NCT00852007

A Study Evaluating Vaccination of Prostate Cancer Patients With Self Dendritic Cells Expressing MUC1

A Phase I/II Study Evaluating the Safety and Efficacy of Vaccination With Autologous Dendritic Cells Loaded With Tn-MUC1 Peptide in Patients With Non-Metastatic Androgen Independent Prostatic Adenocarcinoma.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Hamilton Health Sciences Corporation · Academic / Other
• Sex: Male
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This study investigates the use of the patients own immune cells to treat prostate cancer. Cells are taken from the patient and grown in the laboratory to become specialized immune cells called dendritic cells. Dendritic cells instruct other immune cells to recognize and attack foreign substances such as bacteria, viruses, or abnormal proteins on cancer cells. A protein called Tn-MUC-1 is added to the cells.This protein is present on prostate cancer cells. The modified cells are injected back into the patient, with the intention that the dendritic cells will instruct other immune cells to attack the prostate cancer cells.

Detailed description

Patients undergo one standard apheresis to harvest peripheral mononuclear cells for dendritic cell vaccine preparation. The modified cells (vaccine) are frozen so that multiple injections may be given. Patients my receive up to 5 injections. The vaccine is given either intradermally or into a lymph node. Patients will undergo blood sample collection for immune response studies on the day of treatment and 2 weeks following treatment.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
BIOLOGICAL	DC-Tn-MUC1: autologous dendritic cells expressing Tn-MUC1	1.2 x 10e7 dendritic cells per dose. One dose delivered intradermally (i.d.) and into a node (i.n.). Two weeks after this,two injections i.d. 2 weeks apart. Optional booster injections at 6 (i.d. and i.n.) and and 12 months (i.d.).

Timeline

• Start date: 2009-02-01
• Primary completion: 2014-02-01
• Completion: 2016-02-01
• First posted: 2009-02-26
• Last updated: 2016-09-15

Locations

1 site across 1 country: Canada