Back to resultsVaccine Therapy for Patients With Stage IV Melanoma
Primary Purpose
Malignant Melanoma
Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
CancerVax vaccine (CANVAXIN)
Sponsored by
About this trial
This is an interventional treatment trial for Malignant Melanoma
Eligibility 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
Sites / Locations
- Arizona Cancer Center
- Central Arkansas Veterans Healthcare System
- University of Arkansas for Medical Sciences
- Kaiser Permanente Medical Group
- Cedars Sinai Comprehensive Cancer Center
- Hoag Memorial Hospital Presbyterian
- Comprehensive Cancer Center at DRMC
- Kaiser Permanente Medical Group
- Kaiser Permanente Medical Group
- Sharp Hospital
- UCSF Cancer Center and Cancer Research Institute
- University of Colorado Cancer Center
- Lakeland Regional Cancer Center
- Mt. Sinai Comprehensive Cancer Center
- University of Miami
- Florida Hospital Cancer Institute
- H. Lee Moffitt Cancer Center and Research Institute
- The Cancer Institute at Good Samaritan Medical Center
- Loyola University Medical Center
- OSF Saint Francis Medica Center
- Wagner and Associates
- James Graham Brown Cancer Center
- St. Agnes Healthcare
- Franklin Square Hospital Center
- Sidney Kimmel Comprehensive Cancer Center
- Boston Medical Center
- Spectrum Health - Butterworth Campus
- Ellis Fischel Cancer Center - Columbia
- St. Louis University Health Sciences Center
- The Cancer Cener at Hackensack University Medical Center
- Medical Center of Princeton
- Millard Fillmore Hospital
- Roswell Park Cancer Institute
- Columbia Presbyterian Medical Center
- Suny Health Science Center at Syracuse
- Lineberger Comprehensive Cancer Center, UNC
- Wake Forest University
- Christ Hospital
- Cleveland Clinic Foundation
- Arthur G. James Cancer Hospital - Ohio State University
- Dayton Clinical Oncology Group
- St. Lukes Hospital Cancer Center
- University of Pennsylvania Cancer Center
- Lankenau Hospital
- Vanderbilt-Ingram Cancer Center
- UT Southwest Medical Center- Dallas
- University of Texas - MD Anderson Cancer Center
- Intermountain Health Care- Mckay-Dee Hospital
- Intermountain Health Care-LDS Hospital
- University of Washington
- Northwest Medical Specialties
- Royal Prince Alfred Hospital, Sydney
- NSW Breast Cancer Institute
- Princess Alexandra Hospital
- Royal Adelaide Hospital
- Peter MacCallum Cancer Center
- The Alfred Hospital
- INCA (National Cancer Institute)
- Hospital Sirio Lebanes
- McGill University
- CHU Pitie-Salpetriere
- Klinikum Augsburg
- Charite- University Medicine
- University of Jena
- University Hospial of Mannheim
- University of Tuebingen
- University of Ulm
- University Hospital Wuerzburg
- Cork University
- Tel-Aviv Medical Center
- Istituto Nazionale Tumori di Milano
- Instituto Eurepeo di Oncologia
- Istituto Nazionale dei Tumori
- University Hospital of Groningen
- North Shore Hospital
- University of Zurich
- Harley Street Clinic
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00052156
Brief Title
Vaccine Therapy for Patients With Stage IV Melanoma
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2005
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
CancerVax Corporation
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Melanoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
670 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
CancerVax vaccine (CANVAXIN)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Central Arkansas Veterans Healthcare System
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Kaiser Permanente Medical Group
City
Anaheim
State/Province
California
Country
United States
Facility Name
Cedars Sinai Comprehensive Cancer Center
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Hoag Memorial Hospital Presbyterian
City
Newport Beach
State/Province
California
ZIP/Postal Code
92658
Country
United States
Facility Name
Comprehensive Cancer Center at DRMC
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Kaiser Permanente Medical Group
City
Riverside
State/Province
California
Country
United States
Facility Name
Kaiser Permanente Medical Group
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Sharp Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
UCSF Cancer Center and Cancer Research Institute
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0128
Country
United States
Facility Name
University of Colorado Cancer Center
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
Lakeland Regional Cancer Center
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Mt. Sinai Comprehensive Cancer Center
City
Miami
State/Province
Florida
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
Country
United States
Facility Name
Florida Hospital Cancer Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9497
Country
United States
Facility Name
The Cancer Institute at Good Samaritan Medical Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
