Malignant Melanoma Clinical Trial
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
| Verified date | April 2005 |
| 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 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.
| Status | Active, not recruiting |
| Enrollment | 670 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
- 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 |
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 | Harley Street Clinic | London | England |
| United States | Kaiser Permanente Medical Group | Anaheim | California |
| 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 | 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 | 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 | Wake Forest University | Winston Salem | North Carolina |
| 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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