Vaccination of Stage IV Cutaneous Melanoma Patients With Mature, Autologous Monocyte-Derived Dendritic Cells Transfected With Unselected Autologous Amplified Tumor-RNA
- Determine the safety and tolerability of vaccine therapy comprising autologous
dendritic cells (DC) transfected with autologous polymerase chain reaction-amplified
tumor RNA in patients with stage IV cutaneous melanoma.
- Determine whether tumor RNA- or tumor antigen-specific T-cell responses are induced in
patients treated with this vaccine.
- Determine whether there are major differences in the immunogenicity of DC transfected
at immature stage or at mature stage in patients treated with this vaccine.
- Determine objective tumor response in patients treated with this vaccine.
- Determine time to disease progression and progression-free interval in patients treated
with this vaccine.
- Determine overall survival of patients treated with this vaccine.
OUTLINE: This is an open-label, nonrandomized study. Patients are sequentially assigned to
receive dendritic cells (DC) transfected at either immature or mature stage.
Approximately 2-3 weeks before leukapheresis, patients undergo surgical excision or biopsy
of the tumor to obtain tumor tissue for RNA isolation. RNA is amplified from the tumor
sample by polymerase chain reaction (PCR). Patients then undergo leukapheresis to harvest
peripheral blood mononuclear cells for the production of DC on day -14 . DC at immature or
mature stage are transfected with autologous PCR-amplified tumor RNA to produce the vaccine.
Patients receive vaccine intradermally (ID) on days 1, 15, 29, 43, 57, and between days
71-74 in the absence of disease progression or unacceptable toxicity. Patients undergo
evaluation between days 71-74. Patients with responding or stable disease or minor disease
progression receive booster vaccine ID on days 99, 127, between days 162-164, on day 205,
between days 253-255, 351-354, 442-444, 533-535, 624-626, and 715-718 in the absence of
disease progression or unacceptable toxicity. Patients also undergo additional leukapheresis
between days 71-74, 351-354, and 715-718. Patients with responding or stable disease may
continue to undergo leukapheresis and receive booster vaccine ID every 12-24 weeks off
After completion of study treatment, patients are followed periodically for up to 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
Dermatologische Klinik MIT Poliklinik-Universitaetsklinikum Erlangen
United States: Federal Government