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A Phase I Gene Therapy Study of FP253/Fludarabine for Prostate Cancer

NCT00625430 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2011-07-11

No results posted yet for this study

Summary

The primary objective of this study is to determine the safety and tolerability of a gene-directed enzyme prodrug therapy for prostate cancer. FP253 contains an ovine atadenovirus that expresses the E. coli enzyme purine nucleoside phosphorylase (PNP) under the control of a prostate-directed promoter. PNP converts systemically administered fludarabine (the prodrug) into 2-fluoroadenine (the active agent) at the site where FP253 has been administered (the prostate). This localized conversion is expected to provide organ-targeted chemotherapy that should reduce the systemic side effects associated with classical chemotherapy and also reduce the risk of debilitating damage to tissues surrounding the prostate.

Conditions

Interventions

BIOLOGICAL

Gene Directed Enzyme Prodrug Therapy, FP253/Fludarabine

Subjects within a treatment group will be administered a single transrectal intraprostatic injection of FP253. Group A: 1 x 10Exp9 virus particles (VP); Group B: 3.2 x 10Exp9 VP; Group C: 1 x 10Exp10 VP; Group D: 3.2 x 10Exp10 VP; Group E: 1 x 10Exp11 VP; Group F: 3.2 x 10Exp 11 VP. If there are no dose-limiting toxicities, three additional patients may be treated at the highest dose. Twenty four hours following administration of the FP253, subjects will receive a first dose of fludarabine phosphate (20mg/m2 administered as an intravenous bolus). The first dose of fludarabine phosphate will be followed by 4 further doses at 24 hour intervals on treatment Days 3 to 6.

Sponsors & Collaborators

  • Biotech Equity Partners Pty Ltd

    lead INDUSTRY

Principal Investigators

  • David N Dalley, MB BS FRACP · St Vincent's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Australia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00625430 on ClinicalTrials.gov