Vaccine Therapy for Patients With Stage III Melanoma
Sponsor
CancerVax Corporation (Industry)
Overall Status
Unknown status
CT.gov ID
NCT00052130
Collaborator
(none)
1,118
80
14
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
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
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
-
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Arizona Cancer Center | Tucson | Arizona | United States | 85724 |
| 2 | Central Arkansas Veterans Healthcare System | Little Rock | Arkansas | United States | 72205 |
| 3 | University of Arkansas for Medical Sciences | Little Rock | Arkansas | United States | 72205 |
| 4 | Kaiser Permanente Medical Group | Anaheim | California | United States | |
| 5 | Cedars Sinai Comprehensive Cancer Center | Los Angeles | California | United States | |
| 6 | Hoag Memorial Hospital Presbyterian | Newport Beach | California | United States | 92658 |
| 7 | Comprehensive Cancer Center at DRMC | Palm Springs | California | United States | 92262 |
| 8 | Kaiser Permanente Medical Group | Riverside | California | United States | |
| 9 | Kaiser Permanente Medical Group | San Diego | California | United States | 92120 |
| 10 | Sharp Hospital | San Diego | California | United States | 92123 |
| 11 | UCSF Cancer Center and Cancer Research Institute | San Francisco | California | United States | 94143-0128 |
| 12 | University of Colorado Cancer Center | Aurora | Colorado | United States | |
| 13 | Lakeland Regional Cancer Center | Lakeland | Florida | United States | 33805 |
| 14 | Mt. Sinai Comprehensive Cancer Center | Miami | Florida | United States | |
| 15 | University of Miami | Miami | Florida | United States | |
| 16 | Florida Hospital Cancer Institute | Orlando | Florida | United States | 32804 |
| 17 | H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | United States | 33612-9497 |
| 18 | The Cancer Institute at Good Samaritan Medical Center | West Palm Beach | Florida | United States | 33401 |
| 19 | Winship Cancer Institute at Emory University | Atlanta | Georgia | United States | 30322 |
| 20 | Loyola University Medical Center | Maywood | Illinois | United States | |
| 21 | OSF Saint Francis Medica Center | Peoria | Illinois | United States | 61637 |
| 22 | Cancer Care of Southern Indiana | Bloomington | Indiana | United States | 47402 |
| 23 | Wagner and Associates | Indianapolis | Indiana | United States | 46256 |
| 24 | James Graham Brown Cancer Center | Louisville | Kentucky | United States | 40202 |
| 25 | St. Agnes Healthcare | Baltimore | Maryland | United States | 21229 |
| 26 | Franklin Square Hospital Center | Baltimore | Maryland | United States | 21237 |
| 27 | Sidney Kimmel Comprehensive Cancer Center | Lutherville | Maryland | United States | |
| 28 | Boston Medical Center | Boston | Massachusetts | United States | 02118-2393 |
| 29 | University of Michigan Medical Center | Ann Arbor | Michigan | United States | |
| 30 | Spectrum Health - Butterworth Campus | Grand Rapids | Michigan | United States | 49546 |
| 31 | Ellis Fischel Cancer Center - Columbia | Columbia | Missouri | United States | 65203 |
| 32 | St. Louis University Health Sciences Center | Saint Louis | Missouri | United States | 63110-0250 |
| 33 | The Cancer Cener at Hackensack University Medical Center | Hackensack | New Jersey | United States | 07601 |
| 34 | Medical Center of Princeton | Princeton | New Jersey | United States | 08540 |
| 35 | Millard Fillmore Hospital | Buffalo | New York | United States | 14209 |
| 36 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263-0001 |
