Clinical trial NCT00974987: Boron Neutron Capture Therapy, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Official title: A Phase II, Multicenter, Study for Newly Diagnosed Glioblastomas Using Boron Neutron Capture Therapy, Additional X-ray Treatment and Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Brain and Central Nervous System Tumors
Keywords: adult giant cell glioblastoma
adult glioblastoma
adult gliosarcoma
Lead sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Sponsor class: OTHER
Collaborators: name: Department of Nuerosurgery, Osaka Medical College
First posted: 2009-09-11
Enrollment: 32
Sex: ALL
Minimum age (years): 15
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Overall survival (OS)
timeFrame: Time to death from BSH injection（up to 6 years）
Secondary outcomes:
measure: Tumor response（RECIST）
timeFrame: From BSH injection to the end of treatment, whichever came first, assessed up to 96 weeks
measure: Objective Response Rate (ORR)
timeFrame: From BSH injection to the end of treatment, whichever came first, assessed up to 96 weeks
measure: Disease Control Rate (DCR)
timeFrame: From BSH injection to the end of treatment, whichever came first, assessed up to 96 weeks
measure: Adverse event
timeFrame: Time to final follow-up survey from the date of enrollment
Other outcomes:
Locations:
city: Takatsuki
country: Japan
facility: Osaka Medical College
state: Osaka
Study officials:
affiliation: Osaka Medical College
name: Shin-Ichi Miyatake, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.