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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00814021
Study type Interventional
Source Institut Claudius Regaud
Contact
Status Completed
Phase Phase 2
Start date April 2009
Completion date March 2011

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