sunitinib in treating patients with kidney cancer that has spread to the brain

Conditions: Kidney Cancer; Metastatic Cancer

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.

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.

Eligibility criteria:
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

Keywords: recurrent renal cell cancer stage iv renal cell cancer tumors metastatic to brain