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

NCT ID: NCT00974987

Last Updated: 2018-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-01
• Study Completion Date: 2016-02-29

Brief 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.

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.

Conditions

Brain and Central Nervous System Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group

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

Group Type: EXPERIMENTAL

BNCT(boron neutron capture therapy)

Intervention Type: 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)

Intervention Type: RADIATION

After BNCT, 2Gy irradiation every day for 12 days.

TMZ(temozolomide)

Intervention Type: DRUG

75mg/m2 for day1-12. After XRT, repeat the cycle of 150-200mg/m2 for 5 days and cessation for 23 days.

Interventions

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.

Intervention Type: RADIATION

XRT(X-ray radiation treatment)

After BNCT, 2Gy irradiation every day for 12 days.

Intervention Type: RADIATION

TMZ(temozolomide)

75mg/m2 for day1-12. After XRT, repeat the cycle of 150-200mg/m2 for 5 days and cessation for 23 days.

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Department of Nuerosurgery, Osaka Medical College

UNKNOWN

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shin-Ichi Miyatake, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Osaka Medical College

Locations

Osaka Medical College

Takatsuki, Osaka, Japan

Countries

Japan

References

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 diagnosed glioblastoma multiforme--study design and current status report. Appl Radiat Isot. 2011 Dec;69(12):1796-9. doi: 10.1016/j.apradiso.2011.03.014. Epub 2011 Mar 21.

Reference Type: RESULT

PMID: 21459588 (View on PubMed)

Other Identifiers

CDR0000650829

Identifier Type: REGISTRY

Identifier Source: secondary_id

UMIN000002385

Identifier Type: REGISTRY

Identifier Source: secondary_id

OSAKA-TRIBRAIN0902

Identifier Type: -

Identifier Source: org_study_id