Arsenic Trioxide in Treating Men With Germ Cell Cancer

NCT00036842 | Completed Phase 2

• 2 other identifiers: CDR0000069328SWOG-S0207
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 94

Brief Summary

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.

Conditions

Extragonadal Germ Cell Tumor; Testicular Germ Cell Tumor

Keywords

recurrent malignant testicular germ cell tumor; extragonadal germ cell tumor

Interventions

arsenic trioxide DRUG

Eligibility Criteria

• Age: 16 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator

Study Sites (94)

MBCCOP - Gulf Coast

Mobile, Alabama, 36607, United States

Location

CCOP - Western Regional, Arizona

Phoenix, Arizona, 85006-2726, United States

Location

Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)

Phoenix, Arizona, 85012, United States

Location

Veterans Affairs Medical Center - Tucson

Tucson, Arizona, 85723, United States

Location

Arizona Cancer Center at University of Arizona Health Sciences Center

Tucson, Arizona, 85724, United States

Location

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Veterans Affairs Medical Center - Little Rock

Little Rock, Arkansas, 72205, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90033, United States

Location

Veterans Affairs Medical Center - West Los Angeles

Los Angeles, California, 90073, United States

Location

Veterans Affairs Outpatient Clinic - Martinez

Martinez, California, 94553, United States

Location

CCOP - Bay Area Tumor Institute

Oakland, California, 94609-3305, United States

Location

Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center

Orange, California, 92868, United States

Location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

CCOP - Santa Rosa Memorial Hospital

Santa Rosa, California, 95403, United States

Location

University of Colorado Cancer Center at University of Colorado Health Sciences Center

Aurora, Colorado, 80010, United States

Location

Veterans Affairs Medical Center - Denver

Denver, Colorado, 80220, United States

Location

MBCCOP - Howard University Cancer Center

Washington D.C., District of Columbia, 20060, United States

Location

Veterans Affairs Medical Center - Tampa (Haley)

Tampa, Florida, 33612, United States

Location

CCOP - Atlanta Regional

Atlanta, Georgia, 30342-1701, United States

Location

MBCCOP - Hawaii

Honolulu, Hawaii, 96813, United States

Location

MBCCOP - University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Veterans Affairs Medical Center - Chicago (Westside Hospital)

Chicago, Illinois, 60612, United States

Location

CCOP - Central Illinois

Decatur, Illinois, 62526, United States

Location

Veterans Affairs Medical Center - Hines (Edward Hines, Junior Hospital)

Hines, Illinois, 60141, United States

Location

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, 60153-5500, United States

Location

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

Kansas City, Kansas, 66160-7390, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

Veterans Affairs Medical Center - Wichita

Wichita, Kansas, 67218, United States

Location

Veterans Affairs Medical Center - Lexington

Lexington, Kentucky, 40502-2236, United States

Location

Markey Cancer Center at University of Kentucky Chandler Medical Center

Lexington, Kentucky, 40536-0084, United States

Location

MBCCOP - LSU Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Tulane Cancer Center at Tulane University Hospital and Clinic

New Orleans, Louisiana, 70112, United States

Location

Veterans Affairs Medical Center - New Orleans

New Orleans, Louisiana, 70112, United States

Location

Veterans Affairs Medical Center - Shreveport

Shreveport, Louisiana, 71101-4295, United States

Location

Louisiana State University Health Sciences Center - Shreveport

Shreveport, Louisiana, 71130-3932, United States

Location

Cancer Research Center at Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Veterans Affairs Medical Center - Ann Arbor

Ann Arbor, Michigan, 48105, United States

Location

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, 48106, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0330, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Veterans Affairs Medical Center - Detroit

Detroit, Michigan, 48201-1932, United States

Location

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

CCOP - Grand Rapids

Grand Rapids, Michigan, 49503, United States

Location

CCOP - Beaumont

Royal Oak, Michigan, 48073-6769, United States

Location

Providence Cancer Institute at Providence Hospital

Southfield, Michigan, 48075, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216-4505, United States

