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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Kidney Cancer, Metastatic Cancer

Intervention / Treatment
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* Drug: sunitinib malate


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed adenocarcinoma of the kidney Metastatic disease Measurable disease by RECIST criteria Presence of previously untreated or recurrent brain metastases following radiotherapy or surgery No brain metastasis revealed by hemorrhage No single brain metastasis < 2 cm that is accessible by surgery or radiosurgery PATIENT CHARACTERISTICS: WHO performance status 0-2 (unless paresis due to brain metastases) ANC > 1,500/mm^3 Platelet count > 100,000/mm^3 Hemoglobin > 8 g/dL PT or INR < 1.5 times upper limit of normal (ULN) AST/ALT < 2.5 times ULN (< 5 times ULN in the case of liver metastases) Total bilirubin < 1.5 times ULN Serum creatinine < 200 μmol/L Not pregnant or nursing Fertile patients must use effective contraception during and for up to 30 days following completion of study treatment No other cancer except for in situ cervical cancer, curatively treated basal cell carcinoma of the skin, or other curatively treated cancer without evidence of recurrence within the past 5 years No uncontrolled hypertension (systolic BP ≥ 160 mm Hg and/or diastolic BP ≥ 90 mm Hg) None of the following cardiac conditions within the past 6 months: Significant cardiovascular disease NYHA class III-IV congestive heart failure Myocardial infarction Unstable angina Severe arrhythmia Cerebrovascular accident Severe thromboembolism No serious neuropsychiatric disease No psychological, familial, social, or geographic situations that preclude clinical follow-up No patient deprived of liberty by a court or administrative order Able to understand French PRIOR CONCURRENT THERAPY: At least 6 months since prior antineoplastic treatment with sunitinib malate At least 4 weeks since other prior treatment At least 3 weeks since prior hematopoietic growth factors (i.e., filgrastim [G-CSF] or sargramostim [GM-CSF]) No concurrent antivitamin K at curative or anticoagulation doses

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sunitinib,<br> | Drug: sunitinib malate<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate in the brain after 2 courses |  | From beginning of treatment until 2 courses of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent renal cell cancer, stage IV renal cell cancer, tumors metastatic to brain