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Natural Dendritic Cells for Immunotherapy of Chemo-naive Metastatic Castration-resistant Prostate Cancer Patients

NCT02692976 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2019-11-14

No results posted yet for this study

Summary

Prostate cancer is the only type of cancer in which conventional dendritic cells (DC) treatment has a beneficial effect on the overall survival. In this study investigators aim to show immunologic efficacy of tumor-peptide loaded natural DC in metastatic castration-resistant prostate cancer patients (mCRPC).

The immunomonitoring will include:

1. functional response and tetramer analysis of delayed-type hypersensitivity infiltrating lymphocytes against tumor peptides and
2. type I interferon (IFN) gene expression in peripheral blood mononuclear cells, and
3. proliferative, effector cytokine- and humoral responses to keyhole limpet hemocyanin, a immunogenic protein providing T cell help.

The secondary objectives are the safety and feasibility of natural DC vaccinations, the influence on the quality of life during treatment with natural DC, and the clinical efficacy of treatment.

Conditions

  • Prostatic Neoplasms
  • Immunotherapy
  • Dendritic Cells
  • Vaccines

Interventions

BIOLOGICAL

mDC vaccination

Intranodal mDC vaccination

BIOLOGICAL

pDC vaccination

Intranodal pDC vaccination

BIOLOGICAL

mDC and pDC vaccination

Intranodal mDC/pDC vaccination

Sponsors & Collaborators

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Winald R Gerritsen, MD PhD · Radboudumc, dep of Medical Oncology

  • Fred Witjes, MD PhD · Radboudumc, dep of Urology

  • Jolanda IM de Vries, PhD · Radboudumc, dep of Tumor Immunology, laboratory study coordinator

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2017-09-30
Completion
2019-03-06

Countries

  • Netherlands

Study Locations

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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 NCT02692976 on ClinicalTrials.gov