Vaccination With Autologous Dendritic Cells Pulsed With Tumor Antigens for Treatment of Patients With Malignant Melanoma. Phase I/II Study
18 Years
N/A
Both
Advanced Melanoma
Trial Information
Vaccination With Autologous Dendritic Cells Pulsed With Tumor Antigens for Treatment of Patients With Malignant Melanoma. Phase I/II Study
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.
Inclusion Criteria:
- Histologically proven progressive metastatic or locally advanced melanoma
- No standard treatment indicated
- Age: > 18
- WHO-Performance Status 0-1
- At least tone measurable tumor lesions according to the RECIST criteria.
- Life expectancy more than 3 months
- Acceptable CBC and blood chemistry results
- Written informed consent
Exclusion Criteria:
- Patients with a history of any other neoplastic disease less than 5 years ago
(excepting treated carcinomas in situ of the cervix and basal/squamous cell
carcinomas of the skin).
- Patients with metastatic disease in the central nervous system (CNS).
- Patients with other significant illness including severe allergy, asthma, angina
pectoris or congestive heart failure.
- Patients with acute or chronic infection including HIV, hepatitis and tuberculosis.
- Patients who are pregnant.
- Patients who have received antineoplastic therapy including chemotherapy or
immunotherapy less than 4 weeks before beginning the trial.
- Patients who receive corticosteroids or other immunosuppressive agents.
- Baseline serum LDH greater than 2.5 times the upper limit of normal.
- Patients with active autoimmune diseases such as lupus erythematosus, rheumatoid
arthritis or thyroiditis.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Primary aim of the study is to evaluate tolerability and safety of the treatment
Outcome Time Frame:
weekly the first four weeks thereafter biweekly
Safety Issue:
Yes
Principal Investigator
Inge Marie Svane, MD, PHD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Department of Oncology, Copenhagen University Hospital, Herlev, Herlev Ringvej 75, DK-2760 Herlev, Denmark
Authority:
Denmark: Danish Medicines Agency
Study ID:
MM0413
NCT ID:
NCT00197912
Start Date:
September 2004
Completion Date:
April 2010
Related Keywords:
- Advanced Melanoma
- dendritic cell
- cancer vaccine
- cyclophosphamide
- melanoma
- Melanoma
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