Testicular Germ Cell Tumor Clinical Trial
Official title:
Phase II Study Of Arsenic Trioxide In Patients With Refractory Germ Cell Malignancies
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.
;
Primary Purpose: Treatment
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