ADVL1615, A Phase 1 Study of Pevonedistat (MLN4924, IND# 136078), a NEDD8 Activating Enzyme (NAE) Inhibitor, in Combination with Temozolomide and Irinotecan in Pediatric Patients with Recurrent or Refractory Solid Tumors

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. Pevonedistat and irinotecan hydrochloride may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pevonedistat, irinotecan hydrochloride, and temozolomide may work better in treating patients with solid tumors or lymphoma.

Principal Investigator:
Ivan Kirov, MD

Research Coordinator:
Tina Templeman, RN
(714) 509-8646

Visit clinicaltrials.gov for more information about this trial.



  • Clinical Trial Info
  • IRB Number: 1711130
  • Sponsor: Children's Oncology Group
  • Protocol Number: ADVL1615
  • NCT Number: NCT03323034
  • Research Type: Adolescents and Young Adults, Brain Tumor/Central Nervous System/Neuro-Oncology, Recurrent/Refractory Cancer, Solid Tumors
  • Phase: I
  • Status: Active - Open to Enrollment

Key Inclusion Criteria:

  • Age: 12 months to 21 Years
  • Patients with recurrent or refractory solid tumors, including CNS tumors and lymphoma, are eligible; patients must have had histologic verification of malignancy at original diagnosis or relapse except in patients with intrinsic brain stem tumors, optic pathway gliomas, or patients with pineal tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG)
  • Standard COG Phase 1 organ function requirements

Key Exclusion Criteria:

  • Patients with uncontrolled high blood pressure (i.e., systolic blood pressure > 99th percentile) are not eligible
  • Patients with known cardiopulmonary disease are not eligible
  • Patients with known hepatic cirrhosis or severe pre-existing hepatic impairment are not eligible
  • Patients with uncontrolled coagulopathy or bleeding disorder are not eligible

Facebook Twitter Pinterest Instagram Snapchat LinkedIn YouTube RSS

 

UC Irvine

CHOC Children's is affiliated with the UC Irvine School of Medicine