Arsenic Trioxide in Treating Men With Germ Cell Cancer
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.
Extragonadal Germ Cell Tumor
Testicular Germ Cell Tumor
Drug: arsenic trioxide
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Study Of Arsenic Trioxide In Patients With Refractory Germ Cell Malignancies|
|Study Start Date:||April 2002|
- 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.