Arsenic Trioxide in Treating Men With Germ Cell Cancer
|ClinicalTrials.gov Identifier: NCT00036842|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 24, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Extragonadal Germ Cell Tumor Testicular Germ Cell Tumor||Drug: arsenic trioxide||Phase 2|
- 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 (Clinical Trial)|
|Official Title:||Phase II Study Of Arsenic Trioxide In Patients With Refractory Germ Cell Malignancies|
|Study Start Date :||April 2002|
|Study Completion Date :||June 2007|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00036842
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|Study Chair:||Tomasz M. Beer, MD||OHSU Knight Cancer Institute|