Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00078988
Status:
COMPLETED
Last Update Posted:
2015-05-07
First Post:
2004-03-08
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
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA098543 | NIH | CTRP Clinical Trial Reporting Program | httpsreporternihgovquickSearchU10CA098543 |
| COG-ACNS0231 | OTHER | None | None |
| CDR0000353207 | OTHER | None | None |
| NCI-2012-02578 | REGISTRY | None | None |