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Phase 1 trial of vocimagene amiretrorepvec and 5-fluorocytosine for recurrent high-grade glioma.
Cloughesy, Timothy F; Landolfi, Joseph; Hogan, Daniel J; Bloomfield, Stephen; Carter, Bob; Chen, Clark C; Elder, J Bradley; Kalkanis, Steven N; Kesari, Santosh; Lai, Albert; Lee, Ian Y; Liau, Linda M; Mikkelsen, Tom; Nghiemphu, Phioanh Leia; Piccioni, David; Walbert, Tobias; Chu, Alice; Das, Asha; Diago, Oscar R; Gammon, Dawn; Gruber, Harry E; Hanna, Michelle; Jolly, Douglas J; Kasahara, Noriyuki; McCarthy, David; Mitchell, Leah; Ostertag, Derek; Robbins, Joan M; Rodriguez-Aguirre, Maria; Vogelbaum, Michael A.
Afiliación
  • Cloughesy TF; Department of Neuro-Oncology and Department of Neurosurgery, 710 Westwood Plaza, University of California, Los Angeles, Los Angeles, CA 90095, USA.
  • Landolfi J; New Jersey Neuroscience Institute, John F. Kennedy Medical Center, 65 James Street, Edison, NJ 08820, USA.
  • Hogan DJ; Tocagen Inc., 3030 Bunker Hill Street, San Diego, CA 92109, USA.
  • Bloomfield S; New Jersey Neuroscience Institute, John F. Kennedy Medical Center, 65 James Street, Edison, NJ 08820, USA.
  • Carter B; Moores Cancer Center, Department of Neurosciences, University of California, San Diego, 3855 Health Sciences Drive, La Jolla, CA 92093, USA.
  • Chen CC; Moores Cancer Center, Department of Neurosciences, University of California, San Diego, 3855 Health Sciences Drive, La Jolla, CA 92093, USA.
  • Elder JB; Ohio State University Wexner Medical Center, 410 West 10th Avenue, Columbus, OH 43210, USA.
  • Kalkanis SN; Henry Ford Hospital, 2799 West Grand Boulevard, Detroit, MI 48202, USA.
  • Kesari S; Moores Cancer Center, Department of Neurosciences, University of California, San Diego, 3855 Health Sciences Drive, La Jolla, CA 92093, USA.
  • Lai A; Department of Neuro-Oncology and Department of Neurosurgery, 710 Westwood Plaza, University of California, Los Angeles, Los Angeles, CA 90095, USA.
  • Lee IY; Henry Ford Hospital, 2799 West Grand Boulevard, Detroit, MI 48202, USA.
  • Liau LM; Department of Neuro-Oncology and Department of Neurosurgery, 710 Westwood Plaza, University of California, Los Angeles, Los Angeles, CA 90095, USA.
  • Mikkelsen T; Henry Ford Hospital, 2799 West Grand Boulevard, Detroit, MI 48202, USA.
  • Nghiemphu PL; Department of Neuro-Oncology and Department of Neurosurgery, 710 Westwood Plaza, University of California, Los Angeles, Los Angeles, CA 90095, USA.
  • Piccioni D; Moores Cancer Center, Department of Neurosciences, University of California, San Diego, 3855 Health Sciences Drive, La Jolla, CA 92093, USA.
  • Walbert T; Henry Ford Hospital, 2799 West Grand Boulevard, Detroit, MI 48202, USA.
  • Chu A; Tocagen Inc., 3030 Bunker Hill Street, San Diego, CA 92109, USA.
  • Das A; Tocagen Inc., 3030 Bunker Hill Street, San Diego, CA 92109, USA.
  • Diago OR; Tocagen Inc., 3030 Bunker Hill Street, San Diego, CA 92109, USA.
  • Gammon D; Tocagen Inc., 3030 Bunker Hill Street, San Diego, CA 92109, USA.
  • Gruber HE; Tocagen Inc., 3030 Bunker Hill Street, San Diego, CA 92109, USA.
  • Hanna M; Ribomed Biotechnologies Inc., 3030 Bunker Hill Street, San Diego, CA 92109, USA. University of Arizona Cancer Center, 1515 North Campbell Avenue, Tucson, AZ 85724, USA.
  • Jolly DJ; Tocagen Inc., 3030 Bunker Hill Street, San Diego, CA 92109, USA.
  • Kasahara N; Department of Cell Biology and Sylvester Comprehensive Cancer Center, Miller School of Medicine, University of Miami, Miami, FL 33136, USA.
  • McCarthy D; Ribomed Biotechnologies Inc., 3030 Bunker Hill Street, San Diego, CA 92109, USA.
  • Mitchell L; Tocagen Inc., 3030 Bunker Hill Street, San Diego, CA 92109, USA.
  • Ostertag D; Tocagen Inc., 3030 Bunker Hill Street, San Diego, CA 92109, USA.
  • Robbins JM; Tocagen Inc., 3030 Bunker Hill Street, San Diego, CA 92109, USA.
  • Rodriguez-Aguirre M; Tocagen Inc., 3030 Bunker Hill Street, San Diego, CA 92109, USA.
  • Vogelbaum MA; Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH 44195, USA. vogelbm@ccf.org.
Sci Transl Med ; 8(341): 341ra75, 2016 06 01.
Article en En | MEDLINE | ID: mdl-27252174
Toca 511 (vocimagene amiretrorepvec) is an investigational nonlytic, retroviral replicating vector (RRV) that delivers a yeast cytosine deaminase, which converts subsequently administered courses of the investigational prodrug Toca FC (extended-release 5-fluorocytosine) into the antimetabolite 5-fluorouracil. Forty-five subjects with recurrent or progressive high-grade glioma were treated. The end points of this phase 1, open-label, ascending dose, multicenter trial included safety, efficacy, and molecular profiling; survival was compared to a matching subgroup from an external control. Overall survival for recurrent high-grade glioma was 13.6 months (95% confidence interval, 10.8 to 20.0) and was statistically improved relative to an external control (hazard ratio, 0.45; P = 0.003). Tumor samples from subjects surviving more than 52 weeks after Toca 511 delivery disproportionately displayed a survival-related mRNA expression signature, identifying a potential molecular signature that may correlate with treatment-related survival rather than being prognostic. Toca 511 and Toca FC show excellent tolerability, with RRV persisting in the tumor and RRV control systemically. The favorable assessment of Toca 511 and Toca FC supports confirmation in a randomized phase 2/3 trial (NCT02414165).
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Retroviridae / Vectores Genéticos / Glioma Tipo de estudio: Clinical_trials Idioma: En Revista: Sci Transl Med Asunto de la revista: CIENCIA / MEDICINA Año: 2016 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Retroviridae / Vectores Genéticos / Glioma Tipo de estudio: Clinical_trials Idioma: En Revista: Sci Transl Med Asunto de la revista: CIENCIA / MEDICINA Año: 2016 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos