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A feasibility study of combined epigenetic and vaccine therapy in advanced colorectal cancer with pharmacodynamic endpoint.
Bever, Katherine M; Thomas, Dwayne L; Zhang, Jiajia; Diaz Rivera, Ernie A; Rosner, Gary L; Zhu, Qingfeng; Nauroth, Julie M; Christmas, Brian; Thompson, Elizabeth D; Anders, Robert A; Judkins, Carol; Liu, Meizheng; Jaffee, Elizabeth M; Ahuja, Nita; Zheng, Lei; Azad, Nilofer S.
Afiliación
  • Bever KM; Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, Bloomberg~Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University School of Medicine, 1650 Orleans Street, Office 4M10, Baltimore, MD, 21287, USA.
  • Thomas DL; Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, Bloomberg~Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University School of Medicine, 1650 Orleans Street, Office 4M10, Baltimore, MD, 21287, USA.
  • Zhang J; Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
  • Diaz Rivera EA; Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, Bloomberg~Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University School of Medicine, 1650 Orleans Street, Office 4M10, Baltimore, MD, 21287, USA.
  • Rosner GL; Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, Bloomberg~Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University School of Medicine, 1650 Orleans Street, Office 4M10, Baltimore, MD, 21287, USA.
  • Zhu Q; Division of Biostatistics and Bioinformatics, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
  • Nauroth JM; Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, Bloomberg~Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University School of Medicine, 1650 Orleans Street, Office 4M10, Baltimore, MD, 21287, USA.
  • Christmas B; Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, Bloomberg~Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University School of Medicine, 1650 Orleans Street, Office 4M10, Baltimore, MD, 21287, USA.
  • Thompson ED; Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, Bloomberg~Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University School of Medicine, 1650 Orleans Street, Office 4M10, Baltimore, MD, 21287, USA.
  • Anders RA; Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, Bloomberg~Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University School of Medicine, 1650 Orleans Street, Office 4M10, Baltimore, MD, 21287, USA.
  • Judkins C; Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
  • Liu M; Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
  • Jaffee EM; Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, Bloomberg~Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University School of Medicine, 1650 Orleans Street, Office 4M10, Baltimore, MD, 21287, USA.
  • Ahuja N; Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, Bloomberg~Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University School of Medicine, 1650 Orleans Street, Office 4M10, Baltimore, MD, 21287, USA.
  • Zheng L; Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, Bloomberg~Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University School of Medicine, 1650 Orleans Street, Office 4M10, Baltimore, MD, 21287, USA.
  • Azad NS; Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, Bloomberg~Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University School of Medicine, 1650 Orleans Street, Office 4M10, Baltimore, MD, 21287, USA.
Clin Epigenetics ; 13(1): 25, 2021 02 02.
Article en En | MEDLINE | ID: mdl-33531075
ABSTRACT
Epigenetic therapies may modulate the tumor microenvironment. We evaluated the safety and optimal sequence of combination DNA methyltransferase inhibitor guadecitabine with a granulocyte macrophage-colony-stimulating-factor (GM-CSF) secreting colon cancer (CRC) vaccine (GVAX) using a primary endpoint of change in CD45RO + T cells. 18 patients with advanced CRC enrolled, 11 underwent paired biopsies and were evaluable for the primary endpoint. No significant increase in CD45RO + cells was noted. Grade 3-4 toxicities were expected and manageable. Guadecitabine + GVAX was tolerable but demonstrated no significant immunologic activity in CRC. We report a novel trial design to efficiently evaluate investigational therapies with a primary pharmacodynamic endpoint.Trial registry Clinicaltrials.gov NCT01966289. Registered 21 October, 2013.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Azacitidina / Neoplasias Colorrectales / Vacunas contra el Cáncer / ADN (Citosina-5-)-Metiltransferasa 1 Tipo de estudio: Clinical_trials Límite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Clin Epigenetics Año: 2021 Tipo del documento: Article País de afiliación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Azacitidina / Neoplasias Colorrectales / Vacunas contra el Cáncer / ADN (Citosina-5-)-Metiltransferasa 1 Tipo de estudio: Clinical_trials Límite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Clin Epigenetics Año: 2021 Tipo del documento: Article País de afiliación: Estados Unidos