Arsenic Trioxide in Treating Men With Germ Cell Cancer
Extragonadal Germ Cell Tumor, Testicular Germ Cell Tumor
About this trial
This is an interventional treatment trial for Extragonadal Germ Cell Tumor focused on measuring recurrent malignant testicular germ cell tumor, extragonadal germ cell tumor
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed testicular or extragonadal germ cell cancer Refractory disease, defined by at least 1 of the following criteria: Disease progression during or within 4 weeks of cisplatin-containing regimen Progression is defined as the appearance of new or progression of known locally advanced or metastatic disease or a rise in tumor markers (beta-human chorionic gonadotropin (beta-HCG) or alpha fetoprotein (AFP)) by at least 50% relative to the nadir When the only evidence of germ cell progression or recurrence before study entry is the appearance of a new lesion in the absence of tumor marker elevation, a biopsy is required to confirm the diagnosis Disease recurrence after at least 2 chemotherapy regimens, one of which includes high-dose therapy (chemotherapy with stem cell support) Disease recurrence after at least 2 chemotherapy regimens and not eligible for high-dose therapy At least 1 of the following: Unidimensionally measurable disease Soft tissue, irradiated within the past 2 months, is not considered measurable Elevated beta-HCG (more than 20 mIU/mL) AFP greater than 2 times upper limit of normal PATIENT CHARACTERISTICS: Age: 16 and over Sex: Male Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 WBC at least 3,000/mm^3 Hepatic: Bilirubin less than 2.5 times upper limit of normal (ULN) SGOT less than 5 times ULN Alkaline phosphatase less than 5 times ULN Renal: Creatinine no greater than 2.5 times ULN OR Creatinine clearance at least 40 mL/min Potassium normal Magnesium normal No renal dialysis Cardiovascular: No prior torsades de pointes-type ventricular arrhythmia No prolonged QT interval (greater than 450 msec) on ECG in presence of normal potassium and magnesium Other: Fertile patients must use effective contraception No active serious infection not controlled by antibiotics No known hypersensitivity to arsenic No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or stage I or II disease in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics More than 28 days since prior cytotoxic agents Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 28 days since prior radiotherapy and recovered Surgery: Not specified Other: More than 28 days since prior experimental agents No concurrent or planned drugs known to prolong the QT interval
Sites / Locations
- MBCCOP - Gulf Coast
- CCOP - Western Regional, Arizona
- Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
- Veterans Affairs Medical Center - Tucson
- Arizona Cancer Center at University of Arizona Health Sciences Center
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- Veterans Affairs Medical Center - Little Rock
- City of Hope Comprehensive Cancer Center
- USC/Norris Comprehensive Cancer Center and Hospital
- Veterans Affairs Medical Center - West Los Angeles
- Veterans Affairs Outpatient Clinic - Martinez
- CCOP - Bay Area Tumor Institute
- Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
- University of California Davis Cancer Center
- CCOP - Santa Rosa Memorial Hospital
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
- Veterans Affairs Medical Center - Denver
- MBCCOP - Howard University Cancer Center
- Veterans Affairs Medical Center - Tampa (Haley)
- CCOP - Atlanta Regional
- MBCCOP - Hawaii
- MBCCOP - University of Illinois at Chicago
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
- CCOP - Central Illinois
- Veterans Affairs Medical Center - Hines (Edward Hines, Junior Hospital)
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
- CCOP - Wichita
- Veterans Affairs Medical Center - Wichita
- Veterans Affairs Medical Center - Lexington
- Markey Cancer Center at University of Kentucky Chandler Medical Center
- MBCCOP - LSU Health Sciences Center
- Tulane Cancer Center at Tulane University Hospital and Clinic
- Veterans Affairs Medical Center - New Orleans
- Veterans Affairs Medical Center - Shreveport
- Louisiana State University Health Sciences Center - Shreveport
- Cancer Research Center at Boston Medical Center
- Veterans Affairs Medical Center - Ann Arbor
- CCOP - Michigan Cancer Research Consortium
- University of Michigan Comprehensive Cancer Center
- Barbara Ann Karmanos Cancer Institute
- Veterans Affairs Medical Center - Detroit
- Josephine Ford Cancer Center at Henry Ford Hospital
- CCOP - Grand Rapids
- CCOP - Beaumont
- Providence Cancer Institute at Providence Hospital
- University of Mississippi Medical Center
- Veterans Affairs Medical Center - Jackson
- CCOP - Kansas City
- St. Louis University Hospital Cancer Center
- CCOP - St. Louis-Cape Girardeau
- CCOP - Cancer Research for the Ozarks
- CCOP - Montana Cancer Consortium
- Veterans Affairs Medical Center - Albuquerque
- MBCCOP - University of New Mexico HSC
- Western New York Urology Associates
- NYU School of Medicine's Kaplan Comprehensive Cancer Center
- Herbert Irving Comprehensive Cancer Center at Columbia University
- James P. Wilmot Cancer Center at University of Rochester Medical Center
- CCOP - Southeast Cancer Control Consortium
- Veterans Affairs Medical Center - Cincinnati
- Charles M. Barrett Cancer Center at University Hospital
- Cleveland Clinic Taussig Cancer Center
- CCOP - Columbus
- Veterans Affairs Medical Center - Dayton
- CCOP - Dayton
- Oklahoma University Medical Center
- Cancer Institute at Oregon Health and Science University
- Veterans Affairs Medical Center - Portland
- CCOP - Columbia River Oncology Program
- Veterans Affairs Medical Center - Charleston
- Hollings Cancer Center at Medical University of South Carolina
- CCOP - Greenville
- CCOP - Upstate Carolina
- University of Tennessee Cancer Institute
- Harrington Cancer Center
- Texas Tech University Health Sciences Center School of Medicine
- Veterans Affairs Medical Center - Amarillo
- Brooke Army Medical Center
- University of Texas Medical Branch
- University of Texas - MD Anderson Cancer Center
- Baylor College of Medicine
- Southwest Cancer and Research Center at University Medical Center
- University of Texas Health Science Center at San Antonio
- Veterans Affairs Medical Center - San Antonio (Murphy)
- Veterans Affairs Medical Center - Temple
- CCOP - Scott and White Hospital
- Huntsman Cancer Institute
- Veterans Affairs Medical Center - Salt Lake City
- Sentara Cancer Institute at Sentara Norfolk General Hospital
- CCOP - Virginia Mason Research Center
- Veterans Affairs Medical Center - Seattle
- Puget Sound Oncology Consortium
- CCOP - Northwest