search
Back to results

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

Primary Purpose

Brain Tumor, Central Nervous System Tumor

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
filgrastim
carboplatin
etoposide
isotretinoin
thiotepa
autologous bone marrow transplantation
peripheral blood stem cell transplantation
Sponsored by
Children's Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Tumor focused on measuring childhood high-grade cerebral astrocytoma, recurrent childhood cerebellar astrocytoma, recurrent childhood cerebral astrocytoma

Eligibility Criteria

undefined - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed diagnosis of 1 of the following high-grade gliomas: Glioblastoma multiforme Anaplastic astrocytoma Gliosarcoma Disease in first relapse No primary brainstem or spinal cord gliomas No secondary glioblastomas arising after prior treatment for a non-glial tumor Prior local radiotherapy of 5,000-6,000 cGy required Less than 1.5 cm of residual gadolinium-enhancing tumor in maximal cross-sectional diameter by MRI No metastatic tumor by spinal MRI PATIENT CHARACTERISTICS: Age Under 21 at diagnosis Performance status Lansky 50-100% OR Karnofsky 50-100% Life expectancy Not specified Hematopoietic Absolute neutrophil count ≥ 500/mm^3 Platelet count ≥ 100,000/mm^3 (transfusion independent) Hepatic Bilirubin ≤ 1.5 times upper limit of normal (ULN) AST or ALT < 2.5 times ULN Renal Glomerular filtration rate ≥ 60 mL/min AND/OR Creatinine clearance ≥ 60 mL/min Cardiovascular Shortening fraction ≥ 27% by echocardiogram OR Ejection fraction ≥ 50% by MUGA Pulmonary No dyspnea at rest No exercise intolerance Pulse oximetry > 94% Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy More than 4 weeks since prior chemotherapy No prior thiotepa No prior myeloablative chemotherapy Endocrine therapy No concurrent corticosteroids Radiotherapy See Disease Characteristics More than 8 weeks since prior radiotherapy No prior craniospinal radiotherapy Surgery Not specified

Sites / Locations

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
  • Children's Hospital and Research Center - Oakland
  • University of California Davis Cancer Center
  • Children's Hospital and Health Center - San Diego
  • Children's Hospital Cancer Center
  • Children's National Medical Center
  • University of Florida Shands Cancer Center
  • Nemours Children's Clinic
  • University of Miami Sylvester Comprehensive Cancer Center
  • Miami Children's Hospital
  • All Children's Hospital
  • St. Joseph's Cancer Institute at St. Joseph's Hospital
  • Kaplan Cancer Center at St. Mary's Medical Center
  • Emory University Hospital - Atlanta
  • Cancer Research Center of Hawaii
  • Indiana University Cancer Center
  • St. Vincent Indianapolis Hospital
  • Kosair Children's Hospital
  • CancerCare of Maine at Eastern Maine Medial Center
  • Floating Hospital for Children at Tufts - New England Medical Center
  • Barbara Ann Karmanos Cancer Institute
  • Spectrum Health Cancer Care - Butterworth Campus
  • Van Elslander Cancer Center at St. John Hospital and Medical Center
  • Children's Hospital of Minnesota - Minneapolis
  • Fairview University Medical Center - University Campus
  • University of Mississippi Medical Center
  • Children's Mercy Hospital
  • Siteman Cancer Center at Barnes-Jewish Hospital
  • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
  • Roswell Park Cancer Institute
  • NYU Cancer Institute at New York University Medical Center
  • Herbert Irving Comprehensive Cancer Center at Columbia University
  • James P. Wilmot Cancer Center at University of Rochester Medical Center
  • SUNY Upstate Medical University Hospital
  • New York Medical College
  • Children's Hospital Medical Center of Akron
  • Cincinnati Children's Hospital Medical Center
  • Rainbow Babies and Children's Hospital
  • Columbus Children's Hospital
  • Children's Medical Center - Dayton
  • Oklahoma University Medical Center
  • Penn State Cancer Institute at Milton S. Hershey Medical Center
  • Hollings Cancer Center at Medical University of South Carolina
  • Sioux Valley Hospital and University of South Dakota Medical Center
  • Cook Children's Medical Center - Fort Worth
  • Covenant Children's Hospital
  • Primary Children's Medical Center
  • INOVA Fairfax Hospital
  • Children's Hospital of the King's Daughters
  • Massey Cancer Center at Virginia Commonwealth University
  • University of Wisconsin Comprehensive Cancer Center
  • Marshfield Clinic - Marshfield Center
  • Princess Margaret Hospital for Children
  • Children's & Women's Hospital of British Columbia
  • McMaster Children's Hospital at Hamilton Health Sciences
  • Hospital for Sick Children
  • Montreal Children's Hospital at McGill University Health Center
  • Hopital Sainte Justine
  • Centre Hospitalier Universitaire de Quebec