Country
United States
Facility Name
OSF Saint Francis Medica Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Wagner and Associates
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
James Graham Brown Cancer Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
St. Agnes Healthcare
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
Franklin Square Hospital Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center
City
Lutherville
State/Province
Maryland
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118-2393
Country
United States
Facility Name
Spectrum Health - Butterworth Campus
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
Ellis Fischel Cancer Center - Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
St. Louis University Health Sciences Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110-0250
Country
United States
Facility Name
The Cancer Cener at Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Medical Center of Princeton
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Facility Name
Millard Fillmore Hospital
City
Buffalo
State/Province
New York
ZIP/Postal Code
14209
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States
Facility Name
Columbia Presbyterian Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Suny Health Science Center at Syracuse
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center, UNC
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7295
Country
United States
Facility Name
Wake Forest University
City
Winston Salem
State/Province
North Carolina
Country
United States
Facility Name
Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Arthur G. James Cancer Hospital - Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States
Facility Name
Dayton Clinical Oncology Group
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
St. Lukes Hospital Cancer Center
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
University of Pennsylvania Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4283
Country
United States
Facility Name
Lankenau Hospital
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6838
Country
United States
Facility Name
UT Southwest Medical Center- Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235-9154
Country
United States
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Intermountain Health Care- Mckay-Dee Hospital
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Intermountain Health Care-LDS Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Northwest Medical Specialties
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Royal Prince Alfred Hospital, Sydney
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
NSW Breast Cancer Institute
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Peter MacCallum Cancer Center
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia
Facility Name
INCA (National Cancer Institute)
City
Rio de Janeiro
ZIP/Postal Code
20230
Country
Brazil
Facility Name
Hospital Sirio Lebanes
City
Sao Paulo
ZIP/Postal Code
01308-050
Country
Brazil
Facility Name
McGill University
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
CHU Pitie-Salpetriere
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Klinikum Augsburg
City
Augsburg
Country
Germany
Facility Name
Charite- University Medicine
City
Berlin
Country
Germany
Facility Name
University of Jena
City
Jena
ZIP/Postal Code
07740
Country
Germany
Facility Name
University Hospial of Mannheim
City
Mannheim
Country
Germany
Facility Name
University of Tuebingen
City
Tuebingen
Country
Germany
Facility Name
University of Ulm
City
Ulm
Country
Germany
Facility Name
University Hospital Wuerzburg
City
Wuerzburg
Country
Germany
Facility Name
Cork University
City
Cork
Country
Ireland
Facility Name
Tel-Aviv Medical Center
City
Tel Aviv
ZIP/Postal Code
62995
Country
Israel
Facility Name
Istituto Nazionale Tumori di Milano
City
Milan
ZIP/Postal Code
20133
Country
Italy
Facility Name
Instituto Eurepeo di Oncologia
City
Milan
ZIP/Postal Code
20141
Country
Italy
Facility Name
Istituto Nazionale dei Tumori
City
Naples
ZIP/Postal Code
80132
Country
Italy
Facility Name
University Hospital of Groningen
City
Groningen
Country
Netherlands
Facility Name
North Shore Hospital
City
Auckland
ZIP/Postal Code
92024
Country
New Zealand
Facility Name
University of Zurich
City
Zurich
Country
Switzerland
Facility Name
Harley Street Clinic
City
London
State/Province
England
ZIP/Postal Code
SW17 ORE
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
29019177
Citation
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.
Results Reference
derived
PubMed Identifier
22202581
Citation
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.
Results Reference
derived
Links:
URL
http://www.cancervax.com
Description
CancerVax Corporation Website
Learn more about this trial
Vaccine Therapy for Patients With Stage IV Melanoma
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