Brain Tumor Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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