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Human Telomerase Reverse Transcriptase Messenger RNA (hTERT mRNA) Transfected Dendritic Cell Vaccines

NCT01153113 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2011-12-02

No results posted yet for this study

Summary

The purpose of this research is to develop a new and powerful type of immune therapy for prostate cancer patients. This therapy involves vaccinations with special stimulator cells found in the human body called dendritic cells. These dendritic cells can take up proteins released from cancer cells and present pieces of these proteins to immune cells called T lymphocytes to create a strong stimulatory signal to fight the cancer.

One of these proteins is called telomerase, which is found on prostate cancers and is critically important for prostate cancer cells to grow. However, in most cancer patients, the immune system does not adequately destroy the tumor because the T cells are not stimulated sufficiently. T cells require strong stimulation before they grow and become active against cancer cells.

We have discovered that substances called ribonucleic acids (RNA), which carry the genetic instructions for the production of telomerase, can be used to overcome this problem and stimulate a strong immune response in cancer patients.

In order to test this hypothesis we have designed a clinical study and will enroll patients with metastatic prostate cancer expressing telomerase in order to determine whether or not this vaccine will stimulate T cells, which can recognize and kill prostate tumor cells.

The main objectives of this study are to find out whether injections with dendritic cells grown from blood cells and "pulsed" (mixed together for a short period of time) with RNA derived from the patient's own tumor are:

1. Safe without inducing any major side effects.
2. And effective in boosting the patient body's immunity against telomerase expressing prostate cancer cells.
3. Finally, we will test whether or not tumor shrinkage based on serum PSA levels or on X-ray studies will occur.

We hope that this new form of immune therapy, although in its infancy, will ultimately slow down tumor growth and prolong survival of prostate cancer patients.

Conditions

Interventions

BIOLOGICAL

hTERT mRNA DC

Subjects receive 1x107 cells per infusion administered ID at study week 1, 2, 3, 4, 5, 6 then receive 5x106 cells per infusion administered ID at study weeks 10, 14, 18, 22, 26, 30, 34, 38, 42, 46 and 50.

BIOLOGICAL

hTERT mRNA DC

Subjects receive 1x107 cells per infusion administered ID at study week 1, 2, 3, 4, 5, 6 then receive 1x107 cells per infusion administered ID at study weeks 10, 14, 18, 22, 26, 30, 34, 38, 42, 46 and 50.

Sponsors & Collaborators

  • University of Florida

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2009-12-31
Completion
2010-12-31

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Entities

Diseases

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 NCT01153113 on ClinicalTrials.gov