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Arm I (high-dose chemotherapy and ASCR)

Arm II (intermediate-dose chemotherapy and ASCR)

Arm III (isotretinoin)

Arm IV (no isotretinoin)

Arm Description

Patients receive high-dose chemotherapy comprising carboplatin IV over 4 hours on days -8 to -6; thiotepa IV over 3 hours and etoposide IV over 3 hours on days -5 to -3; and filgrastim (G-CSF) IV or SC once daily beginning on day 1 and continuing until blood counts recover. Autologous PBSC or bone marrow are reinfused on day 0.

Patients receive intermediate-dose chemotherapy comprising carboplatin IV over 4 hours and thiotepa IV over 3 hours on days 1-2 and G-CSF IV or SC once daily beginning on day 4 and continuing until blood counts recover. Autologous PBSC or bone marrow are reinfused on day 3. Treatment repeats every 28 days for a total of 3 courses.

Patients receive oral isotretinoin twice daily on days 1-14. Treatment repeats every 28 days for a total of 6 courses.

Patients do not receive maintenance therapy.

Outcomes

Primary Outcome Measures

Event-free survival
The primary endpoint for the evaluation of treatment efficacy will be event-free survival (EFS)
Toxic death attributable to complications of treatment in the absence of tumor progression as assessed by NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0
Toxic death will be monitored separately in each of the two chemotherapy groups

Secondary Outcome Measures

Overall survival (OS)
Secondary endpoints include overall survival (OS), which is defined as the time from study entry to death from any cause, assessed up to 4 years

