Pevonedistat, Irinotecan, and Temozolomide in Treating Patients With Recurrent or Refractory Solid Tumors or Lymphoma

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Children's Oncology Group
Study ID
NCT03323034
Phase
PHASE1
Status
Completed

Conditions

  • Recurrent Lymphoma
  • Recurrent Malignant Solid Neoplasm
  • Recurrent Primary Central Nervous System Neoplasm
  • Refractory Lymphoma
  • Refractory Malignant Solid Neoplasm
  • Refractory Primary Central Nervous System Neoplasm

Eligibility Criteria

Sex
ALL
Age
6 Months - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan — DRUG
    Given IV
  • Pevonedistat — DRUG
    Given IV
  • Temozolomide — DRUG
    Given PO

Study Details

This phase I trial studies the side effects and best dose of pevonedistat when given together with irinotecan hydrochloride and temozolomide in treating patients with solid tumors, central nervous system (CNS) tumors, or lymphoma that have come back after a period of improvement (recurrent) or that do not respond to treatment (refractory). Pevonedistat and irinotecan 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, central nervous system (CNS) tumors, or lymphoma compared to irinotecan and temozolomide alone.

Key Dates

Start date
Jan 11, 2018
Status verified
Oct 2024
Primary completion
Sep 30, 2021
Completion
Sep 30, 2024

Study Design

Enrollment
30 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (pevonedistat, temozolomide, irinotecan)
    Patients receive pevonedistat IV over 60 minutes on days 1, 8, 10, and 12, temozolomide PO daily on days 8-12, and irinotecan IV over 90 minutes on days 8-12 of cycle 1. Beginning cycle 2, patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5, temozolomide PO daily on days 1-5, and irinotecan IV over 90 minutes on days 1-5. Treatment repeats every 28 days for cycle 1 and 21 days for subsequent cycles for up to 17 cycles in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

MTD/RP2D of Pevonedistat in Combination With Irinotecan and Temozolomide [ Time Frame: Up to 28 days ]

Locations (20)

FacilityCityStateZIPSite coordinators
Children's Hospital of AlabamaBirminghamAlabama35233-
Children's Hospital Los AngelesLos AngelesCalifornia90027-
Children's Hospital of Orange CountyOrangeCalifornia92868-
UCSF Medical Center-Mission BaySan FranciscoCalifornia94158-
Children's Hospital ColoradoAuroraColorado80045-
Children's National Medical CenterWashington D.C.District of Columbia20010-
Children's Healthcare of Atlanta - Arthur M Blank HospitalAtlantaGeorgia30329-
Lurie Children's Hospital-ChicagoChicagoIllinois60611-
Riley Hospital for ChildrenIndianapolisIndiana46202-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
C S Mott Children's HospitalAnn ArborMichigan48109-
University of Minnesota/Masonic Cancer CenterMinneapolisMinnesota55455-
Washington University School of MedicineSt LouisMissouri63110-
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterNew YorkNew York10032-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
Children's Hospital of Pittsburgh of UPMCPittsburghPennsylvania15224-
Saint Jude Children's Research HospitalMemphisTennessee38105-
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer CenterHoustonTexas77030-
Seattle Children's HospitalSeattleWashington98105-

Find similar trials in Birmingham, AL

By research site
Children's Hospital of Alabama· Birmingham, ALChildren's Hospital Los Angeles· Los Angeles, CAChildren's Hospital of Orange County· Orange, CAUCSF Medical Center-Mission Bay· San Francisco, CAChildren's Hospital Colorado· Aurora, COChildren's National Medical Center· Washington D.C., DC

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