CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 29 enrolled
Drug / intervention
Peptide Vaccine +1 morebiological
Likely dose
Peptide Vaccine 100 mcgfrom 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/NCT00694551
NCT00694551N/ACompleted

Pilot Immunotherapy Study of Combination PSMA and TARP Peptide With Poly IC-LC Adjuvant in HLA-A2 (+) Patients With Elevated PSA After Initial Definitive Treatment

H. Lee Moffitt Cancer Center and Research Institute·interventional·Posted Jun 10, 2008·Updated Oct 4, 2019

In Brief

A clinical study evaluating Peptide Vaccine and Poly IC-LC for Prostate Cancer. Completed, enrolled 29 participants across 2 sites in 2 countries.

Detailed Summary

Pilot Immunotherapy Study of Combination Prostate Specific Membrane Antigen (PSMA) and T-cell receptor γ alternate reading frame protein (TARP) Peptide With Poly IC-LC Adjuvant in Human Leukocyte Antigens (HLA)-A2 (+) Patients With Elevated prostatic specific antigen (PSA) After Initial Definitive Treatment The purpose of the study is to see if the PSMA/TARP proteins in the vaccine, along with the Hiltonol, can arouse and train the immune system to kill the prostate cancer cells. Prostate cancer is the most common cancer and is the second leading cause of cancer deaths in U.S. males. It is curable when it is confined to the prostate (kept from spreading) using surgery or radiation treatments. In some patients the cancer can come back after these treatments. Treatment options for prostate cancer that comes back include procedures or medications which may have significant risks and side effects. Another plan is being looked at that uses the body's immune system to attack prostate cancer cells. A vaccine has been developed that has proteins found in prostate cancer cells. One of the proteins is called PSMA and the other is called TARP. In addition to these proteins, another substance called Poly IC-LC (Hiltonol) will be added to the vaccine to boost its ability to start the immune system.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesPuerto Rico, United States

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 10, 2008
Enrollment StartDec 2, 2008
Primary CompletionFeb 28, 2013
Study CompletionDec 6, 2018
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 18.1 years ago

Interventions

Peptide Vaccinebiological

Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment.

Poly IC-LCdrug

Administered subcutaneously, one 2 mg/ml vial,(divided into two equal portions for each injection site).