UNIGE document Scientific Article
previous document  unige:136297  next document
add to browser collection
Title

Results of the phase I open label clinical trial SAKK 06/14 assessing safety of intravesical instillation of VPM1002BC, a recombinant mycobacterium Bacillus Calmette Guérin (BCG), in Patients With Non-Muscle Invasive Bladder Cancer and Previous Failure of Conventional BCG Therapy

Authors
Rentsch, Cyrill A
Bosshard, Piet
Rieken, Malte
Püschel, Heike
Cathomas, Richard
Parzmair, Gerald P
show hidden authors show all authors [1 - 21]
Published in OncoImmunology. 2020, vol. 9, no. 1, p. 1748981
Abstract Background: VPM1002BC is a modified mycobacterium Bacillus Calmette Guérin (BCG) for the treatment of non-muscle invasive bladder cancer (NMIBC). The genetic modifications are expected to result in better immunogenicity and less side effects. We report on patient safety and immunology of the first intravesical application of VPM1002BC in human. Methods: Six patients with BCG failure received a treatment of 6 weekly instillations with VPM1002BC. Patients were monitored for adverse events (AE), excretion of VPM1002BC and cytokines, respectively. Results: No DLT (dose limiting toxicity) occurred during the DLT-period. No grade ≥3 AEs occurred. Excretion of VPM1002BC in the urine was limited to less than 24 hours. Plasma levels of TNFα significantly increased after treatment and blood-derived CD4+ T cells stimulated with PPD demonstrated significantly increased intracellular GM-CSF and IFN expression. Conclusion: The intravesical application of VPM1002BC is safe and well tolerated by patients and results in a potential Th1 weighted immune response.
Keywords BCG-failureGMO (genetically modified organism)NMIBC (Non-muscle-invasive bladder cancer)Clinical trialListeriolysin
Identifiers
PMID: 32363120
Full text
Structures
Research group Groupe Iselin Christophe (urologie) (106)
Project Swiss Cancer Research Foundation (SCS); Swiss Cancer League (SCL)
Citation
(ISO format)
RENTSCH, Cyrill A et al. Results of the phase I open label clinical trial SAKK 06/14 assessing safety of intravesical instillation of VPM1002BC, a recombinant mycobacterium Bacillus Calmette Guérin (BCG), in Patients With Non-Muscle Invasive Bladder Cancer and Previous Failure of Conventional BCG Therapy. In: OncoImmunology, 2020, vol. 9, n° 1, p. 1748981. doi: 10.1080/2162402X.2020.1748981 https://archive-ouverte.unige.ch/unige:136297

40 hits

11 downloads

Update

Deposited on : 2020-06-01

Export document
Format :
Citation style :