Clinical trial NCT00052156: Vaccine Therapy for Patients With Stage IV Melanoma
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Malignant Melanoma
Lead sponsor: CancerVax Corporation
Sponsor class: INDUSTRY
First posted: 2003-01-24
Enrollment: 670
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Cancer Center
state: Arizona
city: Little Rock
country: United States
facility: Central Arkansas Veterans Healthcare System
state: Arkansas
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Anaheim
country: United States
facility: Kaiser Permanente Medical Group
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Comprehensive Cancer Center
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
city: Palm Springs
country: United States
facility: Comprehensive Cancer Center at DRMC
state: California
city: Riverside
country: United States
facility: Kaiser Permanente Medical Group
state: California
city: San Diego
country: United States
facility: Kaiser Permanente Medical Group
state: California
city: San Diego
country: United States
facility: Sharp Hospital
state: California
city: San Francisco
country: United States
facility: UCSF Cancer Center and Cancer Research Institute
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Lakeland
country: United States
facility: Lakeland Regional Cancer Center
state: Florida
city: Miami
country: United States
facility: Mt. Sinai Comprehensive Cancer Center
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Orlando
country: United States
facility: Florida Hospital Cancer Institute
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
city: West Palm Beach
country: United States
facility: The Cancer Institute at Good Samaritan Medical Center
state: Florida
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Peoria
country: United States
facility: OSF Saint Francis Medica Center
state: Illinois
city: Indianapolis
country: United States
facility: Wagner and Associates
state: Indiana
city: Louisville
country: United States
facility: James Graham Brown Cancer Center
state: Kentucky
city: Baltimore
country: United States
facility: St. Agnes Healthcare
state: Maryland
city: Baltimore
country: United States
facility: Franklin Square Hospital Center
state: Maryland
city: Lutherville
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Grand Rapids
country: United States
facility: Spectrum Health - Butterworth Campus
state: Michigan
city: Columbia
country: United States
facility: Ellis Fischel Cancer Center - Columbia
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis University Health Sciences Center
state: Missouri
city: Hackensack
country: United States
facility: The Cancer Cener at Hackensack University Medical Center
state: New Jersey
city: Princeton
country: United States
facility: Medical Center of Princeton
state: New Jersey
city: Buffalo
country: United States
facility: Millard Fillmore Hospital
state: New York
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: New York
country: United States
facility: Columbia Presbyterian Medical Center
state: New York
city: Syracuse
country: United States
facility: Suny Health Science Center at Syracuse
state: New York
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center, UNC
state: North Carolina
city: Winston Salem
country: United States
facility: Wake Forest University
state: North Carolina
city: Cincinnati
country: United States
facility: Christ Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Arthur G. James Cancer Hospital - Ohio State University
state: Ohio
city: Dayton
country: United States
facility: Dayton Clinical Oncology Group
state: Ohio
city: Bethlehem
country: United States
facility: St. Lukes Hospital Cancer Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Cancer Center
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Hospital
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
city: Dallas
country: United States
facility: UT Southwest Medical Center- Dallas
state: Texas
city: Houston
country: United States
facility: University of Texas - MD Anderson Cancer Center
state: Texas
city: Ogden
country: United States
facility: Intermountain Health Care- Mckay-Dee Hospital
state: Utah
city: Salt Lake City
country: United States
facility: Intermountain Health Care-LDS Hospital
state: Utah
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Tacoma
country: United States
facility: Northwest Medical Specialties
state: Washington
city: Sydney
country: Australia
facility: Royal Prince Alfred Hospital, Sydney
state: New South Wales
city: Westmead
country: Australia
facility: NSW Breast Cancer Institute
state: New South Wales
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Center
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Rio de Janeiro
country: Brazil
facility: INCA (National Cancer Institute)
city: Sao Paulo
country: Brazil
facility: Hospital Sirio Lebanes
city: Montreal
country: Canada
facility: McGill University
state: Quebec
city: Paris
country: France
facility: CHU Pitie-Salpetriere
city: Augsburg
country: Germany
facility: Klinikum Augsburg
city: Berlin
country: Germany
facility: Charite- University Medicine
city: Jena
country: Germany
facility: University of Jena
city: Mannheim
country: Germany
facility: University Hospial of Mannheim
city: Tuebingen
country: Germany
facility: University of Tuebingen
city: Ulm
country: Germany
facility: University of Ulm
city: Wuerzburg
country: Germany
facility: University Hospital Wuerzburg
city: Cork
country: Ireland
facility: Cork University
city: Tel Aviv
country: Israel
facility: Tel-Aviv Medical Center
city: Milan
country: Italy
facility: Istituto Nazionale Tumori di Milano
city: Milan
country: Italy
facility: Instituto Eurepeo di Oncologia
city: Naples
country: Italy
facility: Istituto Nazionale dei Tumori
city: Groningen
country: Netherlands
facility: University Hospital of Groningen
city: Auckland
country: New Zealand
facility: North Shore Hospital
city: Zurich
country: Switzerland
facility: University of Zurich
city: London
country: United Kingdom
facility: Harley Street Clinic
state: England
Study officials:
References:
citation: Faries MB, Mozzillo N, Kashani-Sabet M, Thompson JF, Kelley MC, DeConti RC, Lee JE, Huth JF, Wagner J, Dalgleish A, Pertschuk D, Nardo C, Stern S, Elashoff R, Gammon G, Morton DL; MMAIT-IV Clinical Trial Group. Long-Term Survival after Complete Surgical Resection and Adjuvant Immunotherapy for Distant Melanoma Metastases. Ann Surg Oncol. 2017 Dec;24(13):3991-4000. doi: 10.1245/s10434-017-6072-3. Epub 2017 Oct 10.
citation: Hoshimoto S, Faries MB, Morton DL, Shingai T, Kuo C, Wang HJ, Elashoff R, Mozzillo N, Kelley MC, Thompson JF, Lee JE, Hoon DS. Assessment of prognostic circulating tumor cells in a phase III trial of adjuvant immunotherapy after complete resection of stage IV melanoma. Ann Surg. 2012 Feb;255(2):357-62. doi: 10.1097/SLA.0b013e3182380f56.