Vaccine Therapy in Treating Patients With Stage IV Melanoma
RATIONALE: Vaccines made from a person's tumor cells and white blood cells may help the body build an effective immune response to kill tumor cells.
PURPOSE: This phase I/II trial is studying the side effects of vaccine therapy and to see how well it works in treating patients with stage IV melanoma.
Biological: autologous tumor cell vaccine
Biological: therapeutic autologous dendritic cells
|Study Design:||Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Vaccination of Stage IV Cutaneous Melanoma Patients With Mature, Autologous Monocyte-Derived Dendritic Cells Transfected With Unselected Autologous Amplified Tumor-RNA|
- Safety [ Designated as safety issue: Yes ]
- Immunogenicity [ Designated as safety issue: No ]
- Objective tumor response [ Designated as safety issue: No ]
- Time to disease progression [ Designated as safety issue: No ]
- Progression-free interval [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
|Study Start Date:||April 2005|
- 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 study.
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 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00126685
|Dermatologische Klinik mit Poliklinik - Universitaetsklinikum Erlangen|
|Erlangen, Germany, D-91052|
|Study Chair:||Gerold Schuler||Dermatologische Klinik MIT Poliklinik-Universitaetsklinikum Erlangen|