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

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 metastatic germ cell tumors that have relapsed or not responded to treatment.

OBJECTIVES:

Primary

* Determine the efficacy of sunitinib malate in patients with refractory or relapsed metastatic germ cell tumors.

Secondary

* Determine the safety of this drug in these patients.
* Determine the time to tumor response and duration of tumor response in patients treated with this drug.

OUTLINE: This is a open-label study.

Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed at 28 days and then periodically thereafter.

Eligibility Criteria:
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