NCT00006043

Temozolomide in Treating Patients With Metastatic Germ Cell Tumors That Have Not Responded to Cisplatin

Phase II Trial of Temozolomide in Patients With Cisplatin-Refractory Germ Cell Tumors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have metastatic germ cell tumors that have not responded to cisplatin.

Detailed description

OBJECTIVES: I. Determine the efficacy of temozolomide in patients with cisplatin refractory metastatic germ cell tumors. II. Determine the safety of this treatment in these patients. OUTLINE: Patients receive oral temozolomide on days 1-5. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study over 25 months.

Conditions

• Ovarian Cancer
• Testicular Germ Cell Tumor

Interventions

Type	Name	Description
DRUG	temozolomide

Timeline

• Start date: 2000-02-01
• Primary completion: 2001-11-01
• Completion: 2001-11-01
• First posted: 2004-04-02
• Last updated: 2013-06-05

Locations

1 site across 1 country: United States