Vaccination of Stage IV Cutaneous Melanoma Patients With Mature, Autologous Monocyte-Derived Dendritic Cells Transfected With RNAs Encoding for Mage-3, MelanA, and Survivin Antigens
- Determine the safety and tolerability of vaccination with autologous monocyte-derived
dendritic cells (DC) transfected with RNAs encoding Melan-A, MAGE-3, and survivin
antigens in patients with stage IV cutaneous melanoma.
- Determine whether tumor antigen-specific T-cell responses are induced in patients
treated with this vaccine.
- Determine whether simultaneous loading of DC with keyhole limpet hemocyanin (KLH)
significantly enhances induction of the Melan-A, MAGE-3, and survivin antigens in these
- Determine clinical antitumor activity (e.g., objective tumor response, time to tumor
progression, progression-free interval, and overall survival) in patients treated with
OUTLINE: This is an open-label, nonrandomized study.
- Phase I: Beginning 9-11 days before vaccination, patients undergo leukapheresis for
collection of peripheral blood mononuclear cells (PBMCs). PBMCs are processed for the
generation of dendritic cells (DC) to be used for vaccinations. PBMCs are transfected
with RNAs encoding for Melan-A, MAGE-3, and survivin antigens. DC are pulsed with
keyhole limpet hemocyanin (KLH) for some patients.
Patients receive antigen-pulsed (with or without KLH) DC vaccination subcutaneously (SC) on
days 1, 15, 43, and 71 in the absence of disease progression or unacceptable toxicity.
Patients with stable or responding disease may proceed to the phase II portion of the study.
- Phase II: Patients undergo leukapheresis as in phase I on days 102, 354, and 690.
Patients receive up to 6 additional booster vaccinations SC as in phase I on days 127,
185, 269, 356, 521, 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
Masking: Open Label, Primary Purpose: Treatment
Safety and tolerability at every visit
Dermatologische Klinik MIT Poliklinik-Universitaetsklinikum Erlangen