Full Information

First Posted
March 8, 2004
Last Updated
May 6, 2015
Sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00078988
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
OBJECTIVES: Compare the event-free survival and overall survival of pediatric patients with recurrent high-grade gliomas treated with a single course of high-dose carboplatin, etoposide, and thiotepa and autologous stem cell transplantation vs multiple courses of intermediate-dose carboplatin and thiotepa and autologous stem cell transplantation with or without isotretinoin. Compare the number of hospital days and time to engraftment in patients treated with these regimens. Compare the toxic death rate in patients treated with these regimens. Compare the tolerability of isotretinoin in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to pathologic diagnosis (glioblastoma multiforme vs anaplastic astrocytoma vs other high-grade glioma). Chemotherapy and autologous stem cell reinfusion (ASCR): Patients are randomized to 1 of 2 treatment arms. Arm I (high-dose chemotherapy and ASCR): Patients receive high-dose chemotherapy comprising carboplatin IV over 4 hours on days -8 to -6; thiotepa IV over 3 hours and etoposide IV over 3 hours on days -5 to -3; and filgrastim (G-CSF) IV or subcutaneously (SC) once daily beginning on day 1 and continuing until blood counts recover. Autologous peripheral blood stem cells (PBSC) or bone marrow are reinfused on day 0. Arm II (intermediate-dose chemotherapy and ASCR): Patients receive intermediate-dose chemotherapy comprising carboplatin IV over 4 hours and thiotepa IV over 3 hours on days 1-2 and G-CSF IV or SC once daily beginning on day 4 and continuing until blood counts recover. Autologous PBSC or bone marrow are reinfused on day 3. Treatment repeats every 28 days for a total of 3 courses. Maintenance therapy: After recovery from chemotherapy (approximately day 30 post-transplantation), all patients are further randomized to 1 of 2 maintenance arms. Arm I: Patients receive oral isotretinoin twice daily on days 1-14. Treatment repeats every 28 days for a total of 6 courses. Arm II: Patients do not receive maintenance therapy. In all arms, treatment continues in the absence of disease progression. Patients are followed every 3 months for 1 year, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 80-150 patients (40-75 per treatment arm) will be accrued for this study within 5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumor, Central Nervous System Tumor
Keywords
childhood high-grade cerebral astrocytoma, recurrent childhood cerebellar astrocytoma, recurrent childhood cerebral astrocytoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (high-dose chemotherapy and ASCR)
Arm Type
Experimental
Arm Description
Patients receive high-dose chemotherapy comprising carboplatin IV over 4 hours on days -8 to -6; thiotepa IV over 3 hours and etoposide IV over 3 hours on days -5 to -3; and filgrastim (G-CSF) IV or SC once daily beginning on day 1 and continuing until blood counts recover. Autologous PBSC or bone marrow are reinfused on day 0.
Arm Title
Arm II (intermediate-dose chemotherapy and ASCR)
Arm Type
Experimental
Arm Description
Patients receive intermediate-dose chemotherapy comprising carboplatin IV over 4 hours and thiotepa IV over 3 hours on days 1-2 and G-CSF IV or SC once daily beginning on day 4 and continuing until blood counts recover. Autologous PBSC or bone marrow are reinfused on day 3. Treatment repeats every 28 days for a total of 3 courses.
Arm Title
Arm III (isotretinoin)
Arm Type
Experimental
Arm Description
Patients receive oral isotretinoin twice daily on days 1-14. Treatment repeats every 28 days for a total of 6 courses.
Arm Title
Arm IV (no isotretinoin)
Arm Type
No Intervention
Arm Description
Patients do not receive maintenance therapy.
Intervention Type
Biological
Intervention Name(s)
filgrastim
Other Intervention Name(s)
Granulocyte Colony-Stimulating Factor, r-metHuG-CSF, G-CSF, Neupogen, NSC 614629
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
carboplatin
Other Intervention Name(s)
Paraplain, CBDCA, NSC #241240
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
etoposide
Other Intervention Name(s)
VP-16, VePesid, Etopophos, NSC #141540
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
isotretinoin
Other Intervention Name(s)
13-cis-retinoic acid, RO-43, 780, Accutane, NSC#329481
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
thiotepa
Other Intervention Name(s)
Tespa, Thiophosphamide, Triethylenethiophosphoramide Tspa, WR-45312, NSC#6396
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
autologous bone marrow transplantation
Other Intervention Name(s)
Stem Cell Reinfusion
Intervention Description
Peripheral blood stem cells or bone marrow will be reinfused about 72 hours following completion of the last dose of chemotherapy (Day 0)
Intervention Type
Procedure
Intervention Name(s)
peripheral blood stem cell transplantation
Other Intervention Name(s)
Peripheral Stem Cell Collection
Intervention Description
Filgrastim is to be given daily in the afternoon for 4 days prior to the first harvest and continued until the completion of the daily harvests. The daily PBSC harvesting should be started prior to the fifth dose of filgrastim.
Primary Outcome Measure Information:
Title
Event-free survival
Description
The primary endpoint for the evaluation of treatment efficacy will be event-free survival (EFS)
Time Frame
om study entry to disease progression, disease relapse, occurrence of a second malignant neoplasm, or death from any cause. assessed up to 4 years
Title
Toxic death attributable to complications of treatment in the absence of tumor progression as assessed by NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0
Description
Toxic death will be monitored separately in each of the two chemotherapy groups
Time Frame
Up to 4 years after completion of study treatment
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
Secondary endpoints include overall survival (OS), which is defined as the time from study entry to death from any cause, assessed up to 4 years
Time Frame
ondary e ndpoints include overall survival (OS), which is defined as the time from study entry to death from any cause assessed up to 4 years

