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

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: National Cancer Institute (NCI); Pfizer
• Treatments: Sunitinib

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