The proposed dose levels for AdNRGM are 10^10, 3x10^10, 10^11, 3x10^11, 10^12 vp while the prodrug CB1954 will be given at a standard dose of 24 mg/m^2

Prostate Cancer

AdNRGM is an E1-E3 deleted, replication deficient type 5 adenovirus which contains the E. coli NTR gene regulated by the CMV promoter, an internal ribosomal entry site (IRES) and the human GMCSF gene.
CB1954 [5-(aziridin-1-yl)-2,4-dinitrobenzamide]

AdNRGM

University Of Birmingham

A Clinical Trial of AdNRGM Plus CB1954 in Prostate Cancer

Phase I Trial of Replicative Defective Type 5 Adenovirus Vector Expressing Nitroreductase & GMCSF Given Via Trans-perineal Template-guided Intra-prostatic Injection Followed by iv CB1954 in Locally Relapsed Prostate Cancer Patients

Safety will be assessed in terms of local effects on the tumour, the prostate gland and the lower urinary tract as well as in terms of systemic effects. The data will be summarised descriptively.
Adverse events and side effects will be determined as changes of the relevant clinical parameters as well as changes of haematological and clinical biochemistry data.

Changes in the level (ng/ml) of the serum PSA will be measured in to provide an indication of changes in tumour burden, growth rate and possible anti-tumour activity of the treatment.

Treatment-induced immune responses will be assessed by measurement of T cell responses to prostate cancer antigens in blood samples collected at baseline and at intervals (2, 3, 4, and 8 weeks) following treatment.

Evidence of tumour destruction and immune infiltration will be assessed by looking at patterns of tissue damage, residual tumour tissue and immune cell infiltrates detected by immunohistochemistry in post treatment prostate biopsies .

diaphorase/fatigue

A Clinical Trial of AdNRGM Plus CB1954 in Prostate Cancer

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