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Dendritic Cell Vaccination and Docetaxel for Patients With Prostate Cancer

NCT01446731 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2024-07-03

Study results available
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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.

Conditions

  • Prostatic Neoplasms

Interventions

BIOLOGICAL

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).

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).

Sponsors & Collaborators

  • Inge Marie Svane

    lead OTHER

Principal Investigators

  • Per Kongsted, MD · CCIT / Department of Oncology, Herlev Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01446731 on ClinicalTrials.gov