Boron Neutron Capture Therapy, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
|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.|
|ClinicalTrials.gov Identifier: NCT00974987|
Recruitment Status : Active, not recruiting
First Posted : September 11, 2009
Last Update Posted : June 20, 2017
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|
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 :||September 1, 2009|
|Actual Primary Completion Date :||February 28, 2016|
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.
- Overall survival (OS) [ Time Frame: Time to death from BSH injection（up to 6 years） ]
- 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 ]
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
|Osaka Medical College|
|Takatsuki, Osaka, Japan, 569-8686|
|Principal Investigator:||Shin-Ichi Miyatake, MD, PhD||Osaka Medical College|