Arsenic Trioxide in Treating Men With Germ Cell Cancer

June 21, 2013 updated by: Southwest Oncology Group

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36607
        • MBCCOP - Gulf Coast
    • Arizona
      • Phoenix, Arizona, United States, 85006-2726
        • CCOP - Western Regional, Arizona
      • Phoenix, Arizona, United States, 85012
        • Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
      • Tucson, Arizona, United States, 85723
        • Veterans Affairs Medical Center - Tucson
      • Tucson, Arizona, United States, 85724
        • Arizona Cancer Center at University of Arizona Health Sciences Center
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
      • Little Rock, Arkansas, United States, 72205
        • Veterans Affairs Medical Center - Little Rock
    • California
      • Duarte, California, United States, 91010-3000
        • City of Hope Comprehensive Cancer Center
      • Los Angeles, California, United States, 90033
        • USC/Norris Comprehensive Cancer Center and Hospital
      • Los Angeles, California, United States, 90073
        • Veterans Affairs Medical Center - West Los Angeles
      • Martinez, California, United States, 94553
        • Veterans Affairs Outpatient Clinic - Martinez
      • Oakland, California, United States, 94609-3305
        • CCOP - Bay Area Tumor Institute
      • Orange, California, United States, 92868
        • Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
      • Sacramento, California, United States, 95817
        • University of California Davis Cancer Center
      • Santa Rosa, California, United States, 95403
        • CCOP - Santa Rosa Memorial Hospital
    • Colorado
      • Aurora, Colorado, United States, 80010
        • University of Colorado Cancer Center at University of Colorado Health Sciences Center
      • Denver, Colorado, United States, 80220
        • Veterans Affairs Medical Center - Denver
    • District of Columbia
      • Washington, District of Columbia, United States, 20060
        • MBCCOP - Howard University Cancer Center
    • Florida
      • Tampa, Florida, United States, 33612
        • Veterans Affairs Medical Center - Tampa (Haley)
    • Georgia
      • Atlanta, Georgia, United States, 30342-1701
        • CCOP - Atlanta Regional
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • MBCCOP - Hawaii
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Veterans Affairs Medical Center - Chicago (Westside Hospital)
      • Chicago, Illinois, United States, 60612
        • MBCCOP - University of Illinois at Chicago
      • Decatur, Illinois, United States, 62526
        • CCOP - Central Illinois
      • Hines, Illinois, United States, 60141
        • Veterans Affairs Medical Center - Hines (Edward Hines, Junior Hospital)
      • Maywood, Illinois, United States, 60153-5500
        • Cardinal Bernardin Cancer Center at Loyola University Medical Center
    • Kansas
      • Kansas City, Kansas, United States, 66160-7390
        • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
      • Wichita, Kansas, United States, 67214-3882
        • CCOP - Wichita
      • Wichita, Kansas, United States, 67218
        • Veterans Affairs Medical Center - Wichita
    • Kentucky
      • Lexington, Kentucky, United States, 40502-2236
        • Veterans Affairs Medical Center - Lexington
      • Lexington, Kentucky, United States, 40536-0084
        • Markey Cancer Center at University of Kentucky Chandler Medical Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Veterans Affairs Medical Center - New Orleans
      • New Orleans, Louisiana, United States, 70112
        • MBCCOP - LSU Health Sciences Center
      • New Orleans, Louisiana, United States, 70112
        • Tulane Cancer Center at Tulane University Hospital and Clinic
      • Shreveport, Louisiana, United States, 71130-3932
        • Louisiana State University Health Sciences Center - Shreveport
      • Shreveport, Louisiana, United States, 71101-4295
        • Veterans Affairs Medical Center - Shreveport
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Cancer Research Center at Boston Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • Veterans Affairs Medical Center - Ann Arbor
      • Ann Arbor, Michigan, United States, 48106
        • CCOP - Michigan Cancer Research Consortium
      • Ann Arbor, Michigan, United States, 48109-0330
        • University of Michigan Comprehensive Cancer Center
      • Detroit, Michigan, United States, 48202
        • Josephine Ford Cancer Center at Henry Ford Hospital
      • Detroit, Michigan, United States, 48201-1379
        • Barbara Ann Karmanos Cancer Institute
      • Detroit, Michigan, United States, 48201-1932
        • Veterans Affairs Medical Center - Detroit
      • Grand Rapids, Michigan, United States, 49503
        • CCOP - Grand Rapids
      • Royal Oak, Michigan, United States, 48073-6769
        • CCOP - Beaumont
      • Southfield, Michigan, United States, 48075
        • Providence Cancer Institute at Providence Hospital
    • Mississippi
      • Jackson, Mississippi, United States, 39216-4505
        • University of Mississippi Medical Center
      • Jackson, Mississippi, United States, 39216
        • Veterans Affairs Medical Center - Jackson
    • Missouri
