NCT00453310

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Extragonadal Germ Cell Tumor
• Ovarian Cancer
• Teratoma
• Testicular Germ Cell Tumor

Interventions

Type	Name	Description
DRUG	sunitinib malate

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-11-01
• Completion: 2008-11-01
• First posted: 2007-03-28
• Last updated: 2015-10-27
• Results posted: 2015-10-27

Locations

1 site across 1 country: United States