Boron Neutron Capture Therapy, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan32 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Brain and Central Nervous System Tumors

BNCT(boron neutron capture therapy)RADIATION

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.

XRT(X-ray radiation treatment)RADIATION

After BNCT, 2Gy irradiation every day for 12 days.

TMZ(temozolomide)DRUG

75mg/m2 for day1-12. After XRT, repeat the cycle of 150-200mg/m2 for 5 days and cessation for 23 days.

Eligibility

Sex: ALLMin age: 15 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Overall survival (OS)

Time frame: Time to death from BSH injection（up to 6 years）

Secondary Outcomes

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

Boron Neutron Capture Therapy, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes