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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2009 by National Cancer Institute (NCI). Recruitment status was Recruiting

First Received on September 10, 2009. Last Updated on November 21, 2009 History of Changes

Sponsor:	Osaka Medical College
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00974987

Purpose

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	Intervention	Phase
Brain and Central Nervous System Tumors	Drug: temozolomide Procedure: adjuvant therapy Radiation: boron neutron capture therapy Radiation: radiation therapy	Phase II

Study Type:	Interventional
Study Design:	Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer X-Rays

Drug Information available for: Temozolomide

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

Tumor response [ Designated as safety issue: No ]
Adverse effects [ Designated as safety issue: Yes ]

Estimated Enrollment:	45
Study Start Date:	September 2009
Estimated Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:	15 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00974987

Locations

Japan
Osaka Medical College	Recruiting
Takatsuki, Osaka, Japan, 569-8686
Contact: Shin-Ichi Miyatake, MD, PhD 81-72-683-1221

Sponsors and Collaborators

Osaka Medical College

Investigators

Principal Investigator:

Shin-Ichi Miyatake, MD, PhD

Osaka Medical College

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00974987 History of Changes
Other Study ID Numbers:	CDR0000650829, OSAKA-TRIBRAIN0902
Study First Received:	September 10, 2009
Last Updated:	November 21, 2009
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

adult giant cell glioblastoma
adult glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:

Glioblastoma
Nervous System Neoplasms
Central Nervous System Neoplasms
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site

Nervous System Diseases
Boron
Temozolomide
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012