Dr. Robert G. Zamenhof
Beth Israel Deaconess Medical Center
Department of Radiology
1 Deaconess Road
Boston, MA 02215
Phone: 617-667-0175 Ext: N/A
Fax: 617-975-5233
Email: zamenhof@mit.edu
Projects are approved by an IRB located at: Beth Israel Deaconess Medical Center.
The approving IRB operates under a Multiple Project Assurance (MPA) recognized by DOE or by the Department of Health and Human Services (HHS).
MPA number of the IRB: M-1544
Number of Human Subjects Projects reported: 2
Project Identifier: BIDMC-94-1
Project Title:
Phase-I BNCT Trial of Peripheral Melanoma
Principal Investigator:
Dr. Robert G. Zamenhof
Project started in: 1994
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project did not use human subjects in Fiscal Year 1998.
Explanation:
This is a protocol where accrual is very difficult. Most subjects who would be candidates can be convinced that surgery is a more definitive treatment than experimental BNCT.
Funding Sources:
Total annual grant support: $1.1m. Since there are two clinical protocols under this grant, each has been assigned half of the total, i.e., $0.55m.
Project involves use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 1
Protocol/Subproject # 1
IRB Review:
Type of Review: Full Board
Most Recent Approval: April 01, 1997
IRB Approval Number: 97-1207-015
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 0
Type of Human Subjects Involvement:
OBJECTIVES: To determine the safety and feasibility of boron neutron capture therapy (BNCT) of peripheral melanoma. To identify via a phase-I dose escalation protocol the safety, feasibility, and radiotoxicity of BNCT.
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 concerns.
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 from the administration of the BPA-F.
HUMAN SUBJECT INVOLVEMENT: Subjects with peripheral 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
Project Title:
Phase-I BNCT Trial of Glioblastoma Multiforme and Metastatic Melanoma to the Brain
Principal Investigator:
Dr. Robert G. Zamenhof
Project started in: 1996
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project used human subjects in Fiscal Year 1998.
Funding Sources:
Total annual DOE grant: $1.1m. Since there are two clinical protocols operative under this grant each has arbitrarily been allocated $0.55m.
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: February 02, 1998
IRB Approval Number: 97-1207-014
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 7
Type of Human Subjects Involvement:
OBJECTIVES: To determine the safety and feasibility of boron neutron capture therapy (BNCT) of glioblastoma multiforme and metastatic melanoma to the brain. To identify via a phase-I dose-escalation protocol the radiotoxicity threshold of BNCT to the brain.
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. They then undergo a CT-guided stereotactic biopsy of their tumor. Subjects return for periodic follow-up.
RISKS: Ionizing radiation; administration of BPA-F drug; inherent risk of stereotactic biopsy; infection from needle sticks; inability to receive a full course of conventional radiotherapy following BNCT.