Vaccine Therapy for Patients With Stage IV Melanoma

NCT ID: NCT00052156

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

670 participants

Study Classification

INTERVENTIONAL

Brief Summary

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This is a Phase III study in patients with melanoma that has spread to the lymph nodes and/or a distant organ, and who have had all of their cancer surgically removed. The purpose of this study is to evaluate the ability of the CancerVax™ vaccine to prevent or slow the recurrence of melanoma.

Detailed Description

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Conditions

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Malignant Melanoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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CancerVax vaccine (CANVAXIN)

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Must have Stage IV melanoma
* Must have had all clinically-detectable disease surgically removed
* Cannot be taking any medications, or undergoing any therapies which compromise the functioning of your immune system (ie. Some corticosteroids, and certain types of radiation therapy)
* Cannot have HIV or Hepatitis A, B, or C
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CancerVax Corporation

INDUSTRY

Sponsor Role lead

Locations

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Arizona Cancer Center

Tucson, Arizona, United States

Site Status

Central Arkansas Veterans Healthcare System

Little Rock, Arkansas, United States

Site Status

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Kaiser Permanente Medical Group

Anaheim, California, United States

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Cedars Sinai Comprehensive Cancer Center

Los Angeles, California, United States

Site Status

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

Site Status

Comprehensive Cancer Center at DRMC

Palm Springs, California, United States

Site Status

Kaiser Permanente Medical Group

Riverside, California, United States

Site Status

Kaiser Permanente Medical Group

San Diego, California, United States

Site Status

Sharp Hospital

San Diego, California, United States

Site Status

UCSF Cancer Center and Cancer Research Institute

San Francisco, California, United States

Site Status

University of Colorado Cancer Center

Aurora, Colorado, United States

Site Status

Lakeland Regional Cancer Center

Lakeland, Florida, United States

Site Status

Mt. Sinai Comprehensive Cancer Center

Miami, Florida, United States

Site Status

University of Miami

Miami, Florida, United States

Site Status

Florida Hospital Cancer Institute

Orlando, Florida, United States

Site Status

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Site Status

The Cancer Institute at Good Samaritan Medical Center

West Palm Beach, Florida, United States

Site Status

Loyola University Medical Center

Maywood, Illinois, United States

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OSF Saint Francis Medica Center

Peoria, Illinois, United States

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Wagner and Associates

Indianapolis, Indiana, United States

Site Status

James Graham Brown Cancer Center

Louisville, Kentucky, United States

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St. Agnes Healthcare

Baltimore, Maryland, United States

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Franklin Square Hospital Center

Baltimore, Maryland, United States

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Sidney Kimmel Comprehensive Cancer Center

Lutherville, Maryland, United States

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Boston Medical Center

Boston, Massachusetts, United States

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Spectrum Health - Butterworth Campus

Grand Rapids, Michigan, United States

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Ellis Fischel Cancer Center - Columbia

Columbia, Missouri, United States

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St. Louis University Health Sciences Center

St Louis, Missouri, United States

Site Status

The Cancer Cener at Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status

Medical Center of Princeton

Princeton, New Jersey, United States

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Millard Fillmore Hospital

Buffalo, New York, United States

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Roswell Park Cancer Institute

Buffalo, New York, United States

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Columbia Presbyterian Medical Center

New York, New York, United States

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Suny Health Science Center at Syracuse

Syracuse, New York, United States

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Lineberger Comprehensive Cancer Center, UNC

Chapel Hill, North Carolina, United States

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Wake Forest University

Winston-Salem, North Carolina, United States

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Christ Hospital

Cincinnati, Ohio, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, United States

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Dayton Clinical Oncology Group

Dayton, Ohio, United States

Site Status

St. Lukes Hospital Cancer Center

Bethlehem, Pennsylvania, United States

Site Status

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Lankenau Hospital

Wynnewood, Pennsylvania, United States

Site Status

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Site Status

UT Southwest Medical Center- Dallas

Dallas, Texas, United States

Site Status

University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Intermountain Health Care- Mckay-Dee Hospital

Ogden, Utah, United States

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Intermountain Health Care-LDS Hospital

Salt Lake City, Utah, United States

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University of Washington

Seattle, Washington, United States

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Northwest Medical Specialties

Tacoma, Washington, United States

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Royal Prince Alfred Hospital, Sydney

Sydney, New South Wales, Australia

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NSW Breast Cancer Institute

Westmead, New South Wales, Australia

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Princess Alexandra Hospital

Brisbane, Queensland, Australia

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Royal Adelaide Hospital

Adelaide, South Australia, Australia

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Peter MacCallum Cancer Center

Melbourne, Victoria, Australia

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The Alfred Hospital

Melbourne, Victoria, Australia

Site Status

INCA (National Cancer Institute)

Rio de Janeiro, , Brazil

Site Status

Hospital Sirio Lebanes

São Paulo, , Brazil

Site Status

McGill University

Montreal, Quebec, Canada

Site Status

CHU Pitie-Salpetriere

Paris, , France

Site Status

Klinikum Augsburg

Augsburg, , Germany

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Charite- University Medicine

Berlin, , Germany

Site Status

University of Jena

Jena, , Germany

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University Hospial of Mannheim

Mannheim, , Germany

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University of Tuebingen

Tübingen, , Germany

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University of Ulm

Ulm, , Germany

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University Hospital Wuerzburg

Würzburg, , Germany

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Cork University

Cork, , Ireland

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Tel-Aviv Medical Center

Tel Aviv, , Israel

Site Status

Istituto Nazionale Tumori di Milano

Milan, Milan, Italy

Site Status

Instituto Eurepeo di Oncologia

Milan, Milan, Italy

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Istituto Nazionale dei Tumori

Naples, , Italy

Site Status

University Hospital of Groningen

Groningen, , Netherlands

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North Shore Hospital

Auckland, Auckland, New Zealand

Site Status

University of Zurich

Zurich, , Switzerland

Site Status

Harley Street Clinic

London, England, United Kingdom

Site Status

Countries

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United States Australia Brazil Canada France Germany Ireland Israel Italy Netherlands New Zealand Switzerland United Kingdom

References

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Faries MB, Mozzillo N, Kashani-Sabet M, Thompson JF, Kelley MC, DeConti RC, Lee JE, Huth JF, Wagner J, Dalgleish A, Pertschuk D, Nardo C, Stern S, Elashoff R, Gammon G, Morton DL; MMAIT-IV Clinical Trial Group. Long-Term Survival after Complete Surgical Resection and Adjuvant Immunotherapy for Distant Melanoma Metastases. Ann Surg Oncol. 2017 Dec;24(13):3991-4000. doi: 10.1245/s10434-017-6072-3. Epub 2017 Oct 10.

Reference Type DERIVED
PMID: 29019177 (View on PubMed)

Hoshimoto S, Faries MB, Morton DL, Shingai T, Kuo C, Wang HJ, Elashoff R, Mozzillo N, Kelley MC, Thompson JF, Lee JE, Hoon DS. Assessment of prognostic circulating tumor cells in a phase III trial of adjuvant immunotherapy after complete resection of stage IV melanoma. Ann Surg. 2012 Feb;255(2):357-62. doi: 10.1097/SLA.0b013e3182380f56.

Reference Type DERIVED
PMID: 22202581 (View on PubMed)

Related Links

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http://www.cancervax.com

CancerVax Corporation Website

Other Identifiers

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JWCI-MC-4-001

Identifier Type: -

Identifier Source: secondary_id

CV-MMAIT-4-001

Identifier Type: -

Identifier Source: org_study_id

NCT00003722

Identifier Type: -

Identifier Source: nct_alias