10. Eligibility

Sex
All
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed diagnosis of 1 of the following high-grade gliomas: Glioblastoma multiforme Anaplastic astrocytoma Gliosarcoma Disease in first relapse No primary brainstem or spinal cord gliomas No secondary glioblastomas arising after prior treatment for a non-glial tumor Prior local radiotherapy of 5,000-6,000 cGy required Less than 1.5 cm of residual gadolinium-enhancing tumor in maximal cross-sectional diameter by MRI No metastatic tumor by spinal MRI PATIENT CHARACTERISTICS: Age Under 21 at diagnosis Performance status Lansky 50-100% OR Karnofsky 50-100% Life expectancy Not specified Hematopoietic Absolute neutrophil count ≥ 500/mm^3 Platelet count ≥ 100,000/mm^3 (transfusion independent) Hepatic Bilirubin ≤ 1.5 times upper limit of normal (ULN) AST or ALT < 2.5 times ULN Renal Glomerular filtration rate ≥ 60 mL/min AND/OR Creatinine clearance ≥ 60 mL/min Cardiovascular Shortening fraction ≥ 27% by echocardiogram OR Ejection fraction ≥ 50% by MUGA Pulmonary No dyspnea at rest No exercise intolerance Pulse oximetry > 94% Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy More than 4 weeks since prior chemotherapy No prior thiotepa No prior myeloablative chemotherapy Endocrine therapy No concurrent corticosteroids Radiotherapy See Disease Characteristics More than 8 weeks since prior radiotherapy No prior craniospinal radiotherapy Surgery Not specified
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ziad Khatib, MD
Organizational Affiliation
Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sharon L. Gardner, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Study Chair
Facility Information:
Facility Name
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Children's Hospital and Research Center - Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94609-1809
Country
United States
Facility Name
University of California Davis Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Children's Hospital and Health Center - San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123-4282
Country
United States
Facility Name
Children's Hospital Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218-1088
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010-2970
Country
United States
Facility Name
University of Florida Shands Cancer Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0232
Country
United States
Facility Name
Nemours Children's Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
University of Miami Sylvester Comprehensive Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Miami Children's Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
All Children's Hospital
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
St. Joseph's Cancer Institute at St. Joseph's Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Kaplan Cancer Center at St. Mary's Medical Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Emory University Hospital - Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Cancer Research Center of Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
95813
Country
United States
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5289
Country
United States
Facility Name
St. Vincent Indianapolis Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Kosair Children's Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40232
Country
United States
Facility Name
CancerCare of Maine at Eastern Maine Medial Center
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Floating Hospital for Children at Tufts - New England Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1379
Country
United States
Facility Name
Spectrum Health Cancer Care - Butterworth Campus
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503-2560
Country
United States
Facility Name
Van Elslander Cancer Center at St. John Hospital and Medical Center
City
Grosse Pointe Woods
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Children's Hospital of Minnesota - Minneapolis
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Fairview University Medical Center - University Campus
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216-4505
Country
United States
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Siteman Cancer Center at Barnes-Jewish Hospital
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States
Facility Name
NYU Cancer Institute at New York University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Herbert Irving Comprehensive Cancer Center at Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
James P. Wilmot Cancer Center at University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
SUNY Upstate Medical University Hospital
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Children's Hospital Medical Center of Akron
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308-1062
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3039
Country
United States
Facility Name
Rainbow Babies and Children's Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5000
Country
United States
Facility Name
Columbus Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205-2696
Country
United States
Facility Name
Children's Medical Center - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45404-1815
Country
United States
Facility Name
Oklahoma University Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Penn State Cancer Institute at Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Facility Name
Hollings Cancer Center at Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Sioux Valley Hospital and University of South Dakota Medical Center
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117-5039
Country
United States
Facility Name
Cook Children's Medical Center - Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104-9958
Country
United States
Facility Name
Covenant Children's Hospital
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
Primary Children's Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113-1100
Country
United States
Facility Name
INOVA Fairfax Hospital
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Children's Hospital of the King's Daughters
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507-1971
Country
United States
Facility Name
Massey Cancer Center at Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0037
Country
United States
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-6164
Country
United States
Facility Name
Marshfield Clinic - Marshfield Center
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Princess Margaret Hospital for Children
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6001
Country
Australia
Facility Name
Children's & Women's Hospital of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
Country
Canada
Facility Name
McMaster Children's Hospital at Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Facility Name
Montreal Children's Hospital at McGill University Health Center
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 1P3
Country
Canada
Facility Name
Hopital Sainte Justine
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Quebec
City
Ste-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs