Advanced Melanoma Clinical Trial
Official title:
Vaccination With Autologous Dendritic Cells Pulsed With Tumor Antigens for Treatment of Patients With Malignant Melanoma. Phase I/II Study
The aim of the study is to show if vaccination with autologous dendritic cells pulsed with peptides or tumor lysate in combination with adjuvant cytokines and Cyclophosphamide can induce a measurable immune response in patients with metastatic malignant melanoma, and to evaluate the clinical effect (objective response rate) of the vaccination regime.
Eligible patients receive vaccination with tumor antigen pulsed autologous monocyte-derived
mature dendritic cells with a fixed interval. The dendritic cells are generated from
leukapheresis products and frozen after antigen loading.
HLA A2 positive patients are treated with PADRE and oncopeptide pulsed DC; p53, survivin and
telomerase peptides. HLA A2 negative patients are treated with KLH and tumorlysate pulsed
DC; autologous or allogeneic. Each patient is given 6 immunizations with at least 5x106
peptide/lysate pulsed autologous DC. Vaccination 1-4 is given weekly and 4-6 at 2-week
intervals. Those patients who exhibit stable disease, partial response or complete response
after 6 injections will be given 4 more vaccinations at 2-week interval. The vaccine is
applied by intradermal injection near the inguinal region.
IL-2 2 MIU s.c. day 2-6, Cyclophosphamide (Sendoxan®, Baxter A/S) 50 mg twice a day
bi-weekly and 200 mg Celecoxib (Celebra®, Pfizer) daily are used. Scans and re-staging tests
are performed at scheduled intervals throughout the study.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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