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

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 15 Years - 75 Years
Gender All
More Inclusion & 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00974987
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

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

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Shin-Ichi Miyatake, MD, PhD
Principal Investigator Affiliation Osaka Medical College
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Completed
Countries Japan
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Brain and Central Nervous System Tumors
Additional Details

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.

Arms & Interventions

Arms

Experimental: Treatment group

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

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Osaka Medical College, Takatsuki, Osaka, Japan

Status

Address

Osaka Medical College

Takatsuki, Osaka, 569-8686

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