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| [ Print-friendly version ] |
| AdUP: AdNRGM; VDEPT + GMCSF in locally recurrent prostate cancer |
| ISRCTN | ISRCTN06254734 |
| DOI | 10.1186/ISRCTN06254734 |
| ClinicalTrials.gov identifier | |
| EudraCT number | 2007-700341-13 |
| Public title | AdUP: AdNRGM; VDEPT + GMCSF in locally recurrent prostate cancer |
| Scientific title | AdUP: A Phase I Clinical Trial of a replication defective type 5 adenovirus vector expressing nitroreductase and GMCSF (AdNRGM) given via trans-perineal, template-guided, intra-prostatic injection, followed by intravenous CB1954, in patients with locally relapsed hormone-refractory Prostate Cancer |
| Acronym | AdUP |
| Serial number at source | 13599 |
| Study hypothesis |
The main purpose of this trial is to determine safety and tolerability of a gene therapy strategy for the treatment of locally relapsed prostate cancer. The gene therapy is based on the intraprostatic injection of a viral vector (AdNRGM) carrying a gene called GMCSF which is able to induce a strong immune response against the prostate cancer, and a gene called NTR which is able to convert an inactive compound called CB1954 (prodrug) to a powerful anti-cancer drug. To ensure coverage of the whole prostate the vector will be administered by multiple stereotactically-guided intraprostatic injections. 48 hours after the injection of the viral vector, the prodrug CB1954 will be administered intravenously. It is expected that the combination of the immune response induced by the GMCSF and the activation of the prodrug C1954 operated by NTR within the tumour tissue will result in the death of a significant number of prostate cancer cells.
More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=13599 |
| Lay summary | Lay summary under review with external organisation |
| Ethics approval | Oxford A, 07/12/2012, ref: 12_SC_0660 |
| Study design | Non-randomised interventional; Design type: Treatment |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Prostate Cancer |
| Participants - inclusion criteria |
1. Patients who present with biopsy proven local recurrence of prostate cancer following radical radiotherapy and a rising PSA while on androgen suppression with LHRH agonist therapy or after bilateral orchidectomy. A rising PSA is defined as 3 consecutive increases (measured by the same laboratory) over a minimum period of 6 weeks, with timepoints separated by at least 15 days. If the patient is on LHRH agonist therapy, this therapy should be continued.
2. Life expectancy greater than 3 months 3. Aged at least 18 years 4. Written informed consent 5. WHO performance status of 0-1 (Appendix 2) 6. PSA value = 4 and = 25 ng/ml at study entry 7. Adequate hepatic function (i.e. bilirubin, AST, ALT all < 1.5 x upper limit of normal for Institution) 8. Normal renal function (<1.25 x upper normal limit for the Institution) 9. Adequate haematological function (i.e. haemoglobin > 10g/dl, WCC > 3x109/l, platelets > 150x109/l) and normal clotting (INR and APTT <1.2) 10. Patients must agree not to father a child within 12 months following AdNRGM administration, and must practice a barrier method of contraception starting from the time of AdNRGM administration for at least 12 months 11. No known immunoincompetence |
| Participants - exclusion criteria |
1. Patients with a prostate or tumour which is deemed clinically unsuitable for transperineal templateguided injection
2. Patients who have previously been treated with prostate brachytherapy 3. Patients who have received chemotherapy, radiotherapy or immunotherapy within 28 days of study entry 4. Acute active infection (viral, bacterial, or fungal) which requires specific therapy 5. Chronic hepatitis B or C infection, HIV positive patients. (Patients will be tested for HBV/HCV, but not HIV) 6. Concurrent severe medical illnesses incompatible with the treatment including psychiatric pathology likely to affect protocol compliance 7. Tumours of other organs or tissues still active or treated radically less that 3 years before (except that successfully treated, nonmetastatic skin cancers are not an exclusion criterion) 8. Concurrent corticosteroids, or any medication known to have significant immunosuppressive action 9. Patients unable to travel for regular hospital assessments 10. Evidence of adenovirus infection and/or shedding at prescreening |
| Anticipated start date | 15/03/2013 |
| Anticipated end date | 31/01/2014 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | UK Sample Size: 15 |
| Interventions |
AdNRGM Administration, Template-guided prostate brachytherapy
CB1954 Infusion, Infusion of 24 mg/m2 |
| Primary outcome measure(s) | Toxicity; Timepoint(s): Up to end of Month 11 visit |
| Secondary outcome measure(s) | PSA Level and Kinetics; Timepoint(s): Up to end of Month 11 |
| Sources of funding |
1. Cancer Research UK (UK); Grant Codes: C198/A9699
2. Medical Research Council (MRC) (UK) |
| Trial website | |
| Publications | |
| Contact name | Dr Laura Crack |
| Address |
Cancer Research UK Clinical Trials Unit
Institute for Cancer Studies Edgbaston |
| City/town | Birmingham |
| Zip/Postcode | B15 2TT |
| Country | United Kingdom |
| l.r.crack@bham.ac.uk | |
| Sponsor | University of Birmingham (UK) |
| Address | Edgbaston |
| City/town | Birmingham |
| Zip/Postcode | B15 2TT |
| Country | United Kingdom |
| Sponsor website: | http://www.birmingham.ac.uk |
| Date applied | 28/02/2013 |
| Last edited | 08/03/2013 |
| Date ISRCTN assigned | 28/02/2013 |
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