PH I &II: AUTOLOGOUS DENDRITIC CELLS INDUCTION OF ANTITUMOR IMMUNITY

$40,907M01FY2000RRNIH

Duke University, Durham NC

Investigators

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Abstract

The protocol is for patients that are between the ages of 18-75, male or female of any ethnic background - although this disease is predominantly Caucasian. The patients that are candidates for this protocol are diagnosed melanoma with first order lymph node involvement that are surgically free of disease. This is an active immunotherapy that is administered intravenously at monthly intervals for four administrations. The patients are admitted to the GCRC for the autologous dendritic cell pulsed with either the crude melanoma tumor lysate or gp100 peptide and tyrosinase peptide followed by subcutaneous b.i.d. IL-2 for three days. The primary objective of this protocol is to evaluate the toxicity and the in-vitro and in-vivo immunological responses of melanoma patients receiving autologous dendritic cells pulsed with gp-100 and tyrosinase peptides or autologous tumor cell lysates. The secondary objective is to determine time to recurrence and survival.

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