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
Recruitment status was Active, not recruiting
Sponsor:
CancerVax Corporation
Information provided by:
CancerVax Corporation
ClinicalTrials.gov Identifier:
NCT00052130
First received: January 22, 2003
Last updated: June 23, 2005
Last verified: September 2004
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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:
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00052130
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Hide Study LocationsLocations
| 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 June 18, 2013