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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
670

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

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

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 23, 2003

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2003

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 24, 2003

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2005

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2005

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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