Brain and Central Nervous System Tumors
Conditions
Keywords
adult giant cell glioblastoma, adult glioblastoma, adult gliosarcoma
Brief summary
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.
Detailed description
OBJECTIVES: * 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.
Interventions
RADIATIONBNCT(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.
RADIATIONXRT(X-ray radiation treatment)
After BNCT, 2Gy irradiation every day for 12 days.
DRUGTMZ(temozolomide)
75mg/m2 for day1-12. After XRT, repeat the cycle of 150-200mg/m2 for 5 days and cessation for 23 days.
Sponsors
Department of Nuerosurgery, Osaka Medical College
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed glioblastoma multiforme * Newly diagnosed disease * Tumor located at a supratentorial hemisphere * Deepest part of tumor \< 6 cm from the scalp * Bottom of the tumor \> 6 cm from the scalp allowed provided air instillation into tumor-removed cavity is possible * No cerebrospinal fluid dissemination PATIENT CHARACTERISTICS: * Karnofsky performance status 70-100% * Life expectancy \> 3 months * Leukocyte count ≥ 3,000/μL * Platelet count ≥ 10.0 × 10\^4/μL * Hemoglobin ≥ 8.0 g/dL * Serum creatinine ≤ 1.5 mg/dL * ALT and AST ≤ 100 IU/L * No phenylketonuria * Not pregnant or nursing * No NYHA class III-IV heart failure * No patient whose participation in the present study is considered inappropriate by a Principal Investigator or Clinical Investigator PRIOR CONCURRENT THERAPY: * No prior chemotherapy or radiotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (OS) | Time to death from BSH injection（up to 6 years） |
Secondary
| Measure | Time frame |
|---|---|
| Tumor response（RECIST） | From BSH injection to the end of treatment, whichever came first, assessed up to 96 weeks |
| Objective Response Rate (ORR) | From BSH injection to the end of treatment, whichever came first, assessed up to 96 weeks |
| Disease Control Rate (DCR) | From BSH injection to the end of treatment, whichever came first, assessed up to 96 weeks |
| Adverse event | Time to final follow-up survey from the date of enrollment |
Countries
Japan
Outcome results
None listed