2,121
Views
19
CrossRef citations to date
0
Altmetric
Brief Report

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

, ORCID Icon, , , , , , , , , , , ORCID Icon, , , , ORCID Icon, , , ORCID Icon & show all
Article: 1748981 | Received 09 Jul 2019, Accepted 18 Jan 2020, Published online: 21 Apr 2020

References

  • Babjuk M, Burger M, Compérat E, Gontero P, Mostafid AH, Palou J, van Rhijn BWG, Rouprêt M, Shariat SF, Sylvester R, et al. European association of urology guidelines 2018 Edition. Arnhem (The Netherlands): European Association of Urology Guidelines Office; 2018
  • Sylvester RJ, van der MA, Lamm DL. Intravesical bacillus Calmette-Guerin reduces the risk of progression in patients with superficial bladder cancer: a meta-analysis of the published results of randomized clinical trials. J Urol. 2002;168(5):1964–8. doi:10.1016/S0022-5347(05)64273-5.
  • Herr HW, Schwalb DM, Zhang ZF, Sogani PC, Fair WR, Whitmore WF Jr, Oettgen HF. Intravesical bacillus Calmette-Guerin therapy prevents tumor progression and death from superficial bladder cancer: ten-year follow-up of a prospective randomized trial. J Clin Oncol. 1995;13(6):1404–1408. doi:10.1200/JCO.1995.13.6.1404.
  • Malmstrom PU, Sylvester RJ, Crawford DE, Friedrich M, Krege S, Rintala E, Solsona E, Di Stasi SM, Witjes JA. An individual patient data meta-analysis of the long-term outcome of randomised studies comparing intravesical mitomycin C versus bacillus Calmette-Guerin for non-muscle-invasive bladder cancer. Eur Urol. 2009;56(2):247–256. doi:10.1016/j.eururo.2009.04.038.
  • Biot C, Rentsch CA, Gsponer JR, Birkhauser FD, Jusforgues-Saklani H, Lemaitre F, Auriau C, Bachmann A, Bousso P, Demangel C, et al. Preexisting BCG-specific T cells improve intravesical immunotherapy for bladder cancer. Sci Transl Med. 2012;4(137):137ra72. doi:10.1126/scitranslmed.3003586.
  • Pettenati C, Ingersoll MA. Mechanisms of BCG immunotherapy and its outlook for bladder cancer. Nat Rev Urol. 2018;15(10):615–625. doi:10.1038/s41585-018-0055-4.
  • Di Lorenzo G, Perdona S, Damiano R, Faiella A, Cantiello F, Pignata S, Ascierto P, Simeone E, De Sio M, Autorino R, et al. Gemcitabine versus bacille Calmette-Guérin after initial bacille Calmette-Guérin failure in non-muscle-invasive bladder cancer. Cancer. 2010;116(8):1893–1900. doi:10.1002/cncr.24914.
  • Dietrich G, Viret J-F, Hess J. Novel vaccination strategies based on recombinant Mycobacterium bovis BCG. Int J Med Microbiol. 2003;292(7–8):441–451. doi:10.1078/1438-4221-00227.
  • Nieuwenhuizen NE, Kulkarni PS, Shaligram U, Cotton MF, Rentsch CA, Eisele B, Grode L, Kaufmann SHE. The recombinant Bacille Calmette-Guerin vaccine VPM1002: ready for clinical efficacy testing. Front Immunol. 2017;8:1147. doi:10.3389/fimmu.2017.01147.
  • Andersen CS, Dietrich J, Agger EM, Lycke NY, Lovgren K, Andersen P. The combined CTA1-DD/ISCOMs vector is an effective intranasal adjuvant for boosting prior Mycobacterium bovis BCG immunity to Mycobacterium tuberculosis. Infect Immun. 2007;75(1):408–416. doi:10.1128/IAI.01290-06.
