Sunitinib in Treating Patients With Metastatic Germ Cell Tumors That Have Relapsed or Not Responded to Treatment
Condition: Extragonadal Germ Cell Tumor; Ovarian Cancer; Teratoma; Testicular Germ Cell Tumor
MeSH terms: Neoplasms; Neoplasms, Germ Cell and Embryonal; Teratoma; Testicular Neoplasms
Intervention: sunitinib malate
Intervention MeSH terms: Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: 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

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.
    

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