Vaccine Therapy for Patients With Stage IV Melanoma

June 23, 2005 updated by: CancerVax Corporation

A Phase III Randomized Double-Blind Pivotal Trial of Immunotherapy With a Polyvalent Melanoma Vaccine, CancerVax™ Vaccine Plus BCG Versus Placebo Plus BCG as a Post-Surgical Treatment for Stage IV Melanoma

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.

Study Overview

Status

Unknown

Conditions

Malignant Melanoma

Intervention / Treatment

Biological: CancerVax vaccine (CANVAXIN)

Study Type

Interventional

Enrollment

670

Phase

Phase 3

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

Australia
- New South Wales
  - Sydney, New South Wales, Australia, 2050
    - Royal Prince Alfred Hospital, Sydney
  - Westmead, New South Wales, Australia, 2145
    - NSW Breast Cancer Institute
- Queensland
  - Brisbane, Queensland, Australia, 4102
    - Princess Alexandra Hospital
- South Australia
  - Adelaide, South Australia, Australia, 5000
    - Royal Adelaide Hospital
- Victoria
  - Melbourne, Victoria, Australia, 3181
    - The Alfred Hospital
  - Melbourne, Victoria, Australia, 3002
    - Peter MacCallum Cancer Center
Brazil
- - Rio de Janeiro, Brazil, 20230
    - INCA (National Cancer Institute)
  - Sao Paulo, Brazil, 01308-050
    - Hospital Sirio Lebanes
Canada
- Quebec
  - Montreal, Quebec, Canada
    - McGill University
France
- - Paris, France, 75651
    - CHU Pitié-Salpétrière
Germany
- - Augsburg, Germany
    - Klinikum Augsburg
  - Berlin, Germany
    - Charite- University Medicine
  - Jena, Germany, 07740
    - University of Jena
  - Mannheim, Germany
    - University Hospial of Mannheim
  - Tuebingen, Germany
    - University of Tuebingen
  - Ulm, Germany
    - University of Ulm
  - Wuerzburg, Germany
    - University Hospital Wuerzburg
Ireland
- - Cork, Ireland
    - Cork University
Israel
- - Tel Aviv, Israel, 62995
    - Tel-Aviv Medical Center
Italy
- - Milan, Italy, 20133
    - Istituto Nazionale Tumori di Milano
  - Milan, Italy, 20141
    - Instituto Eurepeo di Oncologia
  - Naples, Italy, 80132
    - Istituto Nazionale Dei Tumori
Netherlands
- - Groningen, Netherlands
    - University Hospital of Groningen
New Zealand
- - Auckland, New Zealand, 92024
    - North Shore Hospital
Switzerland
- - Zurich, Switzerland
    - University of Zurich
United Kingdom
- England
  - London, England, United Kingdom, SW17 ORE
    - Harley Street Clinic
United States
- Arizona
  - Tucson, Arizona, United States, 85724
    - Arizona Cancer Center
- Arkansas
  - Little Rock, Arkansas, United States, 72205
    - University of Arkansas for Medical Sciences
  - Little Rock, Arkansas, United States, 72205
    - Central Arkansas Veterans Healthcare System
- California
  - Anaheim, California, United States
    - Kaiser Permanente Medical Group
  - Los Angeles, California, United States
    - Cedars Sinai Comprehensive Cancer Center
  - Newport Beach, California, United States, 92658
    - Hoag Memorial Hospital Presbyterian
  - Palm Springs, California, United States, 92262
    - Comprehensive Cancer Center at DRMC
  - Riverside, California, United States
    - Kaiser Permanente Medical Group
  - San Diego, California, United States, 92120
    - Kaiser Permanente Medical Group
  - San Diego, California, United States, 92123
    - Sharp Hospital
  - San Francisco, California, United States, 94143-0128
    - UCSF Cancer Center and Cancer Research Institute
- Colorado
  - Aurora, Colorado, United States
    - University of Colorado Cancer Center
- Florida
  - Lakeland, Florida, United States, 33805
    - Lakeland Regional Cancer Center
  - Miami, Florida, United States
    - University of Miami
  - Miami, Florida, United States
    - Mt. Sinai Comprehensive Cancer Center
  - Orlando, Florida, United States, 32804
    - Florida Hospital Cancer Institute
  - Tampa, Florida, United States, 33612-9497
    - H. Lee Moffitt Cancer Center and Research Institute
  - West Palm Beach, Florida, United States, 33401
    - The Cancer Institute at Good Samaritan Medical Center
- Illinois
  - Maywood, Illinois, United States
    - Loyola University Medical Center
  - Peoria, Illinois, United States, 61637
    - OSF Saint Francis Medica Center
- Indiana
  - Indianapolis, Indiana, United States, 46256
    - Wagner and Associates
- Kentucky
  - Louisville, Kentucky, United States, 40202
    - James Graham Brown Cancer Center
- Maryland
  - Baltimore, Maryland, United States, 21237
    - Franklin Square Hospital Center
  - Baltimore, Maryland, United States, 21229
    - St. Agnes Healthcare
  - Lutherville, Maryland, United States
    - Sidney Kimmel Comprehensive Cancer Center
- Massachusetts
  - Boston, Massachusetts, United States, 02118-2393
    - Boston Medical Center
- Michigan
  - Grand Rapids, Michigan, United States, 49546
    - Spectrum Health - Butterworth Campus
- Missouri
  - Columbia, Missouri, United States, 65203
    - Ellis Fischel Cancer Center - Columbia
  - Saint Louis, Missouri, United States, 63110-0250
    - St. Louis University Health Sciences Center
- New Jersey
  - Hackensack, New Jersey, United States, 07601
    - The Cancer Cener at Hackensack University Medical Center
  - Princeton, New Jersey, United States, 08540
    - Medical Center of Princeton
- New York
  - Buffalo, New York, United States, 14263-0001
    - Roswell Park Cancer Institute
  - Buffalo, New York, United States, 14209
    - Millard Fillmore Hospital
  - New York, New York, United States, 10032
    - Columbia Presbyterian Medical Center
  - Syracuse, New York, United States, 13210
    - Suny Health Science Center at Syracuse
- North Carolina
  - Chapel Hill, North Carolina, United States, 27599-7295
    - Lineberger Comprehensive Cancer Center, UNC
  - Winston Salem, North Carolina, United States
    - Wake Forest University
- Ohio
  - Cincinnati, Ohio, United States, 45219
    - Christ Hospital
  - Cleveland, Ohio, United States
    - Cleveland Clinic Foundation
  - Columbus, Ohio, United States, 43210-1240
    - Arthur G. James Cancer Hospital - Ohio State University
  - Dayton, Ohio, United States, 45409
    - Dayton Clinical Oncology Group
- Pennsylvania
  - Bethlehem, Pennsylvania, United States, 18015
    - St. Lukes Hospital Cancer Center
  - Philadelphia, Pennsylvania, United States, 19104-4283
    - University of Pennsylvania Cancer Center
  - Wynnewood, Pennsylvania, United States, 19096
    - Lankenau Hospital
- Tennessee
  - Nashville, Tennessee, United States, 37232-6838
    - Vanderbilt-Ingram Cancer Center
- Texas
  - Dallas, Texas, United States, 75235-9154
    - UT Southwest Medical Center- Dallas
  - Houston, Texas, United States, 77030-4009
    - University of Texas - MD Anderson Cancer Center
- Utah
  - Ogden, Utah, United States, 84403
    - Intermountain Health Care- Mckay-Dee Hospital
  - Salt Lake City, Utah, United States, 84143
    - Intermountain Health Care-LDS Hospital
- Washington
  - Seattle, Washington, United States, 98109
    - University of Washington
  - Tacoma, Washington, United States, 98405
    - Northwest Medical Specialties

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

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
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Collaborators and Investigators

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

Sponsor

CancerVax Corporation

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

Helpful Links

CancerVax Corporation Website

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 Registration Dates

First Submitted

January 23, 2003

First Submitted That Met QC Criteria

January 23, 2003

First Posted (Estimate)

January 24, 2003

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

April 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

CV-MMAIT-4-001
JWCI-MC-4-001

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.