Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00061035
Status:
COMPLETED
Last Update Posted:
2008-08-28
First Post:
2003-05-20
Brief Title:
Evaluation of Transgenic Lymphocyte Immunization Vaccine in Subjects With Prostate Adenocarcinoma
Sponsor:
Cosmo Bioscience
Organization:
Cosmo Bioscience
Study Overview
Official Title:
A Phase 1 Evaluation of Transgenic Lymphocyte Immunization Vaccine in Subjects With Prostate Adenocarcinoma
Status:
COMPLETED
Status Verified Date:
2008-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 patients immune system react against telomerase an enzyme expressed in prostate cancer cells
Detailed Description:
The goal of the study is to determine the safety feasibility and tolerability of transgenic lymphocyte immunization TLI In this process patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None