A Phase II Study Of Radiation Therapy Plus Low Dose Temozolomide Followed By Temozolomide Plus Irinotecan For Glioblastoma Multiforme
A Phase II Study Of Radiation Therapy Plus Low Dose Temozolomide Followed By Temozolomide Plus Irinotecan For Glioblastoma Multiforme
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as temozolomide and irinotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well radiation therapy, temozolomide, and irinotecan work in treating patients with newly diagnosed glioblastoma multiforme.
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients are followed every 2 months for 2 years and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 157 patients will be accrued for this study within 11 months.
DISEASE CHARACTERISTICS:
Histologically confirmed newly diagnosed supratentorial glioblastoma multiforme by surgical biopsy or excision
No tumor foci below the tentorium or beyond the cranial vault
Study therapy must begin ≤ 5 weeks after surgery
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
No prior radiotherapy to the head or neck resulting in overlap of radiotherapy fields
Surgery
Other
No enzyme-inducing antiepileptic drugs within 14 days before the initiation of irinotecan
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