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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00974987
First Posted: September 11, 2009
Last Update Posted: June 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Department of Nuerosurgery, Osaka Medical College
Information provided by (Responsible Party):
Translational Research Informatics Center, Kobe, Hyogo, Japan
  Purpose

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.


Condition Intervention Phase
Brain and Central Nervous System Tumors Radiation: BNCT(boron neutron capture therapy) Radiation: XRT(X-ray radiation treatment) Drug: TMZ(temozolomide) Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Multicenter, Study for Newly Diagnosed Glioblastomas Using Boron Neutron Capture Therapy, Additional X-ray Treatment and Chemotherapy

Resource links provided by NLM:


Further study details as provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:

Primary Outcome Measures:
  • Overall survival (OS) [ Time Frame: Time to death from BSH injection(up to 6 years) ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 32
Actual Study Start Date: September 1, 2009
Primary Completion Date: February 28, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00974987


Locations
Japan
Osaka Medical College
Takatsuki, Osaka, Japan, 569-8686
Sponsors and Collaborators
Translational Research Informatics Center, Kobe, Hyogo, Japan
Department of Nuerosurgery, Osaka Medical College
Investigators
Principal Investigator: Shin-Ichi Miyatake, MD, PhD Osaka Medical College
  More Information

Publications:
Responsible Party: Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier: NCT00974987     History of Changes
Other Study ID Numbers: OSAKA-TRIBRAIN0902
CDR0000650829 ( Registry Identifier: PDQ (Physician Data Query) )
UMIN000002385 ( Registry Identifier: UMIN CTR )
First Submitted: September 10, 2009
First Posted: September 11, 2009
Last Update Posted: June 20, 2017
Last Verified: June 2017

Keywords provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:
adult giant cell glioblastoma
adult glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:
Glioblastoma
Nervous System Neoplasms
Central Nervous System Neoplasms
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Temozolomide
Dacarbazine
Boron
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs