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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase II Study of Sunitinib in Patients With Refractory or Relapsed Germ Cell Tumors

Conditions
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Extragonadal Germ Cell Tumor, Ovarian Cancer, Teratoma, Testicular Germ Cell Tumor

Intervention / Treatment
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* Drug: sunitinib malate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sunitinib malate<br>The dose of sunitinib malate will be a continuous daily dose of 37.5 mg administered orally for 6 weeks. The cycle of therapy is 42 days (or 6 weeks) | Drug: sunitinib malate<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confirmed Objective Response Rate (Complete and Partial Response) as Measured by RECIST Criteria After 2 Courses of Treatment |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent ovarian germ cell tumor, stage IV ovarian germ cell tumor, ovarian choriocarcinoma, ovarian immature teratoma, ovarian mature teratoma, recurrent malignant testicular germ cell tumor, testicular choriocarcinoma, testicular seminoma, testicular yolk sac tumor, ovarian dysgerminoma, ovarian embryonal carcinoma, ovarian yolk sac tumor, ovarian monodermal and highly specialized teratoma, ovarian polyembryoma, stage III malignant testicular germ cell tumor, ovarian mixed germ cell tumor, testicular choriocarcinoma and embryonal carcinoma, testicular choriocarcinoma and seminoma, testicular choriocarcinoma and teratoma, testicular choriocarcinoma and yolk sac tumor, testicular embryonal carcinoma and seminoma, testicular embryonal carcinoma and teratoma with seminoma, testicular embryonal carcinoma and teratoma, testicular embryonal carcinoma and yolk sac tumor with seminoma, testicular embryonal carcinoma and yolk sac tumor, testicular yolk sac tumor and teratoma with seminoma, testicular yolk sac tumor and teratoma, testicular embryonal carcinoma, recurrent extragonadal non-seminomatous germ cell tumor, recurrent extragonadal seminoma, stage IV extragonadal non-seminomatous germ cell tumor, stage IV extragonadal seminoma, recurrent extragonadal germ cell tumor, testicular immature teratoma, testicular mature teratoma, adult teratoma