread to the Brain
- Registration Number
- NCT00814021
- Lead Sponsor
- Institut Claudius Regaud
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description sunitinib, sunitinib malate -
- Primary Outcome Measures
Name Time Method Objective response rate in the brain after 2 courses From beginning of treatment until 2 courses of treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Institut Claudius Regaud
🇫🇷Toulouse, France
Institut Claudius Regaud🇫🇷Toulouse, France