Brain Tumors Clinical Trial
Official title:
Treatment of Children With Diffuse Intrinsic Brain Stem Glioma With Standard Dose Irradiation and Vincristine Plus Oral VP-16, A POG Pilot Study
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor
cells. Combining more than one drug with radiation therapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of vincristine plus etoposide and
radiation therapy in treating children who have newly diagnosed brain stem glioma.
OBJECTIVES: I. Evaluate the efficacy of vincristine plus etoposide with concurrent
radiotherapy on one year survival in children with newly diagnosed diffuse intrinsic brain
stem glioma. II. Assess the toxicity of this regimen in this patient population.
OUTLINE: Induction: Patients receive oral etoposide daily on days 1-21 and vincristine IV on
days 1, 8, and 15. Treatment repeats every 4 weeks for 2 courses. Patients receive
radiotherapy daily for 6 weeks concurrently with induction chemotherapy. Maintenance: One
week after induction therapy, patients receive vincristine IV on days 1 and 8 and oral
etoposide daily on days 1-21. Treatment repeats every 4 weeks for 10 courses in the absence
of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2
years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 2 years.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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