Sunitinib in Treating Patients With Metastatic Germ Cell Tumors That Have Relapsed or Not Responded to Treatment

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed seminoma or nonseminoma germ cell tumors (GCT)
• * Refractory or relapsed disease
• * Metastatic disease
• Progressive disease after prior cisplatin-based chemotherapy AND meets 1 of the following criteria for salvage therapy:
• * Not a candidate for potentially curative therapy
• * Received prior high-dose chemotherapy regimens
• * Declines potentially curative therapy (mediastinal GCT or primary refractory GCT)
• Measurable disease\*, defined as 1 of the following:
• * At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
• * Elevation of alpha-fetoprotein \> 15 ng/mL and/or elevation of human chorionic gonadotropin \> 2.2 mIU/L
• NOTE: \*Patients with radiographically measurable disease only must have ≥ 1 site that has not undergone prior irradiation
• PATIENT CHARACTERISTICS:
• Karnofsky performance status 70-100%
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 9.0 g/dL
• Creatinine ≤ 1.5 times upper limit of normal (ULN)
• Bilirubin ≤ 1.5 times ULN
• AST and ALT ≤ 2.5 times ULN (unless elevated liver function abnormalities due to underlying malignancy)
• LVEF ≥ 50% by MUGA
• No grade 3 hemorrhage within the past 4 weeks
• None of the following within the past 6 months:
• * Myocardial infarction
• * Severe or unstable angina
• * Coronary or peripheral artery bypass graft
• * Symptomatic congestive heart failure
• * Cerebrovascular accident or transient ischemic attack
• * Pulmonary embolism
• No prolonged QTc interval (i.e., QTc \> 450 msec for males and \> 470 msec for females)
• No ongoing cardiac dysrhythmias ≥ grade 2
• No uncontrolled hypertension, defined as blood pressure \> 150/100 mm Hg despite optimal therapy
• No active infection
• No other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would preclude study compliance, according to the study investigator
• Not pregnant or nursing
• * Negative sonogram required to exclude pregnancy
• Fertile patients must use effective contraception
• PRIOR CONCURRENT THERAPY:
• See Disease Characteristics
• No prior sunitinib malate
• More than 4 weeks since prior major surgery and recovered
• More than 4 weeks since prior radiotherapy and recovered
• Concurrent palliative radiotherapy to metastatic lesion(s) allowed provided ≥ 1 measurable lesion has not been irradiated
• No concurrent therapeutic doses of warfarin
• * Low-dose oral warfarin (up to 2 mg daily) for prophylaxis and treatment or heparin products at prophylactic or treatment doses allowed
• No other concurrent investigational or approved anticancer therapies, including chemotherapy, biologic response modifiers, hormone therapy, or immunologic-based treatment
• * Concurrent participation in supportive care or nontreatment trials (e.g., quality-of-life or laboratory analyses) allowed