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A Prospective, Randomized, Open-Label, Comparative Clinical Trial in Post-Surgical Melanoma Patients With Either DNP-Modified Autologous Tumor Vaccine or Interferon Alpha-2b (NCT00003715)

RATIONALE: Vaccines made from a person's melanoma cells may make the body build an immune response to kill tumor cells. Interferon alfa may interfere with the growth of the cancer cells. PURPOSE: Randomized phase III trial to compare the effectiveness of melanoma vaccine with that of interferon alfa-2b in treating patients who have stage III melanoma that has spread to regional lymph nodes following surgery.
  • Biological: BCG vaccine
    • Biological: autologous tumor cell vaccine
      • Biological: recombinant interferon alfa
        • Drug: chemotherapy
          • Drug: cyclophosphamide
            Ages eligible for Study
            18 Years to 120 Years
            Genders eligible for Study
            All
            Accepts Healthy Volunteers
            No
            OBJECTIVES: I. Compare the relapse-free and overall survival rates in patients with stage III melanoma treated with autologous tumor vaccine versus interferon alfa-2b as postsurgical adjuvant therapy. II. Compare the safety and tolerability of these regimens in this patient population.

            OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to number of metastatic lymph node sites (1 vs more than 1), number of positive lymph nodes in a single site (none vs 1 or more), presence of intransit metastases (yes vs no), and evidence of extranodal extension (yes vs no). Patients are randomized to one of two treatment arms. Arm I: Patients receive autologous tumor cell vaccine intradermally once a week for 7 weeks followed by a booster injection at 6 months. BCG is given concurrently with vaccine as an immune-stimulator for doses 2-8. Patients also receive cyclophosphamide 6 days after the first vaccine injection. Arm II: Patients receive interferon alfa-2b IV for 5 consecutive days a week for 4 weeks followed by maintenance doses given subcutaneously 3 times a week for 48 weeks. Patients are followed monthly for 1 year, every 2 months for 1 year, every 3 months for 1 year, and then every 6 months for 2 years.

            PROJECTED ACCRUAL: A total of 386-425 patients will be accrued for this study.

            17 locations

            United States (17)
            • Cancer and Blood Institute of the Desert
              Rancho Mirage, California, United States, 92270
            • Yale Comprehensive Cancer Center
              New Haven, Connecticut, United States, 06520-8028
            • Columbia - HCA Cancer Research Network
              North Miami Beach, Florida, United States, 33180
            • H. Lee Moffitt Cancer Center and Research Institute
              Tampa, Florida, United States, 33612
            • Georgia Cancer Specialists
              Decatur, Georgia, United States, 30033
            • University of Illinois at Chicago
              Chicago, Illinois, United States, 60612
            • Lutheran General Cancer Care Center
              Park Ridge, Illinois, United States, 60068
            • James Graham Brown Cancer Center
              Louisville, Kentucky, United States, 40202
            • Cancer and Hematology Centers of Western Michigan
              Grand Rapids, Michigan, United States, 49546
            • Hubert H. Humphrey Cancer Center
              Robbinsdale, Minnesota, United States, 55422
            • Midwest Oncology Consortium
              Kansas City, Missouri, United States, 64111
            • Jersey Shore Cancer Center
              Neptune, New Jersey, United States, 07753
            • Cancer Institute of New Jersey
              New Brunswick, New Jersey, United States, 08901
            • Herbert Irving Comprehensive Cancer Center
              New York, New York, United States, 10032
            • University of Pennsylvania Cancer Center
              Philadelphia, Pennsylvania, United States, 19104
            • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
              Philadelphia, Pennsylvania, United States, 19107
            • Palmetto Hematology/Oncology Associates
              Spartanburg, South Carolina, United States, 29303
            Status:
            terminated
            Type:
            Interventional
            Phase:
            Start:
            30 November, 1998
            Updated:
            01 December, 2015
            Participants:
            425
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