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Phase III Randomized Study of Dacarbazine With or Without Allovectin-7 in Patients With Metastatic Melanoma (NCT00003647)

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Injecting allovectin-7 into a person's melanoma cells may make the body build an immune response that will kill tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of dacarbazine with or without immunotherapy in treating patients who have stage III or stage IV melanoma.
  • Drug: allovectin-7
    • Drug: allovectin-7/dacarbazine
      • Drug: dacarbazine
        Ages eligible for Study
        18 Years and older
        Genders eligible for Study
        All
        Accepts Healthy Volunteers
        OBJECTIVES: I. Demonstrate either an improvement in the median time to disease progression by at least 2 months with no decrease in the rate of objective clinical response OR an improvement by at least 15% in the rate of objective clinical response with no decrease in the median time to disease progression in patients with stage III or IV melanoma receiving dacarbazine with Allovectin-7 when compared with patients receiving dacarbazine alone.

        II. Determine the benefits, risks, and side effects of these regimens in this patient population.

        PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified according to sex, age, and spread of disease (cutaneous or nodal vs visceral disease). Patients are randomized to one of two treatment arms.

        Arm I: Patients receive dacarbazine IV over 1 hour on day 0. Arm II: Patients receive treatment as in arm I. Patients also receive Allovectin-7 intratumorally on days 3 and 10.

        Patients with stable or responding disease may receive additional courses every 28 days.

        Patients are followed every 4 months.

        PROJECTED ACCRUAL:

        A total of 280 patients (140 in each arm) will be accrued for this study.

        44 locations

        United States (44)
        • University of Arkansas for Medical Sciences
          Not specified
          Little Rock, Arkansas, United States, 72205
        • Comprehensive Blood and Cancer Center
          Not specified
          Bakersfield, California, United States, 93309
        • Scripps Memorial Hospitals-Stevens Cancer Center - Encinitas
          Not specified
          Encinitas, California, United States, 92023
        • Kaiser Permanente-Southern California Permanente Medical Group
          Not specified
          San Diego, California, United States, 92120
        • Yale Comprehensive Cancer Center
          Not specified
          New Haven, Connecticut, United States, 06520-8028
        • Washington Cancer Institute
          Not specified
          Washington, District of Columbia, United States, 20010
        • Mount Sinai Comprehensive Cancer Center
          Not specified
          Miami Beach, Florida, United States, 33140
        • H. Lee Moffitt Cancer Center and Research Institute
          Not specified
          Tampa, Florida, United States, 33612-9497
        • Georgia Cancer Specialists
          Not specified
          Decatur, Georgia, United States, 30033
        • Georgia Cancer Specialists, P.C.
          Not specified
          East Point, Georgia, United States, 30344
        • St. Francis Medical Center
          Not specified
          Honolulu, Hawaii, United States, 96817
        • Robert H. Lurie Comprehensive Cancer Center, Northwestern University
          Not specified
          Chicago, Illinois, United States, 60611-3013
        • Lutheran General Hospital
          Not specified
          Park Ridge, Illinois, United States, 60068
        • Cancer Care Center for Southern Indiana
          Not specified
          Bloomington, Indiana, United States, 47403
        • Cancer Care Center
          Not specified
          New Albany, Indiana, United States, 47150
        • Oncology and Hematology Associates
          Not specified
          Westwood, Kansas, United States, 66205
        • Lucille Parker Markey Cancer Center, University of Kentucky
          Not specified
          Lexington, Kentucky, United States, 40536-0093
        • Louisiana State University School of Medicine
          Not specified
          New Orleans, Louisiana, United States, 70112-2822
        • Franklin Square Hospital Center
          Not specified
          Baltimore, Maryland, United States, 21237
        • Providence Hospital Cancer Center
          Not specified
          Southfield, Michigan, United States, 48075
        • Virginia Piper Cancer Institute
          Not specified
          Minneapolis, Minnesota, United States, 55407
        • North Memorial Health Care
          Not specified
          Robbinsdale, Minnesota, United States, 55422
        • Mayo Clinic Cancer Center
          Not specified
          Rochester, Minnesota, United States, 55905
        • Park Nicollet Clinic
          Not specified
          St. Louis Park, Minnesota, United States, 55416
        • St. Louis University Health Sciences Center
          Not specified
          Saint Louis, Missouri, United States, 63110-0250
        • Missouri Baptist Cancer Center
          Not specified
          Saint Louis, Missouri, United States, 63131
        • Billings Interhospital Oncology Project
          Not specified
          Billings, Montana, United States, 59101
        • Bergan Mercy Medical Center
          Not specified
          Omaha, Nebraska, United States, 68124
        • Norris Cotton Cancer Center
          Not specified
          Lebanon, New Hampshire, United States, 03756-0002
        • HemOnCare, P.C.
          Not specified
          Brooklyn, New York, United States, 11235
        • Arena Oncology Associates
          Not specified
          Great Neck, New York, United States, 11021
        • Beth Israel Medical Center
          Not specified
          New York, New York, United States, 10003
        • Mount Sinai School of Medicine
          Not specified
          New York, New York, United States, 10029
        • Comprehensive Cancer Center at Wake Forest University
          Not specified
          Winston-Salem, North Carolina, United States, 27157-1082
        • Mid Dakota Clinic, P.C.
          Not specified
          Bismarck, North Dakota, United States, 58501
        • Mid-Ohio Oncology/Hematology, Inc.
          Not specified
          Columbus, Ohio, United States, 43222
        • Toledo Clinic, Inc.
          Not specified
          Toledo, Ohio, United States, 43623
        • University of Pennsylvania Cancer Center
          Not specified
          Philadelphia, Pennsylvania, United States, 19104-4283
        • Cancer Centers of the Carolinas
          Not specified
          Greenville, South Carolina, United States, 29605
        • Huntsman Cancer Institute
          Not specified
          Salt Lake City, Utah, United States, 84112
        • Danville Hematology and Oncology, Inc.
          Not specified
          Danville, Virginia, United States, 24541
        • Cancer Treatment Centers of America in Hampton Roads
          Not specified
          Portsmouth, Virginia, United States, 23704
        • Seattle Cancer Care Alliance
          Not specified
          Seattle, Washington, United States, 98109
        • Medical College of Wisconsin
          Not specified
          Milwaukee, Wisconsin, United States, 53226
        Status:
        completed
        Type:
        Interventional
        Phase:
        Start:
        30 June, 1998
        Updated:
        22 July, 2008
        Participants:
        0
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