Finding studies
Finding studies
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Lead
Providence Cancer Center, Earle A. Chiles Research Institute
With
OBJECTIVES: Primary * Determine the toxicity and immune effects of vaccination comprising modified gp100 peptide (gp100:209-217\[210M\]), Montanide ISA-51, and keyhole limpet hemocyanin followed by peripheral blood mononuclear cell reinfusion after treatment-induced lymphopenia with fludarabine in patients with unresectable or metastatic melanoma. * Determine the induction of antigen-specific T-cell responses in patients treated with this regimen. * Determine the kinetics and duration of immune response in patients treated with this regimen. * Compare the immunologic effects of this regimen in these patients with historical results. Secondary * Compare 2 different dosing schedules of fludarabine, in terms of induction of lymphopenia and granulocytopenia and on the induction of a specific immune response to this vaccine, in these patients. OUTLINE: This is a pilot, randomized study. Patients are randomized to 1 of 2 treatment arms. Within 2 weeks before the start of fludarabine, all patients undergo leukapheresis over 4-6 hours for the collection of peripheral blood mononuclear cells (PBMCs). * Arm I: Patients receive fludarabine IV over 30 minutes on days 1-5. * Arm II: Patients receive fludarabine as in arm I on days 1, 3, and 5. In both arms, patients receive autologous PBMCs IV over approximately 30 minutes on day 8 and vaccination comprising gp100:209-217(210M) peptide, Montanide ISA-51, and keyhole limpet hemocyanin subcutaneously on days 8, 22, 36, 50, and 64. Patients with stable or responding disease continue to receive vaccination on day 78 and then every 28-31 days for up to 1 year. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 20 patients (10 per treatment arm) will be accrued for this study within 2 years.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
