CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 13 enrolled
Drug / intervention
autologous dendritic cell vaccine (DC/PC3)biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00345293
NCT00345293Phase 2Completed

A Phase I/II Study of Autologous Dendritic Cells Pulsed With Apoptotic Tumor Cells (DC/PC3) Administered Subcutaneously to Prostate Cancer Patients.

Rockefeller University·interventional·Posted Jun 28, 2006·Updated Apr 18, 2016

In Brief

A Phase 2 clinical trial evaluating autologous dendritic cell vaccine (DC/PC3) for Prostate Cancer. Completed, enrolled 13 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 28, 2006
Enrollment StartJun 1, 2006
Primary CompletionDec 1, 2013
Study CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 7.5 yearsPosted 20.0 years ago

Interventions

autologous dendritic cell vaccine (DC/PC3)biological

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