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Dendritic Cell Vaccination and Docetaxel for Patients With Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01446731
Recruitment Status : Completed
First Posted : October 5, 2011
Last Update Posted : August 16, 2016
Sponsor:
Information provided by (Responsible Party):
Inge Marie Svane, Herlev Hospital

Study Description
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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 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 or disease Intervention/treatment Phase
Prostatic Neoplasms Biological: mRNA transfected dendritic cell Drug: Docetaxel Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dendritic Cell Vaccination in Combination With Docetaxel for Patients With Cancer Prostate - a Randomized Phase II Study
Study Start Date : October 2011
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Immunological response [ Time Frame: 2 years ]
    The induction of vaccine specific immune responses will be assessed


Secondary Outcome Measures :
  1. Clinical response [ Time Frame: 2 years ]
    Clinical response will be assessed using PSA measurements, pain response and PET/CT scans (according to RECIST)

  2. Toxicity [ Time Frame: 2 years ]
  3. Time to progression [ Time Frame: 4 years ]
  4. Overall survival [ Time Frame: 4 years ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01446731


Locations
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Denmark
Center for Cancer Immune Therapy, Dept. of Haematology/Oncology
Copenhagen, Herlev, Denmark, 2730
Department of Oncology, Herlev Hospital
Herlev, Denmark, 2730
Sponsors and Collaborators
Inge Marie Svane
Investigators
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Principal Investigator: Per Kongsted, MD CCIT / Department of Oncology, Herlev Hospital
More Information
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Responsible Party: Inge Marie Svane, Professor, Herlev Hospital
ClinicalTrials.gov Identifier: NCT01446731    
Other Study ID Numbers: UR1121
First Posted: October 5, 2011    Key Record Dates
Last Update Posted: August 16, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Inge Marie Svane, Herlev Hospital:
Prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
 Prostatic Diseases
Male Urogenital Diseases
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action