Evaluation of Transgenic Lymphocyte Immunization Vaccine in Subjects With Prostate Adenocarcinoma

This study has been completed.
Sponsor:
Information provided by:
Cosmo Bioscience
ClinicalTrials.gov Identifier:
NCT00061035
First received: May 20, 2003
Last updated: August 26, 2008
Last verified: August 2008
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, Evaluation of Transgenic Lymphocyte Immunization Vaccine in Subjects With Prostate Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by Cosmo Bioscience:

Estimated Enrollment: 18
Study Start Date: April 2003
Detailed Description:

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
Criteria

Inclusion Criteria:

  • 18 years of age or older, able to understand and sign the informed consent form.
  • HLA-A2 positive.
  • Expected survival ≥ 6 months.
  • Histological evidence of adenocarcinoma of the prostate.
  • (ECOG) Performance status 0, 1 or 2.

The following categories of subjects with androgen-independent prostate cancer are eligible:

  • Progression of bidimensionally measurable disease assessed within 84 days (12 weeks) prior to enrollment.
  • Progression of evaluable but not measurable disease (i.e., bone scan) assessed within 112 days (16 weeks) prior to enrollment.
  • Rising PSA- Rising PSA is defined as at least two consecutive rises in PSA to be documented over a reference value (measure 1). The first rising PSA (measure 2) must be taken at least 7 days after the reference value. A third confirmatory PSA measure is required (2nd beyond the reference level) to be greater than the second measure, and it must be obtained at least 7 days after the 2nd measure. If this is not the case, a fourth PSA is required to be taken and be greater than the second measure. The subject must have a PSA ≥ 5 ng/ml in addition to increasing PSA to be eligible. No minimum PSA is required for subjects with measurable disease or non-PSA evaluable disease.
  • All subjects must have had a CT scan of the abdomen and pelvis within 84 days (12 weeks) prior to enrollment.
  • All subjects must also have had a bone scan within 112 days (16 weeks) prior to enrollment.
  • Subjects must have been surgically or medically castrated. If method of castration is LHRH agonists (leuprolide or goserelin), then the subject should be willing to continue the use of LHRH agonists. Castration using LHRH agonist should not be interrupted and subjects who have stopped treatment should be willing to restart.
  • If the subject has been treated with non-steroidal anti-androgens (flutamide, bicalutamide, nilutamide or ketoconazole), they must have been stopped at least 28 days prior to enrollment for flutamide or ketoconazole and at least 42 days prior to enrollment for bicalutamide or nilutamide and the subjects must have demonstrated progression.
  • Subjects may have received prior surgery. However, at least 21 days must have elapsed since completion of surgery and subject must have recovered from all side effects.
  • All subjects must have pre-study PSA within 28 days of enrollment.

Subjects must meet the following initial laboratory criteria:

  • granulocytes ≥ 1500/ul
  • platelet count ≥ 100,000/ul
  • hemoglobin ≥ 10 gms/dl
  • bilirubin ≤ 1.5 x ULN
  • AST ≤ 1.5 x ULN
  • Creatinine ≤ 1.5 x ULN
  • Testosterone < 50ng/ml for those who have not had bilateral orchiectomy
  • PSA ≥ 5ng/ml if no measurable disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00061035

Locations
United States, California
University of California, San Diego Cancer Center
San Diego, California, United States, 92093-0987
Sponsors and Collaborators
Cosmo Bioscience
Investigators
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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00061035     History of Changes
Obsolete Identifiers: NCT00066261
Other Study ID Numbers: TLI-CA-TRT-001
Study First Received: May 20, 2003
Last Updated: August 26, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Cosmo Bioscience:
Prostate Cancer; Immunotherapy

Additional relevant MeSH terms:
Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014