A Phase 1/2 interventional study of tumor antigen loaded autologous dendritic cells in Advanced Melanoma, sponsored by Herlev Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-04-26.
Sponsored by Herlev Hospital · Phase 1/2, Interventional, and Treatment
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.
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's enrollment of 25 is below the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →Herlev Hospital is the lead sponsor of 195 studies on the registry; 25 are open to participants now.
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Exclusion Criteria:
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.
Also known as: 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
This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.
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Herlev Hospital