Clinical Trial: Arsenic Trioxide in Treating Men With Germ Cell Cancer
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase II Study Of Arsenic Trioxide In Patients With Refractory Germ Cell Malignancies
Brief 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 Summary:
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.
Sponsor: Southwest Oncology Group
Current Primary Outcome:
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: National Cancer Institute (NCI)
Dates:
Date Received: May 13, 2002
Date Started: April 2002
Date Completion:
Last Updated: June 21, 2013
Last Verified: August 2004
