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

Institut Claudius Regaud21 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Kidney Cancer Metastatic Cancer

Interventions

sunitinib malateDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Locations (1)

Institut Claudius Regaud

Toulouse, France

Outcomes

Primary Outcomes

Objective response rate in the brain after 2 courses

Time frame: From beginning of treatment until 2 courses of treatment

Data from ClinicalTrials.gov

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