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.

Détails

ID Serval
serval:BIB_F69BE76B77FF
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Institution
Titre
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.
Périodique
Oncoimmunology
Auteur⸱e⸱s
Rentsch C.A., Bosshard P., Mayor G., Rieken M., Püschel H., Wirth G., Cathomas R., Parzmair G.P., Grode L., Eisele B., Sharma H., Gupta M., Gairola S., Shaligram U., Goldenberger D., Spertini F., Audran R., Enoiu M., Berardi S., Hayoz S., Wicki A.
ISSN
2162-4011 (Print)
ISSN-L
2162-4011
Statut éditorial
Publié
Date de publication
2020
Peer-reviewed
Oui
Volume
9
Numéro
1
Pages
1748981
Langue
anglais
Notes
Publication types: Clinical Trial, Phase I ; Journal Article ; Research Support, Non-U.S. Gov't
Publication Status: epublish
Résumé
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.
Mots-clé
Administration, Intravesical, Aged, Aged, 80 and over, BCG Vaccine/administration & dosage, Humans, Male, Mycobacterium bovis/genetics, Mycobacterium bovis/immunology, Urinary Bladder Neoplasms/drug therapy, BCG-failure, GMO (genetically modified organism), NMIBC (Non-muscle-invasive bladder cancer), clinical trial, listeriolysin
Pubmed
Web of science
Open Access
Oui
Création de la notice
16/06/2020 16:10
Dernière modification de la notice
13/02/2024 8:23
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