  • Grode L, Seiler P, Baumann S, Hess J, Brinkmann V, Nasser Eddine A, Mann P, Goosmann C, Bandermann S, Smith D, et al. Increased vaccine efficacy against tuberculosis of recombinant Mycobacterium bovis bacille Calmette-Guerin mutants that secrete listeriolysin. J Clin Invest. 2005;115(9):2472–2479. doi:10.1172/JCI24617.
  • Kaufmann SH, Cole ST, Mizrahi V, Rubin E, Nathan C. Mycobacterium tuberculosis and the host response. J Exp Med. 2005;201(11):1693–1697. doi:10.1084/jem.20050842.
  • Grode L, Ganoza CA, Brohm C, Weiner J 3rd, Eisele B, Kaufmann SH. Safety and immunogenicity of the recombinant BCG vaccine VPM1002 in a phase 1 open-label randomized clinical trial. Vaccine. 2013;31(9):1340–1348. doi:10.1016/j.vaccine.2012.12.053.
  • World Medical A. World medical association declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013;310(20):2191–2194. doi:10.1001/jama.2013.281053.
  • International Conference on Harmonization (ICH) (1996) E 6 guideline for good clinical practice. [accessed 10June 1996]. https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf.
  • Hinic V, Feuz K, Turan S, Berini A, Frei R, Pfeifer K, Goldenberger D. Clinical evaluation of the Abbott RealTime MTB assay for direct detection of Mycobacterium tuberculosis-complex from respiratory and non-respiratory samples. Tuberculosis (Edinb). 2017;104:65–69. doi:10.1016/j.tube.2017.03.002.
  • Bisiaux A, Thiounn N, Timsit M-O, Eladaoui A, Chang -H-H, Mapes J, Mogenet A, Bresson J-L, Prié D, Béchet S, et al. Molecular analyte profiling of the early events and tissue conditioning following intravesical bacillus calmette-guerin therapy in patients with superficial bladder cancer. J Urol. 2009;181(4):1571–1580. doi:10.1016/j.juro.2008.11.124.
  • Durek C, Richter E, Basteck A, Rusch-Gerdes S, Gerdes J, Jocham D, Bohle A. The fate of bacillus Calmette-Guerin after intravesical instillation. J Urol. 2001;165(5):1765–1768. doi:10.1016/S0022-5347(05)66410-5.
  • Marsh HP, Haldar NA, Bunce M, Marshall SE, le Monier K, Winsey SL, Christodoulos K, Cranston D, Welsh KI, Harris AL, et al. Polymorphisms in tumour necrosis factor (TNF) are associated with risk of bladder cancer and grade of tumour at presentation. Br J Cancer. 2003;89(6):1096–1101. doi:10.1038/sj.bjc.6601165.
  • Jinesh GG, Chunduru S, Kamat AM. Smac mimetic enables the anticancer action of BCG-stimulated neutrophils through TNF-alpha but not through TRAIL and FasL. J Leukoc Biol. 2012;92(1):233–244. doi:10.1189/jlb.1211623.
  • Simons MP, Nauseef WM, Griffith TS. Neutrophils and TRAIL: insights into BCG immunotherapy for bladder cancer. Immunol Res. 2007;39(1–3):79–93. doi:10.1007/s12026-007-0084-1.
  • Shintani Y, Sawada Y, Inagaki T, Kohjimoto Y, Uekado Y, Shinka T. Intravesical instillation therapy with bacillus Calmette-Guerin for superficial bladder cancer: study of the mechanism of bacillus Calmette-Guerin immunotherapy. Int J Urol. 2007;14(2):140–146. doi:10.1111/j.1442-2042.2007.01696.x.
  • Elsasser J, Janssen MW, Becker F, Suttmann H, Schmitt K, Sester U, Stöckle M, Sester M. Antigen-specific CD4 T cells are induced after intravesical BCG-instillation therapy in patients with bladder cancer and show similar cytokine profiles as in active tuberculosis. PLoS One. 2013;8(9):e69892. doi:10.1371/journal.pone.0069892.