Nanoparticle Albumin-Bound Rapamycin, Temozolomide, and Irinotecan Hydrochloride in Treating Pediatric Patients With Recurrent or Refractory Solid Tumors

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Children's Oncology Group
Study ID
NCT02975882
Phase
PHASE1
Status
Completed

Conditions

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

Eligibility Criteria

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

Interventions

  • Irinotecan Hydrochloride — DRUG
    Given PO
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Pharmacological Study — OTHER
    Correlative studies
  • Sirolimus Albumin-bound Nanoparticles — DRUG
    Given IV
  • Temozolomide — DRUG
    Given PO

Study Details

This phase I trial studies the side effects and best dose of nanoparticle albumin-bound rapamycin when given together with temozolomide and irinotecan hydrochloride in treating pediatric patients with solid tumors that have come back after treatment and a period of time during which the tumor could not be detected or has not responded to treatment. Nanoparticle albumin-bound rapamycin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as temozolomide and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nanoparticle albumin-bound rapamycin, temozolomide, and irinotecan hydrochloride may cause the cancer to stop growing or shrink for a period of time and may lessen the symptoms that are caused by the cancer.

Key Dates

Start date
Aug 15, 2017
Status verified
Jan 2025
Primary completion
Mar 31, 2022
Completion
Dec 31, 2024

Study Design

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

Arms

  • Experimental: Treatment (nab-rapamycin, temozolomide, irinotecan)
    Patients receive nanoparticle albumin-bound rapamycin IV over 30 minutes on days 1 and 8 beginning on cycle 1. Patients also receive temozolomide PO and irinotecan hydrochloride PO on days 1-5 beginning on cycle 2. Treatment repeats every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Number of Patients With Cycle 1 and 2 Dose Limiting Toxicities Attributable to Nanoparticle Albumin-bound Rapamycin [ Time Frame: Up to 42 days ]

Locations (21)

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-
Prisma Health Richland HospitalColumbiaSouth Carolina29203-
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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