Status:
COMPLETED
Dendritic Cell Based Therapy of Malignant Melanoma
Lead Sponsor:
Herlev Hospital
Conditions:
Advanced Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00197912
Start Date
September 1 2004
End Date
April 1 2010
Last Update
April 26 2010
Active Locations (1)
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1
Department of Oncology, Copenhagen University Hospital, Herlev
Herlev, Denmark, 2970