USDOE Human Subjects Research Database, fiscal year 1995

Brookhaven National Laboratory

Project Identifier: BNL-95-260

Project Title:

Boron Neutron Capture Therapy of Glioblastoma Multiforme at the Brookhaven Medical Research Reactor (BMRR)

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: $739,000 (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: January 04, 1995

Number of Human Subjects in the Last Reporting Period for this Project: 12
(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])

We propose to determine a safe starting dose for Boron Neutron Capture Therapy (BNCT), evaluate any adverse effects of BNCT and evaluate the effectiveness of BNCT in patients with glioblastoma multiforme. Irradiation will be carried out at the epithermal beam of the Brookhaven Medical Research Reactor (BMRR) following an intravenous infusion of p-boronophenylalanine-fructose (BPA-F). We propose to study 14 patients at three to four weeks following BPA biodistribution at first craniotomy for tumor debulking and 14 patients at three to four weeks following BPA biodistribution at second craniotomy for tumor debulking. No repeat studies are proposed in this protocol.

During the BNCT procedures at the epithermal neutron beam of the BMRR, the patients will be 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. They receive up to 370 milligrams per kilogram (mg/kg) of the amino acid analog boronophenylalanine intravenously in conjunction with debulking craniotomy and/or in conjunction with the BNCT procedure. For the biodistribution phase of the study, the 10-BPA-F complexed in the fructose is infused intravenously for 1 to 2 hours prior to the surgical debulking of the tumor. Samples of the tumor, including normal brain tissue if any, are analyzed for 10-B content. For the BNCT phase, 10-BPA-F is injected intravenously for 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.