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Dendritic Cell Vaccine Study (DC/PC3) for Prostate Cancer

NCT00345293 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2016-04-18

Study results available
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Summary

The purpose of this study is to assess the safety and activity of DC/PC3, a dendritic cell vaccine used as immunotherapy for prostate cancer. The vaccine is made with each participants' own immune cells obtained through blood donation. Dendritic cells are known to activate other immune cells such as T cells, that are able to mount an attack against cancer cells. The dendritic cell vaccine will be administered as injections every 2 weeks over a course of 2 months.

Conditions

Interventions

BIOLOGICAL

autologous dendritic cell vaccine (DC/PC3)

ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and pulsed with apoptotic PC3-M1 cells(control apoptotic cells) and pulsed with KLH (control antigen). maximum dose of DC/PC3 that we are able to generate from their initial leukaphereses product, up to a maximum of 10 x 106 DCs. Doses in the range of 105 to 10 x 106 DCs have been used clinically without toxicity

Sponsors & Collaborators

Principal Investigators

  • Robert B Darnell, MD PHD · Rockefeller University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2013-12-31
Completion
2015-03-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT00345293 on ClinicalTrials.gov