Skip to main content
OpenTrials
Completed

NCT Number: NCT00974987

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Brain and Central Nervous System Tumors Astrocytoma Central Nervous System Neoplasms Glioblastoma Glioma Gliosarcoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors

Age range

15 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Osaka Medical College

Takatsuki, Osaka, 569-8686, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Overall survival (OS)

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

Secondary outcomes

  1. Tumor response（RECIST）

    Time frame: From BSH injection to the end of treatment, whichever came first, assessed up to 96 weeks

  2. Objective Response Rate (ORR)

    Time frame: From BSH injection to the end of treatment, whichever came first, assessed up to 96 weeks

  3. Disease Control Rate (DCR)

    Time frame: From BSH injection to the end of treatment, whichever came first, assessed up to 96 weeks

  4. Adverse event

    Time frame: Time to final follow-up survey from the date of enrollment

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Department of Nuerosurgery, Osaka Medical College

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2016
Study completion
2016
First posted
Sep 11, 2009
Registry last updated
Apr 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.