NCT00814021

Sunitinib in Treating Patients With Kidney Cancer That Has Spread to the Brain

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Institut Claudius Regaud · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Cancer
• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	sunitinib malate

Timeline

• Start date: 2009-04-01
• Primary completion: 2010-12-01
• Completion: 2011-03-01
• First posted: 2008-12-23
• Last updated: 2026-04-15

Locations

1 site across 1 country: France