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Extragonadal Germ Cell TumorPhase 2NCT00036842

Arsenic Trioxide in Treating Men With Germ Cell Cancer

A Phase 2 study testing arsenic trioxide in people with Extragonadal Germ Cell Tumor and Testicular Germ Cell Tumor, run by SWOG Cancer Research Network at 94 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 years and older, men only
What is being tested?
arsenic trioxide
How many people
Not given
Where
94 sitesUnited States
Study dates
Apr 2002to Jun 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

94 sites in 1 country.

94 sites in 1 country

United States94 sites

  • Veterans Affairs Medical Center - Albuquerque

    Albuquerque, New Mexico, 87108-5138

  • MBCCOP - University of New Mexico HSC

    Albuquerque, New Mexico, 87131

  • Harrington Cancer Center

    Amarillo, Texas, 79106

  • Texas Tech University Health Sciences Center School of Medicine

    Amarillo, Texas, 79106

  • Veterans Affairs Medical Center - Amarillo

    Amarillo, Texas, 79106

  • Veterans Affairs Medical Center - Ann Arbor

    Ann Arbor, Michigan, 48105

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0330

  • CCOP - Atlanta Regional

    Atlanta, Georgia, 30342-1701

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

    Aurora, Colorado, 80010

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Cancer Research Center at Boston Medical Center

    Boston, Massachusetts, 02118

  • Western New York Urology Associates

    Buffalo, New York, 14220

  • Veterans Affairs Medical Center - Charleston

    Charleston, South Carolina, 29401-5799

  • Hollings Cancer Center at Medical University of South Carolina

    Charleston, South Carolina, 29425

  • MBCCOP - University of Illinois at Chicago

    Chicago, Illinois, 60612

  • Veterans Affairs Medical Center - Chicago (Westside Hospital)

    Chicago, Illinois, 60612

  • Veterans Affairs Medical Center - Cincinnati

    Cincinnati, Ohio, 45220-2288

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45267-0501

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195-9001

  • CCOP - Columbus

    Columbus, Ohio, 43206

  • Veterans Affairs Medical Center - Dayton

    Dayton, Ohio, 45428-1002

  • CCOP - Dayton

    Dayton, Ohio, 45429

  • CCOP - Central Illinois

    Decatur, Illinois, 62526

  • Veterans Affairs Medical Center - Denver

    Denver, Colorado, 80220

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • Veterans Affairs Medical Center - Detroit

    Detroit, Michigan, 48201-1932

  • Josephine Ford Cancer Center at Henry Ford Hospital

    Detroit, Michigan, 48202

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010-3000

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234-6200

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0565

  • CCOP - Southeast Cancer Control Consortium

    Goldsboro, North Carolina, 27534-9479

  • CCOP - Grand Rapids

    Grand Rapids, Michigan, 49503

  • CCOP - Greenville

    Greenville, South Carolina, 29615

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

    Hines, Illinois, 60141

  • MBCCOP - Hawaii

    Honolulu, Hawaii, 96813

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030-4095

  • Baylor College of Medicine

    Houston, Texas, 77030

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216-4505

  • Veterans Affairs Medical Center - Jackson

    Jackson, Mississippi, 39216

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

    Kansas City, Kansas, 66160-7390

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Veterans Affairs Medical Center - Lexington

    Lexington, Kentucky, 40502-2236

  • Markey Cancer Center at University of Kentucky Chandler Medical Center

    Lexington, Kentucky, 40536-0084

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Veterans Affairs Medical Center - Little Rock

