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|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00036842
Show 94 Study Locations
|Study Chair:||Tomasz M. Beer, MD||OHSU Knight Cancer Institute|