Dendritic Cell Based Therapy of Malignant Melanoma
|Advanced Melanoma||Biological: tumor antigen loaded autologous dendritic cells||Phase 1 Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Vaccination With Autologous Dendritic Cells Pulsed With Tumor Antigens for Treatment of Patients With Malignant Melanoma. Phase I/II Study|
- Primary aim of the study is to evaluate tolerability and safety of the treatment [ Time Frame: weekly the first four weeks thereafter biweekly ]
- Secondary aims: evaluation of treatment induced immune response and clinical response. [ Time Frame: after 8 and 16 weeks ]
|Study Start Date:||September 2004|
|Study Completion Date:||April 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
Biological: tumor antigen loaded autologous dendritic cells
- Dendritic cell vaccine
- Cyclophosphamide, Sendoxan®, Baxter A/S
- Celecoxib, Celebra®, Pfizer
- Interleukin-2, Proleukin®, Chiron B.V.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00197912
|Department of Oncology, Copenhagen University Hospital, Herlev|
|Herlev, Denmark, 2970|
|Principal Investigator:||Inge Marie Svane, MD, PHD||Department of Oncology, Copenhagen University Hospital, Herlev, Herlev Ringvej 75, DK-2760 Herlev, Denmark|