Publications associated with TITE CRM Trials


  • Braun TM: “The Bayesian Continual Reassessment Method Using a Mixture-of-Uniforms Prior.”  Submitted, Bayesian Analysis, 2013.
  • Braun TM, Jia N: “A Generalized Continual Reassessment Method for Two-Agent Phase I Trials.”  Submitted, Statistics in Biopharmaceutical Research, 2013.
  • Schott AF, Landis MD, Dontu G, Griffith KA, Layman RM, Krop I, Paskett LA, Wong H, Dobrolecki LE, Froehlich AM, Paranilam J, Hayes DF, Wicha MS, and Chang JC: “Preclinical and Clinical Studies of Gamma Secretase Inhibitors with Docetaxel on Human Breast Tumors. Clin Cancer Res, 19:1512-1524, 2013, (UMCC 2006.119).
  • Zhang J, Braun TM, Taylor JMG: "Adaptive Prior Variance Calibration in the Bayesian Continual Reassessment Method."  Stat Med, 32(13):2221-34, 2013, PMC3561509.


  • Ben-Josef E, Schipper M, Francis IR, Hadley S, Ten-Haken R, Lawrence T, Normolle D, Simeone DM, Sonnenday C, Abrams R, Leslie W, Khan G, Zalupski MM: “A Phase I/II Trial of Intensity Modulated Radiation (IMRT) Dose Escalation with Concurrent Fixed-dose Rate Gemcitabine (FDR-G) in Patients with Unresectable Pancreatic Cancer.”  Int J Radiat Oncol Biol Phys, 84(5):1166-7, 2012, PMC3421048.
  • Feng M. Smith DE, Normolle DP, Knol JA, Pan CC, Ben-Josef E, Lu Z, Feng MR, Chen J, Ensminger W, Lawrence TS: “A Phase I Clinical and Pharmacology Study Using Amifostine as a Radioprotector in Dose-escalated Whole Liver Radiation Therapy.”  Int J Radiat Oncol Biol Phys, 83(5): 1441-7, 2012, PMC3383372.
  • Jakubowiak AJ, Dytfeld D, Griffith KA, Lebovic D, Vesole DH, Jagannath S, Al-Zoubi A, Anderson T, Nordgren B, Detweiler-Short K, Stockerl-Goldstein K, Ahmed A, Jobkar T, Durecki D, McDonnell, Mietzel M, Couriel D, Kaminski M, and Vij R: “A phase I/2 study of carfilzomib in combination with lenalidomide and low-dose dexamethasone as a frontline treatment for multiple myeloma.”  Blood, 120:1801-9, 2012, (UMCC 2009.056).
  • Tsien CI, Brown D, Normolle D, Schipper M, Morand P, Junck L, Heth JA, Gomez-Hassan D, Ten-Haken R, Chenevert TL, Cao Y, Lawrence TS: "Concurrent Temozolomide and Dose-Escalated Intensity Modulated Radiation Therapy in Newly Diagnosed Glioblastoma." Clin Cancer Res. 18(1):273-9, 2012, PMC3266840.


  • Braun TM, Alonzo TA: “Beyond the 3+3 method: expanded algorithms for dose escalation in Phase I oncology trials of two agents.”  Clin Trials 8(3):247-59, 2011, PMC in process.
  • Jakubowiak AJ, Griffith KA, Reece DE, Hofmeister SL, Zimmerman TM, Campagnaro EL, Schlossman RL, Lauback JP, Raje NS, Anderson T, Hill M, Harvey C, Wear S, Barrickman J, Tendler C, Esseltine DL, Kelly SL, Kaminski MS, Anderson KC, and Richardson PG: “Lenalidomide, Bortezomib, Pegylated Liposomal Doxorubicin, and Dexamethasone in Newly Diagnosed Multiple Myeloma: a Phase I/II Multiple Myeloma Research Consortium Trial”. Blood 118(3):535-543, 2011, (UMCC 2007.098)
  • Jia N, Braun TM: “The Adaptive Accelerated Biased Coin Design for Phase I Clinical Trials.” J Applied Stat, 12:2911-24, 2011.
  • Zhao L, Lee J, Mody R, Braun TM: "The superiority of the time-to-event continual reassessment method to the rolling six design in pediatric oncology Phase I trials."  Clin Trials 8(4): 361-9, 2011.
  • Schneider BJ, Kalemkerian GP, Bradley D, Smith DC, Egorin MJ, Daignault S, Dunn R, Hussain M. “Phase I study of vorinostat (suberoylanilide hydroxamic acid, NSC 701852) in combination with docetaxel in patients with advanced and relapsed solid malignancies.” Invest New Drugs. 2010, (UMCC 2006.026)


  • Normolle, D., Lawrence, T: “Designing Dose Escalation Trials with Late Onset Toxicities Using the Time-to-Event Continual Reassessment Method.”  J Clin Oncol 24:  4426-4433, 2006.
  • Ben-Josef, E, Normolle, D, Pan, C, Tatro, D, Ten Haken, R, Knol, J, Walker, S, Dawson, L, Ensminger, W, Lawrence, T: “High-dose Conformal Radiation Therapy with Concurrent Hepatic Artery Fluorodeoxyuridine for Unresectable Intrahepatic Malignancies.”  J Clin Oncol 23(34): 8739-47, 2005.
  • Muler, J, McGinn, C, Normolle, D, Lawrence, T, Brown, D, Hejna, G, Zalupski, M: “A Phase I Trial Using the Time-to-Event Continual Reassessment Strategy to Escalate Cisplatin with Gemacitabine and Radiation Therapy for Pancreatic Cancer.”  J Clin Oncol, 22: 238-243, 2004.
  • McGinn,C, Zalupski, M, Shureiqi, I, Robertson, J, Eckhauser, F, Smith, D, Decker, D, Neumann, K, Brown, D, Hejna, G, Strawderman, M, Normolle, D, Lawrence, T: “A phase I trial of radiation dose escalation with concurrent weekly full dose Gemcitabine in patients with advanced pancreatic cancer.”  J Clin Oncol, 19(22) 4202-8, 2001.