title: First-in-Human Phase 1 Trial of Agarose Beads Containing Murine RENCA Cells in Advanced Solid Tumors.
abstract: OBJECTIVE
  Agarose macrobeads containing mouse renal adenocarcinoma cells (RMBs) release factors, suppressing the growth of cancer cells and prolonging survival in spontaneous or induced tumor animals, mediated, in part, by increased levels of myocyte-enhancing factor (MEF2D) via EGFR-and AKT-signaling pathways. The primary objective of this study was to determine the safety of RMBs in advanced, treatment-resistant metastatic cancers, and then its efficacy (survival), which is the secondary objective.
  
  
  METHODS
  Thirty-one patients underwent up to four intraperitoneal implantations of RMBs (8 or 16 macrobeads/kg) via laparoscopy in this single-arm trial (FDA BB-IND 10091; NCT 00283075). Serial physical examinations, laboratory testing, and PET-CT imaging were performed before and three months after each implant.
  
  
  RESULTS
  RMBs were well tolerated at both dose levels (mean 660.9 per implant). AEs were (Grade 1/2) with no treatment-related SAEs.
  
  
  CONCLUSIONS
  The data support the safety of RMB therapy in advanced-malignancy patients, and the preliminary evidence for their potential efficacy is encouraging. A Phase 2 efficacy trial is ongoing.
authors: The Rogosin Institute, Cancer Research, New York, NY, USA.
authors: Barry H
authors: BH
authors: Smith
authors: The Rogosin Institute, Cancer Research, New York, NY, USA.
authors: Tapan
authors: T
authors: Parikh
authors: The Rogosin Institute, Cancer Research, New York, NY, USA.
authors: Zoe P
authors: ZP
authors: Andrada
authors: New York Presbyterian-Weill Cornell Medical Center, New York, NY, USA.
authors: Thomas J
authors: TJ
authors: Fahey
authors: New York Presbyterian-Weill Cornell Medical Center, New York, NY, USA.
authors: Nathaniel
authors: N
authors: Berman
authors: The Rogosin Institute, Xenia Division, Xenia, OH, USA.
authors: Madeline
authors: M
authors: Wiles
authors: The Rogosin Institute, Cancer Research, New York, NY, USA.
authors: Angelica
authors: A
authors: Nazarian
authors: The Rogosin Institute, Cancer Research, New York, NY, USA.
authors: Joanne
authors: J
authors: Thomas
authors: The Rogosin Institute, Cancer Research, New York, NY, USA.
authors: Anna
authors: A
authors: Arreglado
authors: The Rogosin Institute, Cancer Research, New York, NY, USA.
authors: Eugene
authors: E
authors: Akahoho
authors: The Rogosin Institute, Cancer Research, New York, NY, USA.
authors: David J
authors: DJ
authors: Wolf
authors: The Rogosin Institute, Cancer Research, New York, NY, USA.
authors: Daniel M
authors: DM
authors: Levine
authors: The Rogosin Institute, Cancer Research, New York, NY, USA.
authors: Thomas S
authors: TS
authors: Parker
authors: The Rogosin Institute, Xenia Division, Xenia, OH, USA.
authors: Lawrence S
authors: LS
authors: Gazda
authors: New York Presbyterian-Weill Cornell Medical Center, New York, NY, USA.
authors: Allyson J
authors: AJ
authors: Ocean
keywords: cancer clinical trial; cancer system biology; cell-based therapeutics; colorectal cancer treatment; gastrointestinal cancer; solid tumors