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Phase I Clinical Trial of Cryoimmunotherapy Against Prostate Cancer

NCT02423928 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2019-10-25

No results posted yet for this study

Summary

20 patients with invasive castration resistant prostate cancer and radiologically verified metastases will be enrolled into the Phase I Clinical Trial. The trial is a dendritic cell based immunotherapy. Autologous dendritic cells will be obtained by leukapheresis and elutriation and stimulation by cytokines. The induced dendritic cells will have to pass viability, immunophenotyping and sterility criteria and will be injected into a cryoablated region of the primary prostate cancer tumor. The treatment is supplemented by immunomodulatory regimens.

Conditions

Interventions

BIOLOGICAL

Dendritic cell based cryoimmunotherapy

Autologous dendritic cells will be obtained following leukapheresis and cytokine induction and will be injected into cryoablated prostate cancer tissue under ultrasound guidance.

DRUG

Cyclophosphamide

Low-dose cyclophosphamide will be given metronomically for the purpose of selective inhibition of T regulatory cells for 6 months following start of treatment.

DRUG

ipilimumab

The antibody and immune checkpoint inhibitor ipilimumab (Yervoy) will be given for the last 10 patients enrolled into the study in addition to cryoimmunotherapy and low-dose cyclophosphamide.

Sponsors & Collaborators

  • Haukeland University Hospital

    collaborator OTHER

  • Norwegian Radium Hospital

    collaborator OTHER

  • Alden Cancer Therapy II

    lead INDUSTRY

Principal Investigators

  • Christian Beisland, MD PhD · Bergen Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2019-08-16
Completion
2019-08-16

Countries

  • Norway

Study Locations

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Drugs
Diseases

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 NCT02423928 on ClinicalTrials.gov