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Completed Phase 3 Interventional

High-Dose Chemotherapy Plus Autologous Stem Cell Transplantation Compared With Intermediate-Dose Chemotherapy Plus Autologous Stem Cell Transplantation With or Without Isotretinoin in Treating Young Patients With Recurrent High-Grade Gliomas

ClinicalTrials.gov ID: NCT00078988

Public ClinicalTrials.gov record NCT00078988. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 25, 2026, 3:54 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase III Randomized Trial for the Treatment of Pediatric High Grade Gliomas at First Recurrence With a Single High Dose Chemotherapy and Autologous Stem Cell Transplant Versus Three Courses of Intermediate Dose Chemotherapy With Peripheral Blood Stem Cell (PBSC) Support

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

RATIONALE: Drugs used in chemotherapy, such as carboplatin, thiotepa, and etoposide, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with autologous stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Isotretinoin may be effective in preventing recurrence of glioma. It is not yet known which regimen of chemotherapy plus autologous stem cell transplantation with or without isotretinoin is more effective in treating recurrent high-grade glioma. PURPOSE: This randomized phase III trial is studying high-dose chemotherapy or intermediate-dose chemotherapy followed by autologous stem cell transplantation to see how well it works compared to high-dose chemotherapy or intermediate-dose chemotherapy followed by autologous stem cell transplantation and isotretinoin in treating young patients with recurrent high-grade glioma.

Study identification

NCT ID
NCT00078988
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Children's Oncology Group
Network
Enrollment
1 participant

Conditions and interventions

Eligibility (public fields only)

Age range
Up to 20 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 2004 (Type not available)
Primary completion
Sep 2006 (Actual)
Completion
Sep 2006 (Actual)
Last update posted
May 7, 2015

2004 – 2006

United States locations

U.S. sites
52
U.S. states
26
U.S. cities
48
Facility City State ZIP Site status
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock Arkansas 72205 —
Children's Hospital and Research Center - Oakland Oakland California 94609-1809 —
University of California Davis Cancer Center Sacramento California 95817 —
Children's Hospital and Health Center - San Diego San Diego California 92123-4282 —
Children's Hospital Cancer Center Denver Colorado 80218-1088 —
Children's National Medical Center Washington D.C. District of Columbia 20010-2970 —
University of Florida Shands Cancer Center Gainesville Florida 32610-0232 —
Nemours Children's Clinic Jacksonville Florida 32207 —
University of Miami Sylvester Comprehensive Cancer Center Miami Florida 33136 —
Miami Children's Hospital Miami Florida 33155 —
All Children's Hospital St. Petersburg Florida 33701 —
St. Joseph's Cancer Institute at St. Joseph's Hospital Tampa Florida 33607 —
Kaplan Cancer Center at St. Mary's Medical Center West Palm Beach Florida 33407 —
Emory University Hospital - Atlanta Atlanta Georgia 30322 —
Cancer Research Center of Hawaii Honolulu Hawaii 95813 —
Indiana University Cancer Center Indianapolis Indiana 46202-5289 —
St. Vincent Indianapolis Hospital Indianapolis Indiana 46260 —
Kosair Children's Hospital Louisville Kentucky 40232 —
CancerCare of Maine at Eastern Maine Medial Center Bangor Maine 04401 —
Floating Hospital for Children at Tufts - New England Medical Center Boston Massachusetts 02111 —
Barbara Ann Karmanos Cancer Institute Detroit Michigan 48201-1379 —
Spectrum Health Cancer Care - Butterworth Campus Grand Rapids Michigan 49503-2560 —
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods Michigan 48236 —
Children's Hospital of Minnesota - Minneapolis Minneapolis Minnesota 55404 —
Fairview University Medical Center - University Campus Minneapolis Minnesota 55455 —
University of Mississippi Medical Center Jackson Mississippi 39216-4505 —
Children's Mercy Hospital Kansas City Missouri 64108 —
Siteman Cancer Center at Barnes-Jewish Hospital St Louis Missouri 63110 —
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School New Brunswick New Jersey 08903 —
Roswell Park Cancer Institute Buffalo New York 14263-0001 —
NYU Cancer Institute at New York University Medical Center New York New York 10016 —
Herbert Irving Comprehensive Cancer Center at Columbia University New York New York 10032 —
James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester New York 14642 —
SUNY Upstate Medical University Hospital Syracuse New York 13210 —
New York Medical College Valhalla New York 10595 —
Children's Hospital Medical Center of Akron Akron Ohio 44308-1062 —
Cincinnati Children's Hospital Medical Center Cincinnati Ohio 45229-3039 —
Rainbow Babies and Children's Hospital Cleveland Ohio 44106-5000 —
Columbus Children's Hospital Columbus Ohio 43205-2696 —
Children's Medical Center - Dayton Dayton Ohio 45404-1815 —
Oklahoma University Medical Center Oklahoma City Oklahoma 73104 —
Penn State Cancer Institute at Milton S. Hershey Medical Center Hershey Pennsylvania 17033-0850 —
Hollings Cancer Center at Medical University of South Carolina Charleston South Carolina 29425 —
Sioux Valley Hospital and University of South Dakota Medical Center Sioux Falls South Dakota 57117-5039 —
Cook Children's Medical Center - Fort Worth Fort Worth Texas 76104-9958 —
Covenant Children's Hospital Lubbock Texas 79410 —
Primary Children's Medical Center Salt Lake City Utah 84113-1100 —
INOVA Fairfax Hospital Fairfax Virginia 22031 —
Children's Hospital of the King's Daughters Norfolk Virginia 23507-1971 —
Massey Cancer Center at Virginia Commonwealth University Richmond Virginia 23298-0037 —
University of Wisconsin Comprehensive Cancer Center Madison Wisconsin 53792-6164 —
Marshfield Clinic - Marshfield Center Marshfield Wisconsin 54449 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00078988, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 7, 2015 · Synced Oct 25, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00078988 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →