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Vaccination With Autologous Dendritic Cells Pulsed With Tumor Antigens for Treatment of Patients With Malignant Melanoma. Phase I/II Study

Phase 1/Phase 2
18 Years
Not Enrolling
Advanced Melanoma

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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:


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:


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


Denmark: Danish Medicines Agency

Study ID:




Start Date:

September 2004

Completion Date:

April 2010

Related Keywords:

  • Advanced Melanoma
  • dendritic cell
  • cancer vaccine
  • cyclophosphamide
  • melanoma
  • Melanoma