NCT00061035

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2003

Completed
Last Updated

August 28, 2008

Status Verified

August 1, 2008

First QC Date

May 20, 2003

Last Update Submit

August 26, 2008

Conditions

Prostatic Neoplasms

Keywords

Prostate Cancer; Immunotherapy

Interventions

Transgenic Lymphocyte Immunization Vaccine (TLI)BIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Diego Cancer Center

San Diego, California, 92093-0987, United States

Location

Related 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. No abstract available.

    PMID: 12653092BACKGROUND

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Frederick E. Millard, M.D

    Associate Professor of Medicine at UCSD and Medical Director of the CTO of the UCSD Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 20, 2003

First Posted

May 22, 2003

Study Start

April 1, 2003

Last Updated

August 28, 2008

Record last verified: 2008-08

Locations

US(1)