NCT00036842

Arsenic Trioxide in Treating Men With Germ Cell Cancer

Phase II Study Of Arsenic Trioxide In Patients With Refractory Germ Cell Malignancies

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: SWOG Cancer Research Network · Network
• Sex: Male
• 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 arsenic trioxide in treating men who have germ cell cancer that has not responded to previous treatment.

Detailed description

OBJECTIVES: * Determine the response rate (confirmed complete and partial responses) in men with refractory testicular or extragonadal germ cell malignancies treated with arsenic trioxide. * Determine the overall and progression-free survival of patients treated with this drug. * Determine the qualitative and quantitative toxic effects of this drug in these patients. * Assess the biomarker response rate in patients with elevated biomarkers treated with this drug. OUTLINE: This is a multicenter study. Patients receive arsenic trioxide IV over 1-2 hours on days 1-5. Courses repeat every 28 days for up to 3 years in the absence of disease progression or unacceptable toxicity. Patients who achieve a confirmed complete or partial response receive up to 3 additional courses past response. Patients are followed every 2 months for 3 years or until disease progression. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 10-40 months.

Conditions

• Extragonadal Germ Cell Tumor
• Testicular Germ Cell Tumor

Interventions

Type	Name	Description
DRUG	arsenic trioxide

Timeline

• Start date: 2002-04-01
• Completion: 2007-06-01
• First posted: 2003-01-27
• Last updated: 2013-06-24

Locations

94 sites across 1 country: United States