Clinical trial · Interventional
Sunitinib in Treating Patients With Metastatic Germ Cell Tumors That Have Relapsed or Not Responded to Treatment
A Phase II Study of Sunitinib in Patients With Refractory or Relapsed Germ Cell Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extragonadal Germ Cell Tumor | Extragonadal Germ Cell Tumor | ONTOLOGY_EXACT | 0.98 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Teratoma | Teratoma | ONTOLOGY_EXACT | 0.90 |
| Testicular Germ Cell Tumor | Testicular Germ Cell Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| sunitinib malate | Drug | Sunitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- sunitinib malate
- description
- 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)
- interventionNames
- Drug: sunitinib malate
Primary outcomes (1)
- measure
- Confirmed Objective Response Rate (Complete and Partial Response) as Measured by RECIST Criteria After 2 Courses of Treatment
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTFeldman DR, Turkula S, Ginsberg MS, Ishill N, Patil S, Carousso M, Bosl GJ, Motzer RJ. Phase II trial of sunitinib in patients with relapsed or refractory germ cell tumors. Invest New Drugs. 2010 Aug;28(4):523-8. doi: 10.1007/s10637-009-9280-2. Epub 2009 Jun 23. PMID 19547919