Status:
UNKNOWN
A Phase I Gene Therapy Study of FP253/Fludarabine for Prostate Cancer
Lead Sponsor:
Biotech Equity Partners Pty Ltd
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief 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...
Detailed Description
OBJECTIVES: The primary objective of this study is to determine the safety and tolerability of FP253 for prostate cancer. FP253 contains an ovine atadenovirus that expresses the E. coli enzyme purine ...
Eligibility Criteria
Inclusion
- Inclusion Criteria (Prostate Cancer Categorization):
- Subjects will have adenocarcinoma of the prostate which is progressive despite androgen deprivation therapy.
- Subjects MUST fulfil each of the following criteria for inclusion in this study:
- Biopsy of the tumour must have been performed and histological status of adenocarcinoma of the prostate documented. The diagnostic prostatic biopsy will have taken place at least 4 weeks prior to the planned day 1.
- Subjects will have their prostate in situ.
- Biochemical evidence of prostate cancer recurrence; defined as a rise over 3 successive PSA measurements spanning a minimum of 3 months (no lower limit of PSA exclusion).
- Subjects will have been treated with androgen deprivation therapy and will remain on hormone therapy for the duration of the study (LHRH agonists with or without antiandrogens, or bilateral orchidectomy).
- The Investigator should be able to localise the tumour either by digital rectal examination (DRE) (i.e. tumour palpable); or the tumour should be visible on transrectal ultrasound (TRUS). Localization of tumour will be documented and should be adequate to allow the Investigators to inject it. Repeated TRUS will be at the discretion of the Investigator General.
- Inclusion Criteria (General):
- Subjects MUST fulfil each of the following criteria for inclusion into this study:
- Be male and be 18 years of age or greater.
- Have voluntarily given written informed consent to participate in this study.
- Have an ECOG performance status of 0, 1 or 2.
- Have agreed to remain confined to the clinical testing facility for the first 3 days (2 nights) of the study.
- Have adequate baseline organ function.
- Have an ECG which is normal, or, if there is any abnormality, it must be considered to be clinically insignificant in the context of the trial.
- Exclusion Criteria (Prostate Cancer Categorization):
- Subjects with any of the following criteria will NOT be eligible for participation in this study:
- Subjects who have had prior radical prostatectomy.
- Subjects who are expected to die of prostate cancer within 3 months.
- Exclusion Criteria (General):
- Subjects with any of the following criteria will NOT be eligible for participation in this study:
- Hypersensitivity to ciprofloxacin, fludarabine, pegfilgrastim or similar compounds.
- Contraindications to fludarabine: subjects with decompensated haemolytic anaemia.
- Contraindications to pegfilgrastim: known hypersensitivity to E. coli derived products.
- Other associated or concomitant medical conditions that would interfere with the conduct of the study in the opinion of the treating physician.
- Have used an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
- Are immunocompromised or have used immunomodulatory agents/therapy within the 6 months preceding the initial treatment.
- Subjects who, at the sole discretion of the Investigator, are judged to be unsuitable for participation in the study.
Exclusion
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00625430
Start Date
March 1 2008
End Date
December 1 2012
Last Update
July 11 2011
Active Locations (1)
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1
St Vincent's Hospital, Sydney
Darlinghurst, New South Wales, Australia, 2010