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Vaccine Therapy for Patients With Stage IV Melanoma

Sponsor
CancerVax Corporation (Industry)
Overall Status
Unknown status
CT.gov ID
NCT00052156
Collaborator
(none)
670
Enrollment
77
Locations
8.7
Patients Per Site

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: CancerVax vaccine (CANVAXIN)
 Phase 3

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
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

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 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

    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 Loyola University Medical Center Maywood Illinois United States
    20 OSF Saint Francis Medica Center Peoria Illinois United States 61637
    21 Wagner and Associates Indianapolis Indiana United States 46256
    22 James Graham Brown Cancer Center Louisville Kentucky United States 40202
    23 St. Agnes Healthcare Baltimore Maryland United States 21229
    24 Franklin Square Hospital Center Baltimore Maryland United States 21237
    25 Sidney Kimmel Comprehensive Cancer Center Lutherville Maryland United States
    26 Boston Medical Center Boston Massachusetts United States 02118-2393
    27 Spectrum Health - Butterworth Campus Grand Rapids Michigan United States 49546
    28 Ellis Fischel Cancer Center - Columbia Columbia Missouri United States 65203
    29 St. Louis University Health Sciences Center Saint Louis Missouri United States 63110-0250
    30 The Cancer Cener at Hackensack University Medical Center Hackensack New Jersey United States 07601
    31 Medical Center of Princeton Princeton New Jersey United States 08540
    32 Millard Fillmore Hospital Buffalo New York United States 14209
    33 Roswell Park Cancer Institute Buffalo New York United States 14263-0001
    34 Columbia Presbyterian Medical Center New York New York United States 10032
    35 Suny Health Science Center at Syracuse Syracuse New York United States 13210
    36 Lineberger Comprehensive Cancer Center, UNC Chapel Hill North Carolina United States 27599-7295
    37 Wake Forest University Winston Salem North Carolina United States
    38 Christ Hospital Cincinnati Ohio United States 45219
    39 Cleveland Clinic Foundation Cleveland Ohio United States
    40 Arthur G. James Cancer Hospital - Ohio State University Columbus Ohio United States 43210-1240
    41 Dayton Clinical Oncology Group Dayton Ohio United States 45409
    42 St. Lukes Hospital Cancer Center Bethlehem Pennsylvania United States 18015
    43 University of Pennsylvania Cancer Center Philadelphia Pennsylvania United States 19104-4283
    44 Lankenau Hospital Wynnewood Pennsylvania United States 19096
    45 Vanderbilt-Ingram Cancer Center Nashville Tennessee United States 37232-6838
    46 UT Southwest Medical Center- Dallas Dallas Texas United States 75235-9154
    47 University of Texas - MD Anderson Cancer Center Houston Texas United States 77030-4009
    48 Intermountain Health Care- Mckay-Dee Hospital Ogden Utah United States 84403
    49 Intermountain Health Care-LDS Hospital Salt Lake City Utah United States 84143
    50 University of Washington Seattle Washington United States 98109
    51 Northwest Medical Specialties Tacoma Washington United States 98405
    52 Royal Prince Alfred Hospital, Sydney Sydney New South Wales Australia 2050
    53 NSW Breast Cancer Institute Westmead New South Wales Australia 2145
    54 Princess Alexandra Hospital Brisbane Queensland Australia 4102
    55 Royal Adelaide Hospital Adelaide South Australia Australia 5000
    56 Peter MacCallum Cancer Center Melbourne Victoria Australia 3002
    57 The Alfred Hospital Melbourne Victoria Australia 3181
    58 INCA (National Cancer Institute) Rio de Janeiro Brazil 20230
    59 Hospital Sirio Lebanes Sao Paulo Brazil 01308-050
    60 McGill University Montreal Quebec Canada
    61 CHU Pitie-Salpetriere Paris France 75651
    62 Klinikum Augsburg Augsburg Germany
    63 Charite- University Medicine Berlin Germany
    64 University of Jena Jena Germany 07740
    65 University Hospial of Mannheim Mannheim Germany
    66 University of Tuebingen Tuebingen Germany
    67 University of Ulm Ulm Germany
    68 University Hospital Wuerzburg Wuerzburg Germany
    69 Cork University Cork Ireland
    70 Tel-Aviv Medical Center Tel Aviv Israel 62995
    71 Istituto Nazionale Tumori di Milano Milan Italy 20133
    72 Instituto Eurepeo di Oncologia Milan Italy 20141
    73 Istituto Nazionale dei Tumori Naples Italy 80132
    74 University Hospital of Groningen Groningen Netherlands
    75 North Shore Hospital Auckland New Zealand 92024
    76 University of Zurich Zurich Switzerland
    77 Harley Street Clinic 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:
    NCT00052156
    Other Study ID Numbers:
    • CV-MMAIT-4-001
    • JWCI-MC-4-001
    • NCT00003722
    First Posted:
    Jan 24, 2003
    Last Update Posted:
    Jun 24, 2005
    Last Verified:
    Apr 1, 2005
    Additional relevant MeSH terms:
    Melanoma

    Study Results

    No Results Posted as of Jun 24, 2005