Boron Neutron Capture Therapy, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
RATIONALE: Boron neutron capture therapy and radiation therapy use high-energy x-rays and other types of radiation to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving boron neutron capture therapy followed by radiation therapy and temozolomide may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects of giving boron neutron capture therapy together with radiation therapy and temozolomide in treating patients with newly diagnosed glioblastoma multiforme.
|Brain and Central Nervous System Tumors||Radiation: BNCT(boron neutron capture therapy) Radiation: XRT(X-ray radiation treatment) Drug: TMZ(temozolomide)||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase II, Multicenter, Study for Newly Diagnosed Glioblastomas Using Boron Neutron Capture Therapy, Additional X-ray Treatment and Chemotherapy|
- Overall survival (OS) [ Time Frame: Time to death from BSH injection（up to 6 years） ]
- Tumor response（RECIST） [ Time Frame: From BSH injection to the end of treatment, whichever came first, assessed up to 96 weeks ]
- Objective Response Rate (ORR) [ Time Frame: From BSH injection to the end of treatment, whichever came first, assessed up to 96 weeks ]
- Disease Control Rate (DCR) [ Time Frame: From BSH injection to the end of treatment, whichever came first, assessed up to 96 weeks ]
- Adverse event [ Time Frame: Time to final follow-up survey from the date of enrollment ]
|Actual Study Start Date:||September 1, 2009|
|Primary Completion Date:||February 28, 2016 (Final data collection date for primary outcome measure)|
Experimental: Treatment group
BNCT(boron neutron capture therapy), XRT(X-ray radiation treatment) and TMZ(temozolomide) treatment
Radiation: BNCT(boron neutron capture therapy)
BSH(sodium borocaptate) 100mg/kg iv for one hour starting 13 hours before irradiation, and BPA(p-boronophenylalanine) 500/mg/kg iv at a speed of 200mg/kg/hr for 2 hours starting 2 hours before irradiation. During irradiation, BPA iv continues at a speed of 100mg/kg/hr.Radiation: XRT(X-ray radiation treatment)
After BNCT, 2Gy irradiation every day for 12 days.Drug: TMZ(temozolomide)
75mg/m2 for day1-12. After XRT, repeat the cycle of 150-200mg/m2 for 5 days and cessation for 23 days.
- Evaluate the overall survival of patients with newly diagnosed glioblastoma multiforme treated with boron neutron capture therapy, radiotherapy, and concurrent and adjuvant temozolomide.
- Evaluate tumor response in patients treated with this regimen.
- Evaluate the adverse effects of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients undergo boron neutron capture therapy followed by radiotherapy and concurrent and adjuvant oral temozolomide.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00974987
|Osaka Medical College|
|Takatsuki, Osaka, Japan, 569-8686|
|Principal Investigator:||Shin-Ichi Miyatake, MD, PhD||Osaka Medical College|