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
Phase 3
18 Years
80 Years
18 Years
80 Years
Open (Enrolling)
Both
Malignant Melanoma
Both
Malignant Melanoma
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Authority:
United States: Food and Drug Administration
Study ID:
CV-MMAIT-4-001
NCT ID:
NCT00052156
Start Date:
Completion Date:
Related Keywords:
- Malignant Melanoma
- Melanoma
Name | Location |
|---|---|
| Wake Forest University | Winston-Salem, North Carolina 27103 |
| Arizona Cancer Center | Tucson, Arizona 85724 |
| Cleveland Clinic Foundation | Cleveland, Ohio 44195 |
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
| University of Colorado Cancer Center | Denver, Colorado 80262 |
| H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
| Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina 27599-7295 |
| Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
| University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
| UCSF Cancer Center and Cancer Research Institute | San Francisco, California 94115-0128 |
| Ellis Fischel Cancer Center - Columbia | Columbia, Missouri 65203 |
| Hoag Memorial Hospital Presbyterian | Newport Beach, California 92658 |
| Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
| Loyola University Medical Center | Maywood, Illinois 60153 |
| James Graham Brown Cancer Center | Louisville, Kentucky 40202 |
| St. Louis University Health Sciences Center | Saint Louis, Missouri 63110-0250 |
| Christ Hospital | Cincinnati, Ohio 45219 |
| University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
| Boston Medical Center | Boston, Massachusetts 02118 |
| Franklin Square Hospital Center | Baltimore, Maryland 21237 |
| Florida Hospital Cancer Institute | Orlando, Florida 32804 |
| Medical Center of Princeton | Princeton, New Jersey 08540 |
| Kaiser Permanente Medical Group | Los Angeles, California 90027 |
| Spectrum Health - Butterworth Campus | Grand Rapids, Michigan 49546 |
| University of Washington | Seattle, Washington 98195 |
| St. Agnes Healthcare | Baltimore, Maryland 21229 |
| Millard Fillmore Hospital | Buffalo, New York 14209 |
| Lakeland Regional Cancer Center | Lakeland, Florida 33805 |
| Columbia Presbyterian Medical Center | New York, New York 10032 |
| University of Miami | Miami, Florida 33136 |
| Central Arkansas Veterans Healthcare System | Little Rock, Arkansas 72205 |
| Cedars Sinai Comprehensive Cancer Center | Los Angeles, California |
| Comprehensive Cancer Center at DRMC | Palm Springs, California 92262 |
| Sharp Hospital | San Diego, California 92123 |
| Mt. Sinai Comprehensive Cancer Center | Miami, Florida |
| The Cancer Institute at Good Samaritan Medical Center | West Palm Beach, Florida 33401 |
| OSF Saint Francis Medica Center | Peoria, Illinois 61637 |
| Wagner and Associates | Indianapolis, Indiana 46256 |
| Sidney Kimmel Comprehensive Cancer Center | Lutherville, Maryland |
| The Cancer Cener at Hackensack University Medical Center | Hackensack, New Jersey 07601 |
| Suny Health Science Center at Syracuse | Syracuse, New York 13210 |
| Dayton Clinical Oncology Group | Dayton, Ohio 45409 |
| St. Lukes Hospital Cancer Center | Bethlehem, Pennsylvania 18015 |
| Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
| UT Southwest Medical Center- Dallas | Dallas, Texas 75235-9154 |
| Intermountain Health Care- Mckay-Dee Hospital | Ogden, Utah 84403 |
| Intermountain Health Care-LDS Hospital | Salt Lake City, Utah 84143 |
| Northwest Medical Specialties | Tacoma, Washington 98405 |
