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

Brain and Central Nervous System Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00974987
• Other study ID #: OSAKA-TRIBRAIN0902
• Secondary ID: CDR0000650829UMI
• Status: Completed
• Phase: Phase 2
• First received: September 10, 2009
• Last updated: April 24, 2018
• Start date: September 1, 2009
• Est. completion date: February 29, 2016

Study information

• Verified date: June 2017
• Source: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 29, 2016
• Est. primary completion date: February 29, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Glioblastoma
• Nervous System Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
Japan	Osaka Medical College	Takatsuki	Osaka

Sponsors (2)

Lead Sponsor	Collaborator
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan	Department of Nuerosurgery, Osaka Medical College

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Kawabata S, Miyatake S, Hiramatsu R, Hirota Y, Miyata S, Takekita Y, Kuroiwa T, Kirihata M, Sakurai Y, Maruhashi A, Ono K. Phase II clinical study of boron neutron capture therapy combined with X-ray radiotherapy/temozolomide in patients with newly diagno — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS)		Time to death from BSH injection(up to 6 years)
Secondary	Tumor response(RECIST)		From BSH injection to the end of treatment, whichever came first, assessed up to 96 weeks
Secondary	Objective Response Rate (ORR)		From BSH injection to the end of treatment, whichever came first, assessed up to 96 weeks
Secondary	Disease Control Rate (DCR)		From BSH injection to the end of treatment, whichever came first, assessed up to 96 weeks
Secondary	Adverse event		Time to final follow-up survey from the date of enrollment