Location

Veterans Affairs Medical Center - Jackson

Jackson, Mississippi, 39216, United States

Location

CCOP - Kansas City

Kansas City, Missouri, 64131, United States

Location

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, 65807, United States

Location

St. Louis University Hospital Cancer Center

St Louis, Missouri, 63110, United States

Location

CCOP - St. Louis-Cape Girardeau

St Louis, Missouri, 63141, United States

Location

CCOP - Montana Cancer Consortium

Billings, Montana, 59101, United States

Location

Veterans Affairs Medical Center - Albuquerque

Albuquerque, New Mexico, 87108-5138, United States

Location

MBCCOP - University of New Mexico HSC

Albuquerque, New Mexico, 87131, United States

Location

Western New York Urology Associates

Buffalo, New York, 14220, United States

Location

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, 10016, United States

Location

Herbert Irving Comprehensive Cancer Center at Columbia University

New York, New York, 10032, United States

Location

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

CCOP - Southeast Cancer Control Consortium

Goldsboro, North Carolina, 27534-9479, United States

Location

Veterans Affairs Medical Center - Cincinnati

Cincinnati, Ohio, 45220-2288, United States

Location

Charles M. Barrett Cancer Center at University Hospital

Cincinnati, Ohio, 45267-0501, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195-9001, United States

Location

CCOP - Columbus

Columbus, Ohio, 43206, United States

Location

Veterans Affairs Medical Center - Dayton

Dayton, Ohio, 45428-1002, United States

Location

CCOP - Dayton

Dayton, Ohio, 45429, United States

Location

Oklahoma University Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

Cancer Institute at Oregon Health and Science University

Portland, Oregon, 97201-3098, United States

Location

Veterans Affairs Medical Center - Portland

Portland, Oregon, 97207, United States

Location

CCOP - Columbia River Oncology Program

Portland, Oregon, 97225, United States

Location

Veterans Affairs Medical Center - Charleston

Charleston, South Carolina, 29401-5799, United States

Location

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

CCOP - Greenville

Greenville, South Carolina, 29615, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

University of Tennessee Cancer Institute

Memphis, Tennessee, 38104, United States

Location

Harrington Cancer Center

Amarillo, Texas, 79106, United States

Location

Texas Tech University Health Sciences Center School of Medicine

Amarillo, Texas, 79106, United States

Location

Veterans Affairs Medical Center - Amarillo

Amarillo, Texas, 79106, United States

Location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234-6200, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-0565, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4095, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Southwest Cancer and Research Center at University Medical Center

Lubbock, Texas, 79415-3364, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229-3900, United States

Location

Veterans Affairs Medical Center - San Antonio (Murphy)

San Antonio, Texas, 78229, United States

Location

Veterans Affairs Medical Center - Temple

Temple, Texas, 76504, United States

Location

CCOP - Scott and White Hospital

Temple, Texas, 76508, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84132, United States

Location

Veterans Affairs Medical Center - Salt Lake City

Salt Lake City, Utah, 84148, United States

Location

Sentara Cancer Institute at Sentara Norfolk General Hospital

Norfolk, Virginia, 23510-1115, United States

Location

CCOP - Virginia Mason Research Center

Seattle, Washington, 98101, United States

Location

Veterans Affairs Medical Center - Seattle

Seattle, Washington, 98108, United States

Location

Puget Sound Oncology Consortium

Seattle, Washington, 98109, United States

Location

CCOP - Northwest

Tacoma, Washington, 98405-0986, United States

Location

Related Publications (1)

• Beer TM, Tangen CM, Nichols CR, Margolin KA, Dreicer R, Stephenson WT, Quinn DI, Raghavan D, Crawford ED. Southwest Oncology Group phase II study of arsenic trioxide in patients with refractory germ cell malignancies. Cancer. 2006 Jun 15;106(12):2624-9. doi: 10.1002/cncr.21925.

  PMID: 16688776 RESULT

MeSH Terms

Conditions

Testicular Germ Cell Tumor; Testicular Neoplasms

Interventions

Arsenic Trioxide

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Arsenicals; Inorganic Chemicals; Oxides; Oxygen Compounds

Study Officials

• Tomasz M. Beer, MD

  OHSU Knight Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: May 13, 2002
• First Posted: January 27, 2003
• Study Start: April 1, 2002
• Study Completion: June 1, 2007
• Last Updated: June 24, 2013

Record last verified: 2004-08

Locations

US (94)