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
NCT ID: NCT00078988
Last Updated: 2015-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1 participants
INTERVENTIONAL
2004-10-31
2006-09-30
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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 SC once daily beginning on day 1 and continuing until blood counts recover. Autologous PBSC or bone marrow are reinfused on day 0.
filgrastim
Given IV
carboplatin
Given IV
etoposide
Given IV
isotretinoin
Given IV
thiotepa
Given IV
autologous bone marrow transplantation
Peripheral blood stem cells or bone marrow will be reinfused about 72 hours following completion of the last dose of chemotherapy (Day 0)
peripheral blood stem cell transplantation
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.
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.
filgrastim
Given IV
carboplatin
Given IV
thiotepa
Given IV
autologous bone marrow transplantation
Peripheral blood stem cells or bone marrow will be reinfused about 72 hours following completion of the last dose of chemotherapy (Day 0)
peripheral blood stem cell transplantation
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.
Arm III (isotretinoin)
Patients receive oral isotretinoin twice daily on days 1-14. Treatment repeats every 28 days for a total of 6 courses.
isotretinoin
Given IV
Arm IV (no isotretinoin)
Patients do not receive maintenance therapy.
No interventions assigned to this group
Interventions
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filgrastim
Given IV
carboplatin
Given IV
etoposide
Given IV
isotretinoin
Given IV
thiotepa
Given IV
autologous bone marrow transplantation
Peripheral blood stem cells or bone marrow will be reinfused about 72 hours following completion of the last dose of chemotherapy (Day 0)
peripheral blood stem cell transplantation
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
20 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Ziad Khatib, MD
Role: STUDY_CHAIR
Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Sharon L. Gardner, MD
Role: STUDY_CHAIR
NYU Langone Health
Locations
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Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Children's Hospital and Research Center - Oakland
Oakland, California, United States
University of California Davis Cancer Center
Sacramento, California, United States
Children's Hospital and Health Center - San Diego
San Diego, California, United States
Children's Hospital Cancer Center
Denver, Colorado, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
University of Florida Shands Cancer Center
Gainesville, Florida, United States
Nemours Children's Clinic
Jacksonville, Florida, United States
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Miami Children's Hospital
Miami, Florida, United States
All Children's Hospital
St. Petersburg, Florida, United States
St. Joseph's Cancer Institute at St. Joseph's Hospital
Tampa, Florida, United States
Kaplan Cancer Center at St. Mary's Medical Center
West Palm Beach, Florida, United States
Emory University Hospital - Atlanta
Atlanta, Georgia, United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
St. Vincent Indianapolis Hospital
Indianapolis, Indiana, United States
Kosair Children's Hospital
Louisville, Kentucky, United States
CancerCare of Maine at Eastern Maine Medial Center
Bangor, Maine, United States
Floating Hospital for Children at Tufts - New England Medical Center
Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Spectrum Health Cancer Care - Butterworth Campus
Grand Rapids, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States
Children's Hospital of Minnesota - Minneapolis
Minneapolis, Minnesota, United States
Fairview University Medical Center - University Campus
Minneapolis, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
NYU Cancer Institute at New York University Medical Center
New York, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States
SUNY Upstate Medical University Hospital
Syracuse, New York, United States
New York Medical College
Valhalla, New York, United States
Children's Hospital Medical Center of Akron
Akron, Ohio, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States
Columbus Children's Hospital
Columbus, Ohio, United States
Children's Medical Center - Dayton
Dayton, Ohio, United States
Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls, South Dakota, United States
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, United States
Covenant Children's Hospital
Lubbock, Texas, United States
Primary Children's Medical Center
Salt Lake City, Utah, United States
INOVA Fairfax Hospital
Fairfax, Virginia, United States
Children's Hospital of the King's Daughters
Norfolk, Virginia, United States
Massey Cancer Center at Virginia Commonwealth University
Richmond, Virginia, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States
Princess Margaret Hospital for Children
Perth, Western Australia, Australia
Children's & Women's Hospital of British Columbia
Vancouver, British Columbia, Canada
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, Canada
Hospital for Sick Children
Toronto, Ontario, Canada
Montreal Children's Hospital at McGill University Health Center
Montreal, Quebec, Canada
Hopital Sainte Justine
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec
Ste-Foy, Quebec, Canada
Countries
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Other Identifiers
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COG-ACNS0231
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000353207
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2012-02578
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACNS0231
Identifier Type: -
Identifier Source: org_study_id
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