Sunitinib in Treating Patients With Kidney Cancer That Has Spread to the Brain
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|ClinicalTrials.gov Identifier: NCT00814021|
Recruitment Status : Completed
First Posted : December 23, 2008
Last Update Posted : November 5, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Kidney Cancer Metastatic Cancer||Drug: sunitinib malate||Phase 2|
- 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.
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||March 2011|
|Experimental: sunitinib,||Drug: sunitinib malate|
- Objective response rate in the brain after 2 courses [ Time Frame: From beginning of treatment until 2 courses of treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00814021
|Institut Claudius Regaud|
|Toulouse, France, 31052|
|Study Chair:||Christine Chevreau-Dalbianco, MD||Institut Claudius Regaud|