Malignant Melanoma Clinical Trial
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
| Verified date | September 2004 |
| Source | CancerVax Corporation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 1118 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
- 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Australia | Royal Adelaide Hospital | Adelaide | South Australia |
| Australia | Princess Alexandra Hospital | Brisbane | Queensland |
| Australia | Peter MacCallum Cancer Center | Melbourne | Victoria |
| Australia | The Alfred Hospital | Melbourne | Victoria |
| Australia | Royal Prince Alfred Hospital, Sydney | Sydney | New South Wales |
| Australia | NSW Breast Cancer Institute | Westmead | New South Wales |
| Brazil | INCA (National Cancer Institute) | Rio de Janeiro | |
| Brazil | Hospital Sirio Lebanes | Sao Paulo | |
| Canada | McGill University | Montreal | Quebec |
| France | CHU Pitie-Salpetriere | Paris | |
| 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 | |
| Ireland | Cork University | Cork | |
| Israel | Tel-Aviv Medical Center | Tel Aviv | |
| Italy | Instituto Eurepeo di Oncologia | Milan | |
| Italy | Istituto Nazionale Tumori di Milano | Milan | |
| Italy | Istituto Nazionale dei Tumori | Naples | |
| Netherlands | University Hospital of Groningen | Groningen | |
| New Zealand | North Shore Hospital | Auckland | |
| Switzerland | University of Zurich | Zurich | |
| United Kingdom | St. Georges Hospital Medical School | London | England |
| United States | Kaiser Permanente Medical Group | Anaheim | California |
| United States | University of Michigan Medical Center | Ann Arbor | Michigan |
| United States | Winship Cancer Institute at Emory University | Atlanta | Georgia |
| United States | University of Colorado Cancer Center | Aurora | Colorado |
| United States | Franklin Square Hospital Center | Baltimore | Maryland |
| United States | St. Agnes Healthcare | Baltimore | Maryland |
| United States | St. Lukes Hospital Cancer Center | Bethlehem | Pennsylvania |
| United States | Cancer Care of Southern Indiana | Bloomington | Indiana |
| United States | Boston Medical Center | Boston | Massachusetts |
| United States | Millard Fillmore Hospital | Buffalo | New York |
| United States | Roswell Park Cancer Institute | Buffalo | New York |
| United States | Lineberger Comprehensive Cancer Center, UNC | Chapel Hill | North Carolina |
| United States | Christ Hospital | Cincinnati | Ohio |
| United States | Cleveland Clinic Foundation | Cleveland | Ohio |
| United States | Ellis Fischel Cancer Center - Columbia | Columbia | Missouri |
| United States | Arthur G. James Cancer Hospital - Ohio State University | Columbus | Ohio |
| United States | UT Southwest Medical Center- Dallas | Dallas | Texas |
| United States | Dayton Clinical Oncology Group | Dayton | Ohio |
| United States | Spectrum Health - Butterworth Campus | Grand Rapids | Michigan |
| United States | The Cancer Cener at Hackensack University Medical Center | Hackensack | New Jersey |
| United States | University of Texas - MD Anderson Cancer Center | Houston | Texas |
| United States | Wagner and Associates | Indianapolis | Indiana |
| United States | Lakeland Regional Cancer Center | Lakeland | Florida |
| United States | Central Arkansas Veterans Healthcare System | Little Rock | Arkansas |
| United States | University of Arkansas for Medical Sciences | Little Rock | Arkansas |
| United States | Cedars Sinai Comprehensive Cancer Center | Los Angeles | California |
| United States | James Graham Brown Cancer Center | Louisville | Kentucky |
| United States | Sidney Kimmel Comprehensive Cancer Center | Lutherville | Maryland |
| United States | Loyola University Medical Center | Maywood | Illinois |
| United States | Mt. Sinai Comprehensive Cancer Center | Miami | Florida |
| United States | University of Miami | Miami | Florida |
| United States | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee |
| United States | Columbia Presbyterian Medical Center | New York | New York |
| United States | Hoag Memorial Hospital Presbyterian | Newport Beach | California |
| United States | Intermountain Health Care- Mckay-Dee Hospital | Ogden | Utah |
| United States | Florida Hospital Cancer Institute | Orlando | Florida |
| United States | Comprehensive Cancer Center at DRMC | Palm Springs | California |
| United States | OSF Saint Francis Medica Center | Peoria | Illinois |
| United States | Fox Chase Cancer Center | Philadelphia | Pennsylvania |
| United States | University of Pennsylvania Cancer Center | Philadelphia | Pennsylvania |
| United States | Medical Center of Princeton | Princeton | New Jersey |
| United States | Kaiser Permanente Medical Group | Riverside | California |
| United States | St. Louis University Health Sciences Center | Saint Louis | Missouri |
| United States | Intermountain Health Care-LDS Hospital | Salt Lake City | Utah |
| United States | Kaiser Permanente Medical Group | San Diego | California |
| United States | Sharp Hospital | San Diego | California |
| United States | UCSF Cancer Center and Cancer Research Institute | San Francisco | California |
| United States | University of Washington | Seattle | Washington |
| United States | Suny Health Science Center at Syracuse | Syracuse | New York |
| United States | Northwest Medical Specialties | Tacoma | Washington |
| United States | H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida |
| United States | Arizona Cancer Center | Tucson | Arizona |
| United States | The Cancer Institute at Good Samaritan Medical Center | West Palm Beach | Florida |
| United States | Lankenau Hospital | Wynnewood | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| CancerVax Corporation |
United States, Australia, Brazil, Canada, France, Germany, Ireland, Israel, Italy, Netherlands, New Zealand, Switzerland, United Kingdom,
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