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

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Status and phase: Completed; Phase 2

Conditions: Brain and Central Nervous System Tumors

Treatments: Radiation: XRT(X-ray radiation treatment); Drug: TMZ(temozolomide); Radiation: BNCT(boron neutron capture therapy)

Study type: Interventional

Funder types: Other

Identifiers

NCT00974987

OSAKA-TRIBRAIN0902

CDR0000650829 (Registry Identifier)

UMIN000002385 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 15 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Treatment group

Experimental group

Description:

BNCT(boron neutron capture therapy), XRT(X-ray radiation treatment) and TMZ(temozolomide) treatment

Treatment:

Radiation: XRT(X-ray radiation treatment)

Drug: TMZ(temozolomide)

Radiation: BNCT(boron neutron capture therapy)