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

April 24, 2018 updated by: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Osaka
      • Takatsuki, Osaka, Japan, 569-8686
        • Osaka Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Tumor response（RECIST）
Time Frame: From BSH injection to the end of treatment, whichever came first, assessed up to 96 weeks
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
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
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
Time to final follow-up survey from the date of enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Department of Nuerosurgery, Osaka Medical College

Investigators

  • Principal Investigator: Shin-Ichi Miyatake, MD, PhD, Osaka Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2009

Primary Completion (Actual)

February 29, 2016

Study Completion (Actual)

February 29, 2016

Study Registration Dates

First Submitted

September 10, 2009

First Submitted That Met QC Criteria

September 10, 2009

First Posted (Estimate)

September 11, 2009

Study Record Updates

Last Update Posted (Actual)

April 25, 2018

Last Update Submitted That Met QC Criteria

April 24, 2018

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSAKA-TRIBRAIN0902
  • CDR0000650829 (Registry Identifier: PDQ (Physician Data Query))
  • UMIN000002385 (Registry Identifier: UMIN CTR)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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