Dr. Robert G. Zamenhof
New England Medical Center
750 Washington Street
Boston, MA 02146
Phone: 617-636-8006 Ext: N/A
Fax: 617-636-8008
Email: robert.zamenhof@es.nemc.org
Projects are approved by an IRB located at: New England 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-1440
Number of Human Subjects Projects reported: 1
Project Identifier: NEMC-87-DEFG0287ER6060
Project Title:
Continuation of Research Program in Neutron Capture Therapy at New England Medical Center and Massachusetts Institute of Technology (formerly Neutron Capture Therapy for Glioblastoma Multiforme)
Principle Investigator:
Dr. Robert G. Zamenhof
Project started in: 1987
Project Funding Information:
Project received funding in Fiscal Year 1995.
Project used human subjects in Fiscal Year 1995.
Funding Sources:
Project involves use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 4
Protocol/Subproject # 1
Protocol/Subproject Identifier: 46,176 / #1
IRB Review:
Type of Review: Full Board
Most Recent Approval: September 19, 1995
IRB Approval Number: 2332
Number of Human Subjects in the Last Reporting Period for this Project: 4
(Reporting periods vary.)
Type of Human Subjects Involvement:
OBJECTIVES: To determine the safety and feasibility of boron neutron capture therapy (BNCT) of peripheral melanoma and intracranial melanoma metastases and glioblastoma. To identify via a phase-1 dose-escalation protocol the radiotoxicity threshold of BNCT.
METHODOLOGY: BNCT implemented using boronated phenylalanine (BPA) and epithermal neutrons from the Massachusetts Institute of Technology (MIT) Research Reactor. Peripheral sites have been irradiated prior to irradiating the central nervous system (CNS) for subject safety reasons.
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 drug.
HUMAN SUBJECT INVOLVEMENT: Subjects with distal lesions receive a computer aided tomography (CT) scan for treatment planning purposes, a baseline electrocardiogram (EKG), vital signs tests, hepatic function studies, a chest x-ray, and blood and electrolyte studies. A test dose of BPA for pharmacokinetic and distribution studies is administered orally to the subject. Subjects then receive an additional oral dose of BPA followed by irradiation of the tumor site with epithermal neutrons from the (MIT) Research Reactor. This is repeated for four "fractions" (sessions separated by 1 or 2 days). Subjects then return at periodic intervals for followup examinations.
RISKS: Ionizing radiation risk, BPA drug toxicity, risks of infection from needle sticks and biopsy procedures, risks of the BNCT radiation burden precluding full delivery of a subsequent conventional course of radiation.
IRB Review:
Type of Review: Expedited
Most Recent Approval: September 19, 1995
IRB Approval Number: 2332
Number of Human Subjects in the Last Reporting Period for this Project: 0
(Reporting periods vary.)
Type of Human Subjects Involvement:
Same protocol as protocol #46,176 / #1 except that the BPA drug will be delivered intravenously instead of orally and distal peripheral sites have been irradiated. There are no identifiably higher risks.
IRB Review:
Type of Review: Expedited
Most Recent Approval: September 19, 1995
IRB Approval Number: 2332
Number of Human Subjects in the Last Reporting Period for this Project: 0
(Reporting periods vary.)
Type of Human Subjects Involvement:
Subjects have distal lesions. Same as protocol 46,176 / #2, except permits reirradiation of subjects who have already undergone BNCT once previously under controlled conditions.
IRB Review:
Type of Review: Expedited
Most Recent Approval: September 19, 1995
IRB Approval Number: 2332
Number of Human Subjects in the Last Reporting Period for this Project: 0
(Reporting periods vary.)
Type of Human Subjects Involvement:
The same as protocol 46,176 / #2 except that proximal as opposed to only distal lesions are admitted. A minor degree of additional risk is involved due to the collateral irradiation of sensitive organs and tissues. Such additional risks will be assessed for each individual subject prior to administration of BNCT.