Mature Dendritic Cell Vaccination Against gp100 in Patients With Advanced Melanoma
Eligible patients that provide written informed consent will undergo apheresis to collect
blood mononuclear cells for vaccine production. All patients will be given cyclophosphamide
300mg/m2 IV three days prior to vaccine dose #1 in order to deplete regulatory T cells. All
patients will receive mature DC for each dose of vaccine. For each dose all patients will
receive autologous dendritic cells pulsed with 2 gp100 melanoma peptides (G209-2M and
G280-9V) plus up to an additional 10 unique melanoma tumor-specific peptides. All patients
will receive booster doses with mature DC. The DC vaccine will be given intravenously every
three weeks for a total of six vaccine doses. Peripheral blood (16 ml) will be taken weekly
to monitor the immune response to each peptide by tetramer assay. Apheresis is repeated
after vaccine dose #3 and dose #6 in order to collect PBMC for immune monitoring. Restaging
is performed after three and six vaccine doses. Patients with stable disease or better
(partial response/complete response) after six doses will be eligible to receive additional
vaccinations as maintenance therapy every 2 months until progression.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the immunological response based on measuring increased numbers of peptide specific CD8+ T cells as calculated by the tetramer assay.
Starting on Day 0, two tubes will be drawn weekly until Day 64. Thereafter, two tubes will be drawn every 21 days until Day 190. For patients receiving maintenance treatment, blood is drawn every month.
Through completion of treatment
Gerald P. Linette, M.D., Ph.D.
Washington University School of Medicine
United States: Food and Drug Administration
07-0652 / 201103308
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