ClinicalTrialsFinder
TerminatedPhase 1ACTRN12607000450415

A Phase I Clinical Trial of a Christchurch Medical Research Foundation (CMRF)-56+ Blood Dendritic Cell Preparation for the Immunotherapy of Metastatic Hormone Refractory Prostate Cancer

Sponsor

Mater Medical Research Institute

Enrollment

12 participants

Start Date

Sep 1, 2007

Study Type

Interventional

Conditions

Patients with hormone refractory metastatic prostate cancer

Summary

CMRF-56BDC-02 is a therapeutic blood dendritic cell (BDC) vaccine for the treatment of patients with prostate cancer (PC). This study has been designed principally to assess the safety of CMRF-56BDC-02 in PC patients with metastatic hormone refractory disease. Secondary objectives of the study are to evaluate the preliminary efficacy of the vaccine in the induction of an immune response against PC and the evaluation of the disease response to the vaccine in these patients. We will investigate the safety and preliminary effect of three vaccinations with CMRF-56BDC-02, given at monthly intervals. Two doses (low and high dose), given into the skin or veins, will be studied.

Eligibility

Sex: MalesMin Age: 18 YearssMax Age: 80 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests an immune therapy using specially prepared blood dendritic cells for men with advanced prostate cancer that no longer responds to hormone treatment. It is open to men aged 18 to 80 with metastatic, hormone-resistant prostate cancer. Participants will receive dendritic cell injections and be monitored for immune response and cancer progression.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

This is a phase I, dose-finding study of CMRF-56 Blood Dendritic Cell (BDC)-02 vaccination. Twelve patients, from whom the vaccine can successfully be produced, will be recruited. Initially, three sub

This is a phase I, dose-finding study of CMRF-56 Blood Dendritic Cell (BDC)-02 vaccination. Twelve patients, from whom the vaccine can successfully be produced, will be recruited. Initially, three subjects will receive three doses of 1x106 CMRF-56+ Blood Dendritic Cell (BDC), given into the skin (intra-dermal) at monthly intervals. When all three subjects have safely received their second dose of CMRF-56 lood Dendritic Cell (BDC)- 02, a further three subjects will be recruited to receive three doses of 1x107CMRF-56+ Blood Dendritic Cell (BDC), also given into the skin at monthly intervals. When all of these subjects have received their second dose safely, six additional subjects will commence the same protocol as above, however they will receive their vaccines through the veins (intravenously).

Locations(1)

Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12607000450415