    Little Rock, Arkansas, 72205

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90033

  • Veterans Affairs Medical Center - West Los Angeles

    Los Angeles, California, 90073

  • Southwest Cancer and Research Center at University Medical Center

    Lubbock, Texas, 79415-3364

  • Veterans Affairs Outpatient Clinic - Martinez

    Martinez, California, 94553

  • Cardinal Bernardin Cancer Center at Loyola University Medical Center

    Maywood, Illinois, 60153-5500

  • University of Tennessee Cancer Institute

    Memphis, Tennessee, 38104

  • MBCCOP - Gulf Coast

    Mobile, Alabama, 36607

  • MBCCOP - LSU Health Sciences Center

    New Orleans, Louisiana, 70112

  • Tulane Cancer Center at Tulane University Hospital and Clinic

    New Orleans, Louisiana, 70112

  • Veterans Affairs Medical Center - New Orleans

    New Orleans, Louisiana, 70112

  • NYU School of Medicine's Kaplan Comprehensive Cancer Center

    New York, New York, 10016

  • Herbert Irving Comprehensive Cancer Center at Columbia University

    New York, New York, 10032

  • Sentara Cancer Institute at Sentara Norfolk General Hospital

    Norfolk, Virginia, 23510-1115

  • CCOP - Bay Area Tumor Institute

    Oakland, California, 94609-3305

  • Oklahoma University Medical Center

    Oklahoma City, Oklahoma, 73104

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

    Orange, California, 92868

  • CCOP - Western Regional, Arizona

    Phoenix, Arizona, 85006-2726

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

    Phoenix, Arizona, 85012

  • Cancer Institute at Oregon Health and Science University

    Portland, Oregon, 97201-3098

  • Veterans Affairs Medical Center - Portland

    Portland, Oregon, 97207

  • CCOP - Columbia River Oncology Program

    Portland, Oregon, 97225

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

    Rochester, New York, 14642

  • CCOP - Beaumont

    Royal Oak, Michigan, 48073-6769

  • University of California Davis Cancer Center

    Sacramento, California, 95817

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84132

  • Veterans Affairs Medical Center - Salt Lake City

    Salt Lake City, Utah, 84148

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229-3900

  • Veterans Affairs Medical Center - San Antonio (Murphy)

    San Antonio, Texas, 78229

  • CCOP - Santa Rosa Memorial Hospital

    Santa Rosa, California, 95403

  • CCOP - Virginia Mason Research Center

    Seattle, Washington, 98101

  • Veterans Affairs Medical Center - Seattle

    Seattle, Washington, 98108

  • Puget Sound Oncology Consortium

    Seattle, Washington, 98109

  • Veterans Affairs Medical Center - Shreveport

    Shreveport, Louisiana, 71101-4295

  • Louisiana State University Health Sciences Center - Shreveport

    Shreveport, Louisiana, 71130-3932

  • Providence Cancer Institute at Providence Hospital

    Southfield, Michigan, 48075

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29303

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri, 65807

  • St. Louis University Hospital Cancer Center

    St Louis, Missouri, 63110

  • CCOP - St. Louis-Cape Girardeau

    St Louis, Missouri, 63141

  • CCOP - Northwest

    Tacoma, Washington, 98405-0986

  • Veterans Affairs Medical Center - Tampa (Haley)

    Tampa, Florida, 33612

  • Veterans Affairs Medical Center - Temple

    Temple, Texas, 76504

  • CCOP - Scott and White Hospital

    Temple, Texas, 76508

  • Veterans Affairs Medical Center - Tucson

    Tucson, Arizona, 85723

  • Arizona Cancer Center at University of Arizona Health Sciences Center

    Tucson, Arizona, 85724

  • MBCCOP - Howard University Cancer Center

    Washington D.C., District of Columbia, 20060

  • CCOP - Wichita

    Wichita, Kansas, 67214-3882

  • Veterans Affairs Medical Center - Wichita

    Wichita, Kansas, 67218

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
arsenic trioxide
Keywords
recurrent malignant testicular germ cell tumor, extragonadal germ cell tumor
Medical subject headings
Testicular Germ Cell Tumor, Testicular Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • arsenic trioxideDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startApr 2002
  3. Study completionJun 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
IDs, dates and publications
ClinicalTrials.gov ID
NCT00036842
Sponsor's protocol ID
CDR0000069328
Other IDs
SWOG-S0207
Status last verified
Aug 2004
First submitted
13 May 2002
Last updated
24 Jun 2013
Results posted
No

Publications

  • 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.

    PubMed 16688776

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing arsenic trioxide in people with Extragonadal Germ Cell Tumor and Testicular Germ Cell Tumor, run by SWOG Cancer Research Network at 94 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 94 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00036842, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2013.

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