USDOE Human Subjects Research Database, fiscal year 1995

Brookhaven National Laboratory

Project Identifier: BNL-89-C13

Project Title:

Biodistribution of p-Boronophenylalanine in Patients with Malignant Melanoma and Malignant Brain Tumors

Principle Investigator: Dr. Jeffrey A. Coderre

Project started in: 1989

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: $180,000 (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: April 05, 1995

Number of Human Subjects in the Last Reporting Period for this Project: 6
(Reporting periods vary.)

Type of Human Subjects Involvement:

Chemical Substances:

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

• For diagnostic 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 boron-containing amino acid p-boronophenylalanine (BPA) is used as the boron-delivery agent for an experimental radiotherapy known as boron neutron capture therapy (BNCT). BPA-based BNCT has been shown to be effective in treating several types of tumors carried in laboratory animals. The key to effective BNCT is the selective delivery of boron to the tumor. The Phase I biodistribution study of BPA in human cancer patients has two objectives: 1) to establish the safety and degree of toxicity of BPA administered intravenously (i.v.); and 2) to measure the amount of boron accumulated in human tumors. Patients with melanoma, glioblastoma or breast cancer, already scheduled for surgery, are given BPA. Serial blood and urine samples are collected as well as tumor (and normal tissue, if available) samples at the time of the surgery. The number of subjects per year will be approximately 10-20. There will be no repeat studies.

Aside from hypersensitivity, there are no known risks to the patients from BPA.