Melanoma (Skin) Clinical Trial
Official title:
A Dose Ranging Trial of MART-1/gp100/Tyrosinase/NY-ESO-1 Peptide-Pulsed Dendritic Cells Matured Using Cytokines With Autologous Lymphocyte Infusion With or Without Escalating Doses of Fludarabine for Patients With Chemotherapy-naive Metastatic Melanoma
This is a randomized, controlled, multicenter, dose-escalation study of fludarabine.
Patients are randomized to 1 of 2 treatment arms.
The purpose of this study is to find out what side effects are caused in this study and
whether Fludarabine with the dendritic cell vaccine (DC vaccine) can increase the ability of
the immune system to recognize melanoma.
This is a dose ranging study of intranodal administration of autologous dendritic cells (DC)
pulsed with tumor antigen class I peptides derived from MART-1 (26-35) (27L), gp100 (209-217
(210M), gp100 280-288 (288V), NY-ESO-1 157-165 (165V) and tyrosinase 207-215 as well as
class II MART-1 (51-73), NY-ESO-1 (119-143), MAGE-3 (243-258) and tyrosinase (450-462)
peptides preceded by Autologous Lymphocyte Infusion (ALI) and one of two doses of
Fludarabine. The nine or ten amino acid peptides representing HLA-A2 restricted T cell
epitopes of MART-1, gp100, NY-ESO-1 and tyrosinase will be pulsed onto autologous dendritic
cells produced by incubation of peripheral blood mononuclear cells obtained by apheresis
with interleukin-4 (IL-4) and GM-CSF and pulsed with four helper peptides then matured with
a cytokine cocktail including TNF-a, IL-6, IL-1b and PGE2. Melanoma antigen peptide-pulsed
dendritic cells will be administered at a total dose of 10 million cells each for four
intranodal injections to patients with chemotherapy-naïve metastatic melanoma.
DC matured with a cytokine cocktail and pulsed with class I and II peptides will be injected
intranodally, weekly for two doses, then every two weeks for two doses, for a total of four
injections to each cohort.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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