Status:
COMPLETED
A Clinical Trial of AdNRGM Plus CB1954 in Prostate Cancer
Lead Sponsor:
University of Birmingham
Collaborating Sponsors:
Janssen, LP
Department of Health, United Kingdom
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
This is an open label, non-randomised, phase I, sequential group trial which will explore the safety and tolerability of ascending doses of AdNRGM, in combination with CB1954. Five groups of 3 patient...
Detailed Description
Background and Rationale: Locally relapsed prostate cancer presents an attractive target for gene therapy because the tumour remains localised to the prostate or to the surrounding tissue for a long ...
Eligibility Criteria
Inclusion
- Patients who present with biopsy-proven local recurrence of prostate cancer following radical radiotherapy and a rising PSA with or without androgen suppression with antiandrogens or LHRH agonist/antagonist therapy or after bilateral orchidectomy. A rising PSA is defined as 2 increases over 3 or 4 readings over a minimum period of 6 weeks, with time-points separated by at least 2 weeks. If the patient is on antiandrogens or LHRH agonist/antagonist therapy, this therapy should be continued.
- Life expectancy greater than 3 months.
- Aged at least 18 years.
- Written informed consent.
- World Health Organisation (WHO) performance status of 0-1.
- PSA value ≥ 2 and ≤ 100 ng/ml at study entry.
- Adequate hepatic function (i.e. bilirubin, AST, ALT all \< 1.5 x upper limit of normal for Institution).
- Normal renal function (\<1.25 x upper normal limit for the Institution).
- Adequate haematological function (i.e. haemoglobin \> 10g/dl, WCC \> 3x109/l, platelets \> 150x10\^9/l) and normal clotting (INR and APTT \<1.2).
- Patients must agree not to father a child within 12 months following AdNRGM administration, and must use at least two methods of contraception, one of which is barrier, starting from the time of AdNRGM administration for at least 12 months.
- No known immuno-incompetence.
Exclusion
- Patients with a prostate or abnormal focus which is deemed clinically unsuitable for trans-perineal template-guided injection.
- Patients who have previously been treated with prostate brachytherapy.
- Patients who have previously been treated with AdNRGM and CB1954; or who have been administered any other human adenovirus type 5 vector within the last 5 years.
- Patients who have received chemotherapy, radiotherapy or immunotherapy within 28 days of study entry.
- Acute active infection (viral, bacterial, or fungal) which requires specific therapy.
- Chronic hepatitis B or C infection, HIV positive patients. (Patients will be tested for HBV/HCV, but not HIV).
- Concurrent severe medical illnesses incompatible with the treatment including psychiatric pathology likely to affect protocol compliance.
- Tumours of other organs or tissues of high malignant potential still active or treated radically less than 3 years before (except that successfully treated, non-metastatic skin cancers or non-muscle invasive bladder cancers are not an exclusion criterion).
- Concurrent corticosteroids, or any medication known to have significant immunosuppressive action.
- Patients unable to travel for regular hospital assessments.
- Evidence of adenovirus infection and/or shedding at baseline.
- Clinical judgement by the Investigator that the patient should not participate in the study.
Key Trial Info
Start Date :
March 19 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2021
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04374240
Start Date
March 19 2013
End Date
August 1 2021
Last Update
November 3 2021
Active Locations (1)
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1
Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust
Birmingham, West Midlands, United Kingdom, B15 2GW