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

• Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan (Other)
• Overall Status: Completed
• CT.gov ID: NCT00974987
• Collaborator: Department of Nuerosurgery, Osaka Medical College (Other)
• Enrollment: 32
• Location: 1
• Arm: 1
• Actual Duration (Months): 77.9
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

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

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 Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: N/A
• 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
• Actual Study Start Date: Sep 1, 2009
• Actual Primary Completion Date: Feb 29, 2016
• Actual Study Completion Date: Feb 29, 2016

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Overall survival (OS) [Time to death from BSH injection（up to 6 years）]

Secondary Outcome Measures

1. Tumor response（RECIST） [From BSH injection to the end of treatment, whichever came first, assessed up to 96 weeks]

2. Objective Response Rate (ORR) [From BSH injection to the end of treatment, whichever came first, assessed up to 96 weeks]

3. Disease Control Rate (DCR) [From BSH injection to the end of treatment, whichever came first, assessed up to 96 weeks]

4. Adverse event [Time to final follow-up survey from the date of enrollment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Osaka Medical College	Takatsuki	Osaka	Japan	569-8686

Sponsors and Collaborators

• Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
• Department of Nuerosurgery, Osaka Medical College

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
• ClinicalTrials.gov Identifier: NCT00974987
• Other Study ID Numbers: OSAKA-TRIBRAIN0902; CDR0000650829; UMIN000002385
• First Posted: Sep 11, 2009
• Last Update Posted: Apr 25, 2018
• Last Verified: Jun 1, 2017

• Keywords provided by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan: adult giant cell glioblastoma; adult glioblastoma; adult gliosarcoma
• Additional relevant MeSH terms: Glioblastoma; Nervous System Neoplasms; Central Nervous System Neoplasms; Temozolomide

Study Results

No Results Posted as of Apr 25, 2018