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.
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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
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