A Clinical Trial of AdNRGM Plus CB1954 in Prostate Cancer (AdUP)
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|ClinicalTrials.gov Identifier: NCT04374240|
Recruitment Status : Active, not recruiting
First Posted : May 5, 2020
Last Update Posted : May 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Genetic: AdNRGM||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||AdNRGM plus CB1954|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||March 19, 2013|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||August 2020|
Experimental: AdNRGM followed on day 2 by CB1954
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
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.
Other Name: CB1954
- Safety and tolerability of escalating doses of AdNRGM, followed by iv CB1954 determined by assessing local effects on tumour etc. and number of participants with treatment related adverse events by CTCAE v4.0 [ Time Frame: 12 months ]
- 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.
- Measuring PSA levels following treatment with AdNRGM and CB1954 [ Time Frame: 12 months ]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.
- To assess the evidence for local tumour destruction, and immune infiltration, in tumour biopsies taken after the treatment [ Time Frame: 8 weeks post 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.
- To investigate changes in cellular immune response to prostate cancer antigens following treatment with AdNRGM and CB1954 [ Time Frame: 12 months ]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 .
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04374240
|University Of Birmingham|
|Birmingham, West Midlands, United Kingdom, B15 2TT|
|Principal Investigator:||Prashant Patel, FRCS Ed||University of Birmingham|