Clinical trial NCT01446731: Dendritic Cell Vaccination and Docetaxel for Patients With Prostate Cancer
Official title: Dendritic Cell Vaccination in Combination With Docetaxel for Patients With Cancer Prostate - a Randomized Phase II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostatic Neoplasms
Keywords: Prostate cancer
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2011-10-05
Enrollment: 43
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 plus docetaxel and docetaxel alone.

The primary objective is to evaluate the vaccine specific immune response and patients will be evaluated with blood tests and DTH reactions during the treatment course.

Secondary objectives are to evaluate clinical response by objective response (RECIST-criteria, 18F-NaF-PET/CT scan), PSA response, pain response and finally we determine time to progression and overall survival.

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 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.

Eligibility criteria: 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, methotrexate)7. Co-treatment with other experimental treatments, other antineoplastic treatment.

Primary outcomes:
measure: Number of Patients With Immunological Response
timeFrame: 2 years
Secondary outcomes:
measure: Number of Patients With PSA Response
timeFrame: 2 years
measure: Number of Patients With Adverse Event Considered Related to the Dendritic Cell Vaccine
timeFrame: 2 years
measure: Progression-free Survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Center for Cancer Immune Therapy, Dept. of Haematology/Oncology
state: Herlev
city: Herlev
country: Denmark
facility: Department of Oncology, Herlev Hospital
Study officials:
affiliation: CCIT / Department of Oncology, Herlev Hospital
name: Per Kongsted, MD
role: PRINCIPAL_INVESTIGATOR
References: