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Phase I Trial of a Dendritic Cell Vaccine for Melanoma (NCT00003665)

Randomized phase I trial to study the effectiveness of vaccine therapy in treating patients who have stage IV melanoma. Vaccines may make the body build an immune response to kill tumor cells.
  • Biological: dendritic cell-MART-1 peptide vaccine
    • Biological: gp100 antigen
      • Biological: therapeutic tumor infiltrating lymphocytes
        • Biological: tyrosinase peptide
          Ages eligible for Study
          18 Years and older
          Genders eligible for Study
          All
          Accepts Healthy Volunteers
          No
          OBJECTIVES:

          I. Determine the dose-limiting toxicities, maximum tolerated dose, recommended phase II dose, and rate of sensitization of T cells at each dose level in patients with melanoma receiving dendritic cell vaccine.

          II. Determine the overall (complete and partial) response rate, duration of response, and optimal route of administration in this patient population.

          OUTLINE: This is a dose escalation study. Patients are randomized to one of three treatment arms.

          All patients undergo leukopheresis to obtain lymphocyte and myeloid origin mononuclear cell fractions for preparation of dendritic cell (DC) vaccine. In each arm, cohorts of up to 5 patients receive escalating doses of vaccine. The maximum tolerated dose (MTD) is defined as the dose preceding that at which 2 or more of 5 patients experience dose-limiting toxicity. Randomization ceases if the MTD has been reached in 2 arms, although accrual may continue. Treatment repeats every 2 weeks for a total of 4 doses.

          Arm I: Patients receive 3 different doses of peptide pulsed DC vaccine IV, each divided into 3 different peptide pulsed pools administered over 30 minutes.

          Arm II: Patients receive 3 different doses of peptide pulsed DC vaccine subcutaneously/intradermally to sites with no evidence of disease. At the lowest dose, patients receive 3 different peptide pulsed pools, each administered at a separate site. At the higher doses, patients receive 3 injections further subdivided into 6 and administered at 6 distinct sites.

          Arm III: Patients receive peptide pulsed DC vaccine intranodally in groin or ancillary lymph nodes at the lower 2 doses of the 3 administered to arms I and II. At the lower dose, patients receive 3 different peptide pulsed pools, each administered into a different node. At the higher dose, patients receive 3 injections further subdivided into 6 and administered at 6 distinct sites.

          Patients are followed at 2 weeks and then monthly for 3 months.

          1 locations

          United States (1)
          • University of Pennsylvania Cancer Center
            Not specified
            Philadelphia, Pennsylvania, United States, 19104-4283
          Status:
          completed
          Type:
          Interventional
          Phase:
          Start:
          31 March, 1999
          Updated:
          26 February, 2013
          Participants:
          40
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