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Clinical trialNCT02975882CompletedPhase 1Interventional

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

SponsorChildren's Oncology GroupEnrollment33Childhood Solid NeoplasmRecurrent Malignant Solid NeoplasmRecurrent Primary Central Nervous System NeoplasmRefractory Malignant Solid NeoplasmRefractory Primary Central Nervous System Neoplasm
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

21 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Children'S Hospital of Alabama

    Birmingham, Alabama, United States

  • Children'S Hospital Los Angeles

    Los Angeles, California, United States

  • Children'S Hospital of Orange County

    Orange, California, United States

  • Ucsf Medical Center-Mission Bay

    San Francisco, California, United States

  • Children'S Hospital Colorado

    Aurora, Colorado, United States

  • Children'S National Medical Center

    Washington D.C., District of Columbia, United States

  • Children'S Healthcare of Atlanta - Arthur M Blank Hospital

    Atlanta, Georgia, United States

  • Lurie Children'S Hospital-Chicago

    Chicago, Illinois, United States

  • Riley Hospital for Children

    Indianapolis, Indiana, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, United States

  • C S Mott Children'S Hospital

    Ann Arbor, Michigan, United States

  • University of Minnesota/masonic Cancer Center

    Minneapolis, Minnesota, United States

  • Washington University School of Medicine

    St Louis, Missouri, United States

  • Nyp/columbia University Medical Center/herbert Irving Comprehensive Cancer Center

    New York, New York, United States

  • Cincinnati Children'S Hospital Medical Center

    Cincinnati, Ohio, United States

  • Children'S Hospital of Philadelphia

    Philadelphia, Pennsylvania, United States

  • Children'S Hospital of Pittsburgh of Upmc

    Pittsburgh, Pennsylvania, United States

  • Prisma Health Richland Hospital

    Columbia, South Carolina, United States

  • Saint Jude Children'S Research Hospital

    Memphis, Tennessee, United States

  • Baylor College of Medicine/dan L Duncan Comprehensive Cancer Center

    Houston, Texas, United States

  • Seattle Children'S Hospital

    Seattle, Washington, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

IrinotecanSirolimus Albumin-bound NanoparticlesTemozolomide
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
15 Aug 2017
Primary completion
31 Mar 2022
Completion
31 Dec 2024
Last update posted
14 Jan 2025
Registered enrollment
33
Registry id
NCT02975882

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.