Dendritic Cell Based Therapy of Malignant Melanoma
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|ClinicalTrials.gov Identifier: NCT00197912|
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : April 26, 2010
|Condition or disease||Intervention/treatment||Phase|
|Advanced Melanoma||Biological: tumor antigen loaded autologous dendritic cells||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Vaccination With Autologous Dendritic Cells Pulsed With Tumor Antigens for Treatment of Patients With Malignant Melanoma. Phase I/II Study|
|Study Start Date :||September 2004|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||April 2010|
- Biological: tumor antigen loaded autologous dendritic cells
DC vaccination regime consists of primary 10 intradermal injections of 1-2 weeks interval (q1w x 4 → q2w x 6). HLA-A2 positive patients are treated with p53, survivin and telomerase peptide-pulsed dendritic cells, and HLA-A2 negative patients are treated with allogeneic tumor lysate pulsed dendritic cells. 50 mg cyclophosphamide (Sendoxan®, Baxter A/S) is administered p.o. twice a day bi-weekly and 200 mg celecoxib (Celebra®, Pfizer) is given p.o. every day. From the 2nd vaccine, 2 MIU Interleukin-2 is administered s.c. on day 2-6.Other Names:
- Dendritic cell vaccine
- Cyclophosphamide, Sendoxan®, Baxter A/S
- Celecoxib, Celebra®, Pfizer
- Interleukin-2, Proleukin®, Chiron B.V.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|