Dendritic Cell Vaccination and Docetaxel for Patients With Prostate Cancer

NCT ID: NCT01446731

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2015-08-31

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.

Conditions

Prostatic Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A

DC vaccine (mRNA transfected dendritic cell) + Docetaxel

Group Type: EXPERIMENTAL

mRNA transfected dendritic cell

Intervention Type: BIOLOGICAL

Autologous monocytes are matured into dendritic cells which are then transfected with mRNA from PSA, PAP, survivin and hTERT.

5x 10e6 DCs are given as intradermal injections in the groin Day 8 and Day 15 in a 3 week period repeated 4 times and thereafter Day 8 in a 3 week period until progression (no maximum duration).

Docetaxel

Intervention Type: DRUG

Docetaxel 75 mg/m2 is given as an intravenous injection Day 1 every three weeks in a maximum of 12 cycles (1 cycle = 3 weeks).

Arm B

Docetaxel alone

Group Type: ACTIVE_COMPARATOR

Docetaxel

Intervention Type: DRUG

Docetaxel 75 mg/m2 is given as an intravenous injection Day 1 every three weeks in a maximum of 12 cycles (1 cycle = 3 weeks).

Interventions

mRNA transfected dendritic cell

Autologous monocytes are matured into dendritic cells which are then transfected with mRNA from PSA, PAP, survivin and hTERT.

5x 10e6 DCs are given as intradermal injections in the groin Day 8 and Day 15 in a 3 week period repeated 4 times and thereafter Day 8 in a 3 week period until progression (no maximum duration).

Intervention Type: BIOLOGICAL

Docetaxel

Docetaxel 75 mg/m2 is given as an intravenous injection Day 1 every three weeks in a maximum of 12 cycles (1 cycle = 3 weeks).

Intervention Type: DRUG

Other Intervention Names

taxotere

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Inge Marie Svane

OTHER

Sponsor Role: lead

Responsible Party

Inge Marie Svane

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Per Kongsted, MD

Role: PRINCIPAL_INVESTIGATOR

CCIT / Department of Oncology, Herlev Hospital

Locations

Center for Cancer Immune Therapy, Dept. of Haematology/Oncology

Copenhagen, Herlev, Denmark

Department of Oncology, Herlev Hospital

Herlev, , Denmark

Countries

Denmark

Other Identifiers

UR1121

Identifier Type: -

Identifier Source: org_study_id