Vaccine Therapy for Patients With Stage III Melanoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2004 by CancerVax Corporation.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
CancerVax Corporation
ClinicalTrials.gov Identifier:
NCT00052130
First received: January 22, 2003
Last updated: June 23, 2005
Last verified: September 2004
  Purpose

This is a Phase 3 study in patients with melanoma that has spread to the lymph nodes (stage III), 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.


Condition Intervention Phase
Malignant Melanoma
Biological: CancerVax vaccine (CANVAXIN)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Phase III Randomized Double-Blind Pivotal Trial of Immunotherapy With BCG Plus a Polyvalent Melanoma Vaccine, CancerVax™ Vaccine Versus BCG Plus a Placebo as a Post-Surgical Treatment for Stage III Melanoma

Resource links provided by NLM:


Further study details as provided by CancerVax Corporation:

Estimated Enrollment: 1118
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • Must have Stage III 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00052130

  Hide Study Locations
Locations
United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, Arkansas
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, United States, 72205
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Kaiser Permanente Medical Group
Anaheim, California, United States
Cedars Sinai Comprehensive Cancer Center
Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92658
Comprehensive Cancer Center at DRMC
Palm Springs, California, United States, 92262
Kaiser Permanente Medical Group
Riverside, California, United States
Kaiser Permanente Medical Group
San Diego, California, United States, 92120
Sharp Hospital
San Diego, California, United States, 92123
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States, 94143-0128
United States, Colorado
University of Colorado Cancer Center
Aurora, Colorado, United States
United States, Florida
Lakeland Regional Cancer Center
Lakeland, Florida, United States, 33805
University of Miami
Miami, Florida, United States
Mt. Sinai Comprehensive Cancer Center
Miami, Florida, United States
Florida Hospital Cancer Institute
Orlando, Florida, United States, 32804
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497
The Cancer Institute at Good Samaritan Medical Center
West Palm Beach, Florida, United States, 33401
United States, Georgia
Winship Cancer Institute at Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States
OSF Saint Francis Medica Center
Peoria, Illinois, United States, 61637
United States, Indiana
Cancer Care of Southern Indiana
Bloomington, Indiana, United States, 47402
Wagner and Associates
Indianapolis, Indiana, United States, 46256
United States, Kentucky
James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202
United States, Maryland
Franklin Square Hospital Center
Baltimore, Maryland, United States, 21237
St. Agnes Healthcare
Baltimore, Maryland, United States, 21229
Sidney Kimmel Comprehensive Cancer Center
Lutherville, Maryland, United States
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118-2393
United States, Michigan
University of Michigan Medical Center
Ann Arbor, Michigan, United States
Spectrum Health - Butterworth Campus
Grand Rapids, Michigan, United States, 49546
United States, Missouri
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States, 65203
St. Louis University Health Sciences Center
Saint Louis, Missouri, United States, 63110-0250
United States, New Jersey
The Cancer Cener at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Medical Center of Princeton
Princeton, New Jersey, United States, 08540
United States, New York
Millard Fillmore Hospital
Buffalo, New York, United States, 14209
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Columbia Presbyterian Medical Center
New York, New York, United States, 10032
Suny Health Science Center at Syracuse
Syracuse, New York, United States, 13210
United States, North Carolina
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States, 27599-7295
United States, Ohio
Christ Hospital
Cincinnati, Ohio, United States, 45219
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210-1240
Dayton Clinical Oncology Group
Dayton, Ohio, United States, 45409
United States, Pennsylvania
St. Lukes Hospital Cancer Center
Bethlehem, Pennsylvania, United States, 18015
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States, 19104-4283
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
United States, Texas
UT Southwest Medical Center- Dallas
Dallas, Texas, United States, 75235-9154
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
United States, Utah
Intermountain Health Care- Mckay-Dee Hospital
Ogden, Utah, United States, 84403
Intermountain Health Care-LDS Hospital
Salt Lake City, Utah, United States, 84143
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Northwest Medical Specialties
Tacoma, Washington, United States, 98405
Australia, New South Wales
Royal Prince Alfred Hospital, Sydney
Sydney, New South Wales, Australia, 2050
NSW Breast Cancer Institute
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Princess Alexandra Hospital
Brisbane, Queensland, Australia, 4102
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
The Alfred Hospital
Melbourne, Victoria, Australia, 3181
Peter MacCallum Cancer Center
Melbourne, Victoria, Australia, 3002
Brazil
INCA (National Cancer Institute)
Rio de Janeiro, Brazil, 20230
Hospital Sirio Lebanes
Sao Paulo, Brazil, 01308-050
Canada, Quebec
McGill University
Montreal, Quebec, Canada
France
CHU Pitie-Salpetriere
Paris, France, 75651
Germany
Klinikum Augsburg
Augsburg, Germany
Charite- University Medicine
Berlin, Germany
University of Jena
Jena, Germany
University Hospial of Mannheim
Mannheim, Germany
University of Tuebingen
Tuebingen, Germany
University of Ulm
Ulm, Germany
University Hospital Wuerzburg
Wuerzburg, Germany
Ireland
Cork University
Cork, Ireland
Israel
Tel-Aviv Medical Center
Tel Aviv, Israel, 62995
Italy
Instituto Eurepeo di Oncologia
Milan, Italy, 20141
Istituto Nazionale Tumori di Milano
Milan, Italy, 20133
Istituto Nazionale dei Tumori
Naples, Italy, 80132
Netherlands
University Hospital of Groningen
Groningen, Netherlands
New Zealand
North Shore Hospital
Auckland, New Zealand, 92024
Switzerland
University of Zurich
Zurich, Switzerland
United Kingdom
St. Georges Hospital Medical School
London, England, United Kingdom, SW17 ORE
Sponsors and Collaborators
CancerVax Corporation
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00052130     History of Changes
Obsolete Identifiers: NCT00004130
Other Study ID Numbers: CV-MMAIT-3-001, JWCI-MC-3-001A
Study First Received: January 22, 2003
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on September 16, 2014