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Phase I Trial of Intravenous Oncolytic Vaccinia Virus (GL-ONC1) with Cisplatin and Radiotherapy in Patients with Locoregionally Advanced Head and Neck Carcinoma.
Mell, Loren K; Brumund, Kevin T; Daniels, Gregory A; Advani, Sunil J; Zakeri, Kaveh; Wright, Mary E; Onyeama, Sara-Jane; Weisman, Robert A; Sanghvi, Parag R; Martin, Peter J; Szalay, Aladar A.
Afiliación
  • Mell LK; Center for Translational Radiation Medicine and Imaging, Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California. lmell@ucsd.edu.
  • Brumund KT; Department of Surgery, Division of Otolaryngology-Head and Neck Surgery, University of California San Diego, La Jolla, California.
  • Daniels GA; Center for Personalized Cancer Therapy, and Division of Hematology and Oncology, UCSD Moores Cancer Center, La Jolla, California.
  • Advani SJ; Center for Translational Radiation Medicine and Imaging, Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California.
  • Zakeri K; Center for Translational Radiation Medicine and Imaging, Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California.
  • Wright ME; Center for Translational Radiation Medicine and Imaging, Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California.
  • Onyeama SJ; Center for Translational Radiation Medicine and Imaging, Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California.
  • Weisman RA; Department of Surgery, Division of Otolaryngology-Head and Neck Surgery, University of California San Diego, La Jolla, California.
  • Sanghvi PR; Center for Translational Radiation Medicine and Imaging, Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California.
  • Martin PJ; Department of Otolaryngology, Kaiser Permanente, San Diego, California.
  • Szalay AA; Center for Translational Radiation Medicine and Imaging, Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California.
Clin Cancer Res ; 23(19): 5696-5702, 2017 Oct 01.
Article en En | MEDLINE | ID: mdl-28679776
Purpose: Preclinical models have shown that the effectiveness of GL-ONC1, a modified oncolytic vaccinia virus, is enhanced by radiation and chemotherapy. The purpose of this study was to determine the safety of GL-ONC1 when delivered intravenously with chemoradiotherapy to patients with primary, nonmetastatic head and neck cancer.Experimental Design: Patients with locoregionally advanced unresected, nonmetastatic carcinoma of the head/neck, excluding stage III-IVA p16-positive oropharyngeal cancers, were treated with escalating doses and cycles of intravenous GL-ONC1, along with radiotherapy and chemotherapy. The primary aims were to define the MTD and dose-limiting toxicities, and to recommend a dose for phase II trials.Results: Between May 2012 and December 2014, 19 patients were enrolled. The most frequent adverse reactions included grade 1-2 rigors, fever, fatigue, and rash. Grade 3 adverse reactions included hypotension, mucositis, nausea, and vomiting. In 2 patients, the rash was confirmed as viral in origin by fluorescence imaging and viral plaque assay. In 4 patients, viral presence in tumor was confirmed on midtreatment biopsy by quantitative PCR. In 1 patient, live virus was confirmed in a tongue tumor 7 days after receiving the first dose of virus. The MTD was not reached. With median follow-up of 30 months, 1-year (2-year) progression-free survival and overall survival were 74.4% (64.1%) and 84.6% (69.2%), respectively.Conclusions: Delivery of GL-ONC1 is safe and feasible in patients with locoregionally advanced head/neck cancer undergoing standard chemoradiotherapy. A phase II study is warranted to further investigate this novel treatment strategy. Clin Cancer Res; 23(19); 5696-702. ©2017 AACR.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Carcinoma de Células Escamosas / Cisplatino / Viroterapia Oncolítica / Neoplasias de Cabeza y Cuello Límite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Clin Cancer Res Asunto de la revista: NEOPLASIAS Año: 2017 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Carcinoma de Células Escamosas / Cisplatino / Viroterapia Oncolítica / Neoplasias de Cabeza y Cuello Límite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Clin Cancer Res Asunto de la revista: NEOPLASIAS Año: 2017 Tipo del documento: Article Pais de publicación: Estados Unidos