Evaluation of Transgenic Lymphocyte Immunization Vaccine in Subjects With Prostate Adenocarcinoma

Prostatic Neoplasms Clinical Trial

Official title:

A Phase 1, Evaluation of Transgenic Lymphocyte Immunization Vaccine in Subjects With Prostate Adenocarcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00061035
• Other study ID #: TLI-CA-TRT-001
• Status: Completed
• Phase: Phase 1
• First received: May 20, 2003
• Last updated: August 26, 2008
• Start date: April 2003

Study information

• Verified date: August 2008
• Source: Cosmo Bioscience
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 patient's immune system react against telomerase, an enzyme expressed in prostate cancer cells.

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.

Other known NCT identifiers

• NCT00066261

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Prostatic Neoplasms

Intervention

Biological:
• Transgenic Lymphocyte Immunization Vaccine (TLI)

Locations

Country	Name	City	State
United States	University of California, San Diego Cancer Center	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Cosmo Bioscience

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

External Links

•   Click here for more information about this study: Clinical Trial Vaccine Therapy for Prostate Cancer