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Phase II Study of Allovectin-7 as an Immunotherapeutic Agent in Patients With Stages III and IV Melanoma (NCT00003646)

RATIONALE: Injecting allovectin-7 into a person's melanoma cells may make the body build an immune response that will kill tumor cells. PURPOSE: Phase II trial to study the effectiveness of gene therapy in treating patients who have stage III or stage IV melanoma that has not responded to previous treatment.
  • Drug: allovectin-7
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    OBJECTIVES: I. Demonstrate an objective clinical response (partial or complete) with a median duration of at least 4 months in 15% of patients with stage III or IV melanoma treated with Allovectin-7. Allovectin-7 is a direct gene transfer immunotherapeutic agent.

    II. Determine the benefits, risks, and side effects of Allovectin-7 in this patient population.

    PROTOCOL OUTLINE: This is a multicenter study. Patients receive an intratumoral injection of Allovectin-7 once weekly for 6 weeks. At week 9, a complete disease status assessment is performed. Patients with stable or responding disease may receive additional courses of 6 injections.

    PROJECTED ACCRUAL:

    A total of 70 patients will be accrued for this study.

    3 locations

    United States (3)
    • Mayo Clinic Cancer Center
      Not specified
      Rochester, Minnesota, United States, 55905
    • Roswell Park Cancer Institute
      Not specified
      Buffalo, New York, United States, 14263-0001
    • Physician Reliance Network, Inc.
      Not specified
      Dallas, Texas, United States, 75246
    Status:
    completed
    Type:
    Interventional
    Phase:
    Start:
    31 July, 1998
    Updated:
    04 July, 2011
    Participants:
    78
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