USDOE Human Subjects Research Database, Fiscal Year 1999

Beth Israel Deaconess Medical Center

Public Information Contact:

Dr. Paul M. Busse
Beth Israel Deaconess Medical Center
Department of Radiation Oncology
Meisner-B
Boston, MA 02215-

Phone: 617-632-8510
Fax: 617-632-0339
E-mail: busse@jcrt.harvard.edu

Institutional Review Board (IRB):

Human Subject Projects:

Number of Human Subjects projects reported: 2

BIDMC-94-1

"Phase-I BNCT Trial of Peripheral Melanoma"

BIDMC-96-2

"Phase-I BNCT Trial of Glioblastoma Multiforme and Metastatic Melanoma to the Brain"

Project Identifier: BIDMC-94-1

"Phase-I BNCT Trial of Peripheral Melanoma"

Principal Investigator: Dr. Paul M. Busse, Beth Israel Deaconess Medical Center

Project started in: 1994

Project Funding Information:

Funding for Human Subjects Research:

DOE: Office of Biological and Environmental Research (OBER)

$100,000.00 (Est.) for: Fiscal Year 1999
Total annual grant support: $1.55m. Since there are two clinical protocols under this grant and a basic research program, this project has been assigned a funding amount of $100,000.

Information on Use of Human Subjects:

This project does not involve the use of multiple protocols/subprojects.

Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 03/01/99
IRB approval number: 97-1207-015

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects: Fiscal Year 1999 (10/1/98-9/30/99)

Type(s) of Human Subjects Involvement:

External use of ionizing radiation on human subjects:

• For therapeutic research

Internal use of chemical substances (solid, liquid, or gas) on human subjects:

• For therapeutic research

Collection of personally identifiable bodily materials (blood or blood products, urine, cells, tissue, teeth, organs, excretia, etc):

• Using bodily materials collected specifically for this project.

Use of personally identifiable data from questionnaires, surveys, or epidemiological studies:

• Using data collected from subjects specifically for this project.

Other types of human subjects involvement. Explanation:

Experimental dose-escalation phase-I radiotherapy trial for peripheral melanoma

(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])

OBJECTIVES: To determine the safety and feasibility of boron neutron capture therapy (BNCT) for peripheral melanoma via a phase-I dose escalation protocol.

METHODOLOGY: BNCT is implemented using boronophenylalanine-fructose (BPA-F) and epithermal neutrons. Peripheral sites were chosen for initial irradiation prior to the central nervous system based on safety issues and the availability of a clearly evaluable tissue site with the possibility of unirradiated control lesions which could also be biopsied.

IONIZING RADIATION AND DRUG TOXICITY: Subjects are exposed to controlled doses of high-LET (linear energy transfer) ionizing radiation in the BNCT procedure and to potential drug toxicity from the administration of the BPA-F.

HUMAN SUBJECT INVOLVEMENT: Subjects with peripheral melanoma lesions receive a treatment planning CT scan, baseline electrocardiogram, vital signs tests, blood and electrolyte tests, hepatic function tests, and a chest X-ray. BPA-F is administered intravenously to the subjects and punch biopsies of tumor and normal skin are done. Epithermal neutron irradiation is then delivered to the peripheral melanoma lesion(s). Subjects return for periodic follow-up exams.

RISKS: Ionizing radiation; BPA-F drug toxicity; infection from biopsies and needle sticks; not being able to subsequently receive a full dose of conventional radiation to the irradiated site.

Project Identifier: BIDMC-96-2

"Phase-I BNCT Trial of Glioblastoma Multiforme and Metastatic Melanoma to the Brain"

Principal Investigator: Dr. Paul M. Busse, Beth Israel Deaconess Medical Center

Project started in: 1996

Project Funding Information:

Funding for Human Subjects Research:

DOE: Office of Biological and Environmental Research (OBER)

$1,540,000.00 (Est.) for: Fiscal Year 1999
The total annual DOE grant during the reporting period is $1,550,000.00. There are two clinical protocols operative under this grant: this one (#2) and #1 which has had zero accrual since 1996 and has, therefore, been allocated an estimated funding amount of 100,000.

Information on Use of Human Subjects:

This project does not involve the use of multiple protocols/subprojects.

Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 03/01/99
IRB approval number: 97-1207-014

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 5
Reporting period for number of human subjects: Fiscal Year 1999 (10/1/98-9/30/99)

Type(s) of Human Subjects Involvement:

External use of ionizing radiation on human subjects:

• For clinical research
• For therapeutic research

Internal use of chemical substances (solid, liquid, or gas) on human subjects:

• For clinical research
• For therapeutic research

Collection of personally identifiable bodily materials (blood or blood products, urine, cells, tissue, teeth, organs, excretia, etc):

• Using bodily materials collected specifically for this project.

Use of personally identifiable data from questionnaires, surveys, or epidemiological studies:

• Using data collected from subjects specifically for this project.

Other types of human subjects involvement. Explanation:

Experimental use of BNCT in a phase-I trial

(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])

OBJECTIVES: To determine the safety and feasibility of boron neutron capture therapy (BNCT) of glioblastoma multiforme and metastatic melanoma to the brain via a phase-I dose-escalation protocol.

METHODOLOGY: BNCT is implemented using intravenously administered boronophenylalanine-fructose (BPA-F) and epithermal neutron irradiation.

IONIZING RADIATION AND DRUG TOXICITY: Subjects are exposed to controlled doses of high-LET (linear energy transfer) ionizing radiation by the BNCT procedure and to potential drug toxicity by administration of the BPA-F drug.

HUMAN SUBJECT INVOLVEMENT: Subjects with intracranial lesions receive a treatment planning CT scan, blood and electrolyte tests, baseline electrocardiogram, vital signs tests, hepatic function studies, and a chest X-ray. They receive an intravenous dose of boronophenylalanine-fructose (BPA) followed by epithermal neutron irradiation of the brain. Subjects then undergo periodic follow-up.

RISKS: Ionizing radiation; administration of BPA-F drug; infection from needle sticks; inability to receive a full course of conventional radiotherapy following BNCT.