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

May 20, 2003
August 26, 2008
April 2003
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Complete list of historical versions of study NCT00061035 on ClinicalTrials.gov Archive Site
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Evaluation of Transgenic Lymphocyte Immunization Vaccine in Subjects With Prostate Adenocarcinoma
A Phase 1, Evaluation of Transgenic Lymphocyte Immunization Vaccine in Subjects With Prostate Adenocarcinoma

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostatic Neoplasms
Biological: Transgenic Lymphocyte Immunization Vaccine (TLI)
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Zanetti M. Protocol #0207-545: a phase I/II, escalating dose, open-label evaluation of safety, feasibility, and tolerability of transgenic lymphocyte immunization (TLI) vaccine subjects with histologically proven prostate adenocarcinoma. Hum Gene Ther. 2003 Feb 10;14(3):301-2. No abstract available.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
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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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00061035
TLI-CA-TRT-001
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Cosmo Bioscience
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Principal Investigator: Frederick E. Millard, M.D Associate Professor of Medicine at UCSD and Medical Director of the CTO of the UCSD Cancer Center
Cosmo Bioscience
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP