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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase II, Multicenter, Study for Newly Diagnosed Glioblastomas Using Boron Neutron Capture Therapy, Additional X-ray Treatment and Chemotherapy

Conditions
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Brain and Central Nervous System Tumors

Intervention / Treatment
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* Radiation: BNCT(boron neutron capture therapy)
* Radiation: XRT(X-ray radiation treatment)
* Drug: TMZ(temozolomide)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>BNCT(boron neutron capture therapy), XRT(X-ray radiation treatment) and TMZ(temozolomide) treatment | Radiation: BNCT(boron neutron capture therapy)<br>* 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.<br>Radiation: XRT(X-ray radiation treatment)<br>* After BNCT, 2Gy irradiation every day for 12 days.<br>Drug: TMZ(temozolomide)<br>* 75mg/m2 for day1-12. After XRT, repeat the cycle of 150-200mg/m2 for 5 days and cessation for 23 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) |  | Time to death from BSH injection（up to 6 years） | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adult giant cell glioblastoma, adult glioblastoma, adult gliosarcoma