Dendritic Cell Vaccination and Docetaxel for Patients With Prostate Cancer

This study is currently recruiting participants.
Verified January 2014 by Herlev Hospital
Sponsor:
Information provided by (Responsible Party):
Inge Marie Svane, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT01446731
First received: October 2, 2011
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

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 evlauated 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.


Condition Intervention Phase
Prostatic Neoplasms
Biological: mRNA transfected dendritic cell
Drug: Docetaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dendritic Cell Vaccination in Combination With Docetaxel for Patients With Cancer Prostate - a Randomized Phase II Study

Resource links provided by NLM:


Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • Immunological response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The induction of vaccine specific immune responses will be assessed


Secondary Outcome Measures:
  • Clinical response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Clinical response will be assessed using PSA measurements, pain response and PET/CT scans (according to RECIST)

  • Toxicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Time to progression [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: October 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
DC vaccine (mRNA transfected dendritic cell) + Docetaxel
Biological: mRNA transfected dendritic cell

Autologues 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).

Drug: 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).
Other Name: taxotere
Active Comparator: Arm B
Docetaxel alone
Drug: 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).
Other Name: taxotere

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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, methotrexat)7. Co-treatment with other experimental treatments, other antineoplastic treatment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01446731

Contacts
Contact: Inge Marie Svane, Prof, MD +45 38683868 imsv@heh.regionh.dk
Contact: Per Kongsted, MD +45 38683868 per.kongsted@regionh.dk

Locations
Denmark
Center for Cancer Immune Therapy, Dept. of Haematology/Oncology Recruiting
Copenhagen, Herlev, Denmark, 2730
Contact: Inge Marie Svane, Prof, MD    +45 38683868    imsv@heh.regionh.dk   
Contact: Per Kongsted, MD    +45 38683868    per.kongsted@regionh.dk   
Department of Oncology, Herlev Hospital Recruiting
Herlev, Denmark, 2730
Contact: Inge Marie Svane, Prof, MD    +45 38683868      
Contact: Eva Ellebæk, MD    +45 38683868    evaell02@heh.regionh.dk   
Sponsors and Collaborators
Inge Marie Svane
Investigators
Principal Investigator: Per Kongsted, MD CCIT / Department of Oncology, Herlev Hospital
  More Information

No publications provided

Responsible Party: Inge Marie Svane, Professor, Herlev Hospital
ClinicalTrials.gov Identifier: NCT01446731     History of Changes
Other Study ID Numbers: UR1121
Study First Received: October 2, 2011
Last Updated: January 29, 2014
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: Ethics Committee

Keywords provided by Herlev Hospital:
Prostate cancer

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014