A Phase 1 Study of Pevonedistat (MLN4924) a Cullin Ligase Inhibitor in Combination With Temozolomide and Irinotecan in Pediatric Patients With Recurrent or Refractory Solid Tumors

Study Overview

This phase I trial studies the side effects and best dose of pevonedistat when giving together with irinotecan hydrochloride and temozolomide in treating patients with solid tumors or lymphoma that have come back after a period of improvement or that do not respond to treatment.

Study Description

The purpose of this study is to estimate the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of pevonedistat administered as an intravenous infusion on days 1, 8, 10, and 12 of a 28-day cycle (cycle 1), and on days 1, 3, and 5 of a 21-day cycle (cycle 2 and beyond) in combination with irinotecan hydrochloride (irinotecan) (administered as an intravenous infusion on days 8-12 of cycle 1 and days 1-5 of cycles 2+) and temozolomide (administered orally on day 1 alone and on days 8, 10 and 12 in cycle 1 and days 1-5 of cycles 2+) in children with recurrent or refractory solid tumors, including central nervous system (CNS) tumors and lymphoma; to define and describe the toxicities of pevonedistat administered on this schedule; and to characterize the pharmacokinetics of pevonedistat in children with recurrent or refractory cancer.

Additional Information

Participants will not be paid for their participation.

  • IRB Number: 1712549832 (PHO-CROOP-COG-ADVL1615)
  • Research Study Identifier: TX8562
  • Principal Investigator: James Croop, MD, PhD

Recruitment Status


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