Vaccination Of HLA-A1 And/Or -A2+ Stage III or IV Melanoma Patients With Tumor Peptide - Loaded Autologous Dendritic Cells That Are Generated In The Absence Or Presence Of CD40 Ligand
- Compare the efficacy of vaccination with autologous dendritic cells pulsed with tumor
and influenza antigen peptides treated with vs without ex vivo CD40-ligand, in terms of
tumor-specific T-cell response, in patients with HLA-A1 and/or HLA-A2.1 positive stage
III or IV melanoma.
- Determine the safety and tolerability of these vaccinations in these patients.
- Determine tumor response and recurrence rates in patients treated with these
OUTLINE: This is an open-label non-randomized study.
- Phase I: Patients undergo leukapheresis for collection of peripheral blood mononuclear
cells (PBMC). PBMC are cultured with sargramostim (GM-CSF) and interleukin-4 to
generate dendritic cells (DCs) on day -9. DCs are pulsed separately with HLA-A1 and
HLA-A2.1-restricted flu matrix peptides derived from melanoma-associated tumor antigens
(MAGE-10.A2, Melan-A, MAGE-3, NY-ESO-1, gp100 antigen, and tyrosinase peptide). Half of
the DCs are treated ex vivo with CD40-ligand. Patients receive the peptide-pulsed DC
vaccinations subcutaneously (SC) on days 1, 14, 42, and 70 in the absence of disease
Patients who show tumor response (at least stable disease) at day 98 progress to phase II of
- Phase II: Patients undergo leukapheresis as in phase I on days 102, 352, and 688.
Patients receive up to 6 additional booster vaccinations SC as in phase I on days 126,
184, 268, 356, 520, and 692.
Patients are followed for 10 years.
PROJECTED ACCRUAL: A total of 8-30 patients will be accrued for this study within 6-12
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Comparison of the efficacy of vaccination with vs without ex vivo CD40-ligand in terms of tumor-specific T-cell response
Dermatologische Klinik MIT Poliklinik-Universitaetsklinikum Erlangen
United States: Federal Government