A Phase 1, evaluation of Transgenic Lymphocyte Immunization vaccine in subjects with prostate adenocarcinoma.
This study is currently recruiting patients.
Sponsored by: |
Cosmo Bioscience |
Information provided by: |
Cosmo Bioscience |
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
|
Treatment or Intervention |
Phase |
Prostatic Neoplasms
|
Vaccine: Transgenic Lymphocyte Immunization Vaccine (TLI)
|
Phase I
|
MedlinePlus related topics: Prostate Cancer
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study
Further Study Details:
Expected Total Enrollment:
18
Study start: 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 above,
Genders Eligible for Study:
Male
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
Location
and Contact
Information
California University of California, San Diego Cancer Center, San Diego,
California,
92093-0987,
United States; Recruiting
Study chairs or principal investigators
Frederick E. Millard, M.D, Principal Investigator, Associate Professor of Medicine at UCSD and Medical Director of the CTO of the UCSD Cancer Center
More Information
Click here for more information about this study: Clinical Trial Vaccine Therapy for Prostate Cancer
Publications
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.
Study ID Numbers:
TLI-CA-TRT-001
Record last reviewed:
May 2003
Record first received:
May 20, 2003
ClinicalTrials.gov Identifier:
NCT00061035Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10