USDOE Human Subjects Research Database, fiscal year 1995

Brookhaven National Laboratory

Project Identifier: BNL-95-260A

Project Title:

Boron Neutron Capture Therapy (BNCT) of Glioblastoma Multiforme at the BMRR (Prior Radiation)

Principle Investigator: Dr. Arjun D. Chanana

Project started in: 1995

Fiscal Year 1995 Funding for Research on Human Subjects:

Project Funding Information:
Project received funding in Fiscal Year 1995.
Project used human subjects in Fiscal Year 1995.

Funding Sources:

DOE: Office of Health and Environmental Research (OHER)

Amount: $155,000 (Est.)

Information on Use of Human Subjects:

Project does not involve use of multiple protocols/subprojects.

IRB Review:
Type of Review: Full Board
Most Recent Approval: May 26, 1995

Number of Human Subjects in the Last Reporting Period for this Project: 2
(Reporting periods vary.)

Type of Human Subjects Involvement:

Ionizing Radiation and Radioactive Substances:

External use of ionizing radiation on human subjects.

• For therapeutic research.

Chemical Substances:

Internal use of chemical substances (solid, liquid, or gas) in human subjects.

• For therapeutic research.

Collection of Bodily Materials:

Collection of personally identifiable bodily materials (blood or blood products, cells, tissue, organs, waste).

• Use of bodily materials collected from subjects specifically for this project.

(a. Objectives, b. Methodology, c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which human subjects are exposed, d. Involvement of Human Subjects [d.1. procedures used, d.2. risks if any])

The objective of this study is to evaluate the safety of a marginally higher and conceivably more hazardous dose of radiation in the normal brain than is tested under the companion protocol (BNL-95-260). A total of five patients with glioblastoma multiforme will be studied using BNCT following a two hour intravenous infusion of p-boronophenylalanine-fructose (10-BPA-F) at a dose of up to 370 milligrams (mg) 10-BPA per kilogram (kg). The peak dose to normal brain shall be ~12.6 Gray equivalent (Gy-Eq) delivered at a dose rate of approximately 27 centigray equivalent per minute (cGy-Eq/min). The deepest contrast enhanced tumor margin shall be between 6 centimeters (cm) and 6.8 cm from the scalp surface and the patient will have received no more than 500 cGy of brain irradiation. The biodistribution phase may be dispensed with for those patients who have had more than one craniotomy or whose contrast enhanced computed tomography (CT) and/or magnetic resonance imaging (MRI) scans show no residual tumor at the time of referral for BNCT. Repeat BNCT shall not be performed under this protocol. During the BNCT procedure at the epithermal neutron beam of the Brookhaven Medical Research Reactor (BMRR), the patients are exposed to the heavy charged particles (gamma, 7-Li) resulting from the capture of slow "thermal" neutrons by 10-B nuclei and to protons and gamma photons. The patients receive up to 370 mg/kg of 10-BPA-F intravenously in conjunction with debulking craniotomy and/or in conjunction with the BNCT procedure. For the biodistribution phase of the study, 10-BPA-F is infused intravenously for 1-2 hours prior to the surgical debulking of the tumor. Samples of the tumor including normal brain tumor if any and blood are analyzed for 10-B content. For the BNCT phase of the study, 10-BPA is injected intravenously over 1-2 hours. Approximately 1 hour following the completion of the infusion, the patient's head is exposed to the epithermal neutron beam. Complications may include nausea, vomiting, brain swelling, headaches, muscular weakness, loss of coordination, somnolence, seizures, stupor, memory loss, hearing loss, impaired speech, alopecia, ulceration and necrosis of scalp, cataracts, blindness, skull bone necrosis, loss of bodily functions due to brain damage, coma, or death.