CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
vaccine vehicle only +1 morebiological
Likely dose
DC/LNCaP, DC/LNCaP-M1, or DC/KLH administered by subcutaneous injectionAI-extracted
Key inclusion· 6
  • ✓Histologically confirmed prostate carcinoma
  • ✓Progressive disease with rising PSA on 3 occasions, either despite castrate testosterone levels (below 50 ng/dl) or after definitive local therapy (prostatectomy or radiation)
  • ✓3 rising PSA values at least 2 weeks apart
  • ✓Karnofsky performance status 70-100%
Key exclusion· 10
  • ✕Active CNS metastases
  • ✕Prior autologous or allogeneic tumor vaccines
  • ✕More than 2 prior chemotherapy regimens
  • ✕NYHA class III/IV cardiac status, active angina, clinically significant cardiac arrhythmia, or myocardial infarction within 6 months

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

Search/NCT00289341
NCT00289341Phase 2Completed
CompareCT.gov

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

Rockefeller University·interventional·Posted Feb 9, 2006·Updated Jan 18, 2013

In Brief

A Phase 2 clinical trial evaluating vaccine vehicle only and DC/LNCaP for Prostate Cancer. Completed, enrolled 24 participants across 1 site.

Detailed Summary

The purpose of this study is to assess the safety and activity of a type of vaccine as immune therapy for prostate cancer. This vaccine will be made for each participant's own immune cells (called dendritic cells) obtained by blood donation. Dendritic cells are immune cells, whose role is to identify foreign antigens (bacteria, viruses, or tumor cells, for example) in the body and to activate other cells of the immune system to mount an attack on that foreign antigen. Each participant will be randomized into either Arm 1 (experimental treatment only) or Arm 2 (placebo first, then the experimental treatment). Participants will be given the vaccine and three boosters as an injection. After the placebo phase, each participant in Arm 2 will crossover to the treatment phase so that all participants will eventually receive the experimental treatment.

Study Details

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

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 9, 2006
Enrollment StartMar 1, 2002
Primary CompletionNov 1, 2008
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 20.4 years ago

Interventions

vaccine vehicle onlybiological

Subcutaneous injection of vaccine vehicle only (5% DMSO in normal saline), followed by cross-over to Arm 1 design.

DC/LNCaPbiological

Subcutaneous injection of DC/LNCaP, DC/LNCaP-M1, DC/KLH