Dendritic Cell Vaccination in Combination With Docetaxel for Patients With Cancer Prostate - a Randomized Phase II Study
18 Years
N/A
Male
Prostatic Neoplasms
Trial Information
Dendritic Cell Vaccination in Combination With Docetaxel for Patients With Cancer Prostate - a Randomized Phase II Study
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 and PGE2
are used for further maturation.
DCs are transfected with PSA, PAP, survivin and hTERT mRNA. DC vaccines will only be given
to patients in ARM A
Docetaxel:
Docetaxel will be given as an i.v. infusion every third week, 75 mg/m2 according to standard
treatment. Patients will be pretreated with prednisolon before infusion with Docetaxel.
Continuous treatment with prednisolon will not be administered.
Treatment schedule:
The DC vaccination will be administered once a week in two out of three weeks for the first
12 weeks. After 12 weeks the DC vaccination will be given once every three weeks as long as
Docetaxel is given. If the disease does not progress but the patient stop treatment with
Docetaxel (because of side effects) the vaccine treatment can continue until disease
progression.
Evaluation in details:
Immunological evaluation:
Blood tests:
100 ml blood will be drawn from the patient together with the first (baseline), the third
and the fourth infusion of Docetaxel, and every third month thereafter.
DTH:
DTH with 3 i.d. injections consisting of media (neg. test), naked DCs and mRNA transfected
DCs will be performed at baseline (together with 1st vaccine), together with the 5th vaccine
and after three months of treatment (8th vaccine). 48 hours after the DTH at 5th vaccine a
biopsy will be taken from the DTH area.
Clinical evaluation:
PSA:
Patients will be evaluated with PSA measurements during the treatment. All patients will
receive at least 4 treatments with Docetaxel even if PSA is rising.
18F-NaF ("bone") PET/CT scan: All patients will have a bone-PET/CT scan at baseline. For
patients with measurable lesions a PET/CT scan will be performed every three months.
Inclusion Criteria:
1. Histological verified CRMPC in progression, defined by
1. RECIST-criteria and/or
2. PSA increase to more than baseline in two consecutive measurements
2. Treatment with Docetaxel is indicated
3. Age > 18 years old
4. ECOG performance status ≤2
5. Life expectancy > 3 months
6. Normal organ function
Exclusion Criteria:
1. Other malignant tumors
2. Severe heard or lung disorders
3. Infection with HIV, hepatitis, tuberculosis.
4. Severe allergy or previous anaphylactic reactions
5. Active autoimmune disease
6. Treatment with immunosuppressive drugs (including prednisolon, methotrexat)7.
Co-treatment with other experimental treatments, other antineoplastic treatment.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Immunological response
Outcome Description:
The induction of vaccine specific immune responses will be assessed
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Eva Ellebæk, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
CCIT / Department of Oncology, Herlev Hospital
Authority:
Denmark: Danish Dataprotection Agency
Study ID:
UR1121
NCT ID:
NCT01446731
Start Date:
October 2011
Completion Date:
October 2012
Related Keywords:
- Prostatic Neoplasms
- Prostate cancer
- Neoplasms
- Prostatic Neoplasms
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