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 .

University of Birmingham

A percutaneous (utlrasound-guided) radiofrequency ablation (RFA) of the tumor will be performed by the radiologist under general anesthesia. Immediately after, excision of the tumor with appropriate margin will be accomplished.

Normal excision of the tumor according to the protocol

Breast Cancer

After tumor ablation and excision of the tumor, the pathologist performed a macroscopic study of the specimen,measuring the distance between the tumor and the margin in order to indicate if extensions are mandatory. Secondly and delayed, margins will be evaluated microscopically by H&E stain. Furthermore, the tumoral viability in the ablation zone will be evaluated by NADH-diaphorase, COX and tunnel.

Radiofrequency ablation

Hospital Universitario Bellvitge

Radiofrequency Ablation in Breast Cancer

Impact of Radiofrequency Ablation on Surgical Margins in Early Stage of Malignant Breast Tumors

The pathologist performed a macroscopic study of the specimen, measuring the distance between the tumor and the margin in order to indicate if extensions are mandatory.

Adverse effects and cosmetic result will be evaluated 15 days after the procedure

Tumoral viability in the ablation zone will be evaluated by NADH-diaphorase, COX and tunel

Amparo Garcia-Tejedor

MD PhD

Hospital Universitari de Bellvitge

Unspecified Adult Solid Tumor, Protocol Specific

Patients receive mitomycin IV over 20 to 30 minutes on day 1 and irinotecan IV over 90 minutes on days 2, 8, 15, and 22, followed by 2 weeks of rest beginning on day 29. Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3 to 6 patients each receive escalating doses of mitomycin and irinotecan until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity. Patients are followed for 1 month.

diaphorase/neoplasms

A Clinical Trial of AdNRGM Plus CB1954 in Prostate Cancer

Radiofrequency Ablation in Breast Cancer

Irinotecan Plus Mitomycin in Treating Patients With Advanced Solid Tumors

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