Clinical trialNCT00528437CompletedPhase 2Interventional

Temozolomide,Thiotepa and Carboplatin With Autologous Stem Cell Rescue Followed by 13-cis-retinoic Acid in Patients With Recurrent/Refractory Malignant Brain Tumors

SponsorNYU Langone HealthEnrollment46Brain Tumors

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The purpose of this study is to: Find out how safe and effective (by monitoring the good and/or bad effects) treatment with high dose temozolomide, thiotepa and carboplatin with stem cell rescue followed by 13-cis-retinoic acid has on children and adolescents with recurrent/refractory brain tumors Find out how the body uses 13-cis-retinoic acid by studying the your blood levels and proteins in the blood that break down the 13-cis-retinoic acid Determine how well 13-cis-retinoic acid penetrates into the spinal fluid.

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Investigators

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

Sharon L Gardner, MD
NYU Langone Health
Principal Investigator
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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

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

Canada

Princess Margaret Hospital
Toronto, Ontario, Canada

United States

Phoenix Children'S Hospital
Phoenix, Arizona, United States
Emory University
Atlanta, Georgia, United States
Hawaii Pacific Health
Lihue, Hawaii, United States
Children'S Memorial Hospital
Chicago, Illinois, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
Children'S Hospital and Clinics of Minnesota
Minneapolis, Minnesota, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Steven and Alexandra Cohen Children'S Medical Center of New York- North Shore Lij
New Hyde Park, New York, United States
Nyu Hassenfeld Center
New York, New York, United States
Nationwide Children'S Hospital
Columbus, Ohio, United States
Children'S Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Medical Univ. of South Carolina
Charleston, South Carolina, United States
Vanderbilt Univ.
Nashville, Tennessee, United States
Children'S Medical Center of Dallas
Dallas, Texas, United States
Md Anderson Cancer Center (mdacc)
Houston, Texas, United States
Virginia Commonwealth Univ.
Richmond, Virginia, 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.

Temozolomide →

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: 31 Oct 2005
Primary completion: 30 Jun 2017
Completion: 30 Dec 2017
Last update posted: 8 Jul 2021
Registered enrollment: 46
Registry id: NCT00528437

clinicaltrials.gov ↗

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.