      • Kansas City, Missouri, United States, 64131
        • CCOP - Kansas City
      • Saint Louis, Missouri, United States, 63141
        • CCOP - St. Louis-Cape Girardeau
      • Saint Louis, Missouri, United States, 63110
        • St. Louis University Hospital Cancer Center
      • Springfield, Missouri, United States, 65807
        • CCOP - Cancer Research for the Ozarks
    • Montana
      • Billings, Montana, United States, 59101
        • CCOP - Montana Cancer Consortium
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108-5138
        • Veterans Affairs Medical Center - Albuquerque
      • Albuquerque, New Mexico, United States, 87131
        • MBCCOP - University of New Mexico HSC
    • New York
      • Buffalo, New York, United States, 14220
        • Western New York Urology Associates
      • New York, New York, United States, 10016
        • NYU School of Medicine's Kaplan Comprehensive Cancer Center
      • New York, New York, United States, 10032
        • Herbert Irving Comprehensive Cancer Center at Columbia University
      • Rochester, New York, United States, 14642
        • James P. Wilmot Cancer Center at University of Rochester Medical Center
    • North Carolina
      • Goldsboro, North Carolina, United States, 27534-9479
        • CCOP - Southeast Cancer Control Consortium
    • Ohio
      • Cincinnati, Ohio, United States, 45220-2288
        • Veterans Affairs Medical Center - Cincinnati
      • Cincinnati, Ohio, United States, 45267-0501
        • Charles M. Barrett Cancer Center at University Hospital
      • Cleveland, Ohio, United States, 44195-9001
        • Cleveland Clinic Taussig Cancer Center
      • Columbus, Ohio, United States, 43206
        • CCOP - Columbus
      • Dayton, Ohio, United States, 45429
        • CCOP - Dayton
      • Dayton, Ohio, United States, 45428-1002
        • Veterans Affairs Medical Center - Dayton
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma University Medical center
    • Oregon
      • Portland, Oregon, United States, 97207
        • Veterans Affairs Medical Center - Portland
      • Portland, Oregon, United States, 97225
        • CCOP - Columbia River Oncology Program
      • Portland, Oregon, United States, 97201-3098
        • Cancer Institute at Oregon Health and Science University
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Hollings Cancer Center at Medical University of South Carolina
      • Charleston, South Carolina, United States, 29401-5799
        • Veterans Affairs Medical Center - Charleston
      • Greenville, South Carolina, United States, 29615
        • CCOP - Greenville
      • Spartanburg, South Carolina, United States, 29303
        • CCOP - Upstate Carolina
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • University of Tennessee Cancer Institute
    • Texas
      • Amarillo, Texas, United States, 79106
        • Texas Tech University Health Sciences Center School of Medicine
      • Amarillo, Texas, United States, 79106
        • Harrington Cancer Center
      • Amarillo, Texas, United States, 79106
        • Veterans Affairs Medical Center - Amarillo
      • Fort Sam Houston, Texas, United States, 78234-6200
        • Brooke Army Medical Center
      • Galveston, Texas, United States, 77555-0565
        • University of Texas Medical Branch
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Houston, Texas, United States, 77030-4095
        • University of Texas - MD Anderson Cancer Center
      • Lubbock, Texas, United States, 79415-3364
        • Southwest Cancer and Research Center at University Medical Center
      • San Antonio, Texas, United States, 78229-3900
        • University of Texas Health Science Center at San Antonio
      • San Antonio, Texas, United States, 78229
        • Veterans Affairs Medical Center - San Antonio (Murphy)
      • Temple, Texas, United States, 76504
        • Veterans Affairs Medical Center - Temple
      • Temple, Texas, United States, 76508
        • CCOP - Scott and White Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Huntsman Cancer Institute
      • Salt Lake City, Utah, United States, 84148
        • Veterans Affairs Medical Center - Salt Lake City
    • Virginia
      • Norfolk, Virginia, United States, 23510-1115
        • Sentara Cancer Institute at Sentara Norfolk General Hospital
    • Washington
      • Seattle, Washington, United States, 98101
        • CCOP - Virginia Mason Research Center
      • Seattle, Washington, United States, 98108
        • Veterans Affairs Medical Center - Seattle
      • Seattle, Washington, United States, 98109
        • Puget Sound Oncology Consortium
      • Tacoma, Washington, United States, 98405-0986
        • CCOP - Northwest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southwest Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Tomasz M. Beer, MD, OHSU Knight Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

May 13, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

June 24, 2013

Last Update Submitted That Met QC Criteria

June 21, 2013

Last Verified

August 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000069328
  • SWOG-S0207

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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