| 37 | Columbia Presbyterian Medical Center | New York | New York | United States | 10032 |
| 38 | Suny Health Science Center at Syracuse | Syracuse | New York | United States | 13210 |
| 39 | Lineberger Comprehensive Cancer Center, UNC | Chapel Hill | North Carolina | United States | 27599-7295 |
| 40 | Christ Hospital | Cincinnati | Ohio | United States | 45219 |
| 41 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | |
| 42 | Arthur G. James Cancer Hospital - Ohio State University | Columbus | Ohio | United States | 43210-1240 |
| 43 | Dayton Clinical Oncology Group | Dayton | Ohio | United States | 45409 |
| 44 | St. Lukes Hospital Cancer Center | Bethlehem | Pennsylvania | United States | 18015 |
| 45 | University of Pennsylvania Cancer Center | Philadelphia | Pennsylvania | United States | 19104-4283 |
| 46 | Fox Chase Cancer Center | Philadelphia | Pennsylvania | United States | 19111 |
| 47 | Lankenau Hospital | Wynnewood | Pennsylvania | United States | 19096 |
| 48 | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | United States | 37232-6838 |
| 49 | UT Southwest Medical Center- Dallas | Dallas | Texas | United States | 75235-9154 |
| 50 | University of Texas - MD Anderson Cancer Center | Houston | Texas | United States | 77030-4009 |
| 51 | Intermountain Health Care- Mckay-Dee Hospital | Ogden | Utah | United States | 84403 |
| 52 | Intermountain Health Care-LDS Hospital | Salt Lake City | Utah | United States | 84143 |
| 53 | University of Washington | Seattle | Washington | United States | 98195 |
| 54 | Northwest Medical Specialties | Tacoma | Washington | United States | 98405 |
| 55 | Royal Prince Alfred Hospital, Sydney | Sydney | New South Wales | Australia | 2050 |
| 56 | NSW Breast Cancer Institute | Westmead | New South Wales | Australia | 2145 |
| 57 | Princess Alexandra Hospital | Brisbane | Queensland | Australia | 4102 |
| 58 | Royal Adelaide Hospital | Adelaide | South Australia | Australia | 5000 |
| 59 | Peter MacCallum Cancer Center | Melbourne | Victoria | Australia | 3002 |
| 60 | The Alfred Hospital | Melbourne | Victoria | Australia | 3181 |
| 61 | INCA (National Cancer Institute) | Rio de Janeiro | Brazil | 20230 | |
| 62 | Hospital Sirio Lebanes | Sao Paulo | Brazil | 01308-050 | |
| 63 | McGill University | Montreal | Quebec | Canada | |
| 64 | CHU Pitie-Salpetriere | Paris | France | 75651 | |
| 65 | Klinikum Augsburg | Augsburg | Germany | ||
| 66 | Charite- University Medicine | Berlin | Germany | ||
| 67 | University of Jena | Jena | Germany | ||
| 68 | University Hospial of Mannheim | Mannheim | Germany | ||
| 69 | University of Tuebingen | Tuebingen | Germany | ||
| 70 | University of Ulm | Ulm | Germany | ||
| 71 | University Hospital Wuerzburg | Wuerzburg | Germany | ||
| 72 | Cork University | Cork | Ireland | ||
| 73 | Tel-Aviv Medical Center | Tel Aviv | Israel | 62995 | |
| 74 | Istituto Nazionale Tumori di Milano | Milan | Italy | 20133 | |
| 75 | Instituto Eurepeo di Oncologia | Milan | Italy | 20141 | |
| 76 | Istituto Nazionale dei Tumori | Naples | Italy | 80132 | |
| 77 | University Hospital of Groningen | Groningen | Netherlands | ||
| 78 | North Shore Hospital | Auckland | New Zealand | 92024 | |
| 79 | University of Zurich | Zurich | Switzerland | ||
| 80 | St. Georges Hospital Medical School | London | England | United Kingdom | SW17 ORE |
Sponsors and Collaborators
- CancerVax Corporation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00052130
Other Study ID Numbers:
- CV-MMAIT-3-001
- JWCI-MC-3-001A
- NCT00004130
First Posted:
Jan 24, 2003
Last Update Posted:
Jun 24, 2005
Last Verified:
Sep 1, 2004
Additional relevant MeSH terms: