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| Sponsor: | Cosmo Bioscience |
|---|---|
| Information provided by: | Cosmo Bioscience |
| ClinicalTrials.gov Identifier: | NCT00061035 |
Purpose
Dr. Frederick Millard, MD, Associate Clinical Professor at the UCSD Cancer Center, will be conducting a 12-week study in advanced prostate cancer patients. The study will be held at the UCSD Medical Center and will test an experimental investigational gene therapy vaccine designed to make the patient's immune system react against telomerase, an enzyme expressed in prostate cancer cells.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostatic Neoplasms |
Biological: Transgenic Lymphocyte Immunization Vaccine (TLI) |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study |
| Official Title: | A Phase 1, Evaluation of Transgenic Lymphocyte Immunization Vaccine in Subjects With Prostate Adenocarcinoma |
| Estimated Enrollment: | 18 |
| Study Start Date: | April 2003 |
The goal of the study is to determine the safety, feasibility, and tolerability of transgenic lymphocyte immunization (TLI). In this process patient's lymphocytes are rendered transgenic for a gene coding for selected portion of telomerase an enzyme expressed in the vast majority of cancer cells. Transgenic cells are then returned to the patient to produce an immune response targeted at cancer cells expressing telomerase. The Phase 1 trial will evaluate TLI in patients with advanced, androgen-independent prostate cancer with metastases confined to lymph nodes or bones.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The following categories of subjects with androgen-independent prostate cancer are eligible:
Subjects must meet the following initial laboratory criteria:
Contacts and Locations| United States, California | |
| University of California, San Diego Cancer Center | |
| San Diego, California, United States, 92093-0987 | |
| Principal Investigator: | Frederick E. Millard, M.D | Associate Professor of Medicine at UCSD and Medical Director of the CTO of the UCSD Cancer Center |
More Information
| Study ID Numbers: | TLI-CA-TRT-001 |
| Study First Received: | May 20, 2003 |
| Last Updated: | August 26, 2008 |
| ClinicalTrials.gov Identifier: | NCT00061035 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Prostate Cancer; Immunotherapy |
|
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms |
Genital Diseases, Male Adenocarcinoma Prostatic Neoplasms Neoplasms, Glandular and Epithelial Carcinoma |