Status:
COMPLETED
Dendritic Cell Vaccination and Docetaxel for Patients With Prostate Cancer
Lead Sponsor:
Inge Marie Svane
Conditions:
Prostatic Neoplasms
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
This is a randomized phase II trial including 40 patients with castration resistant metastatic cancer prostate (CRMPC). Patients will be randomized between treatment with a dendritic cell vaccine plu...
Detailed Description
Treatment in details: Dendritic cell (DC) vaccination The DC vaccine consists of adherent monocytes collected by leukapheresis. Monocytes are stimulated with GM-CSF and IL-4, and IL-1β, TNFα, IL-6 an...
Eligibility Criteria
Inclusion
- Histological verified CRMPC in progression, defined by
- RECIST-criteria and/or
- PSA increase to more than baseline in two consecutive measurements
- Treatment with Docetaxel is indicated
- Age \> 18 years old
- ECOG performance status ≤2
- Life expectancy \> 3 months
- Normal organ function
Exclusion
- Other malignant tumors
- Severe heard or lung disorders
- Infection with HIV, hepatitis, tuberculosis.
- Severe allergy or previous anaphylactic reactions
- Active autoimmune disease
- Treatment with immunosuppressive drugs (including prednisolon, methotrexate)7. Co-treatment with other experimental treatments, other antineoplastic treatment.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT01446731
Start Date
October 1 2011
End Date
August 1 2015
Last Update
July 3 2024
Active Locations (2)
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1
Center for Cancer Immune Therapy, Dept. of Haematology/Oncology
Copenhagen, Herlev, Denmark, 2730
2
Department of Oncology, Herlev Hospital
Herlev, Denmark, 2730