Mr. William J. McLoughlin
Sponsored Projects, MSKCC Box 40
1275 York Avenue
New York, NY 10021
Phone: 212-639-3273
Fax: 212-577-0760
Projects are approved by an IRB located at: Sloan-Kettering Institute for Cancer Research.
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-1210
Number of Human Subjects Projects reported: 2
Project Identifier: SKI-86-ER60407
Project Title:
Improving Cancer Treatment with Cyclotron Produced Radionuclides
Principal Investigator:
Dr. Steven M. Larson
Principal Investigator's Institution: Sloan-Kettering Institute
Project started in: 1986
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
Pilot and demonstration projects only, designed to obtain basic physiologic information
Project involves use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 4
Protocol/Subproject # 1
Protocol/Subproject Identifier: 93-41A
IRB Review:
Type of Review: Full Board
IRB Approval Number: closed 5/14/96
Number of Human Subjects who participated in this project/protocol during
05/14/95 - 05/14/96: 2
Type of Human Subjects Involvement:
O-15 water for assessing brain function blood flow.
Midazolam, a short term anesthetic -- mode of active research
In this protocol, oxygen-15 labelled water in saline is injected into the human subject. This radiopharmaceutical is a short-lived, positron emitting formulation classically utilized to evaluate blood flow using Positron Emission Tomography (PET).
This is a pilot study to determine if significant changes in regional cerebral blood flow, measured using oxygen-15 in water PET scanning, occur during: 1) Presentation of P300 paradigm (a tonal auditory task), and 2) During intravenous sedation with midazolam.
This is safe and effective for research application as defined under 21 CFR 361.1.
IRB Review:
Type of Review: Full Board
Most Recent Approval: December 12, 1995
Number of Human Subjects who participated in this project/protocol during
12/12/94 - 12/12/95: 0
Type of Human Subjects Involvement:
Pharmacokinetic
Radioiodinated IUdR for pharmacokinetic studies
Iododexyuridine, radiolabeled with I-131 and I-125 will be injected into the hepatic artery of patients with colorectal cancer. The purpose of the study will be to obtain biodistribution and biokinetic data, in order to understand the dosimetry of IUdR in radiolabeled form. As well, the biology of targeting, clearance are also determined. Kinetics are determined using a conjugate view gamma camera approach.
IRB Review:
Type of Review: Full Board
Most Recent Approval: February 28, 1995
IRB Approval Number: closed 2/13/96
Number of Human Subjects who participated in this project/protocol during
02/13/95 - 02/13/96: 0
Type of Human Subjects Involvement:
1) To study tumor incorporation and metabolism of I-125/I-131 in hepatic
metastases of colorectal cancer. (I-131 will be used to allow imaging of IUdR
incorporation; I-125 will be used because it will allow tissue incorporation and
potential treatment benefit.)
2) To study normal tissue incorporation and catabolism of I-125/I-131 IUdR.
3) To provide information for future studies which would study further dose
optimization to tumor targeting with I-125 labeled IUdR.
The types of experiments which are done under the DOE contract are primarily of a basic nature and involve either development in the laboratory of tumor seeking radiochemicals and radiopharmaceuticals or radiochemistry production procedures, or use of the cyclotron. Primarily, we use these tracers in animals to understand biologic questions. However, we also had a small number of patients that are studied each year as part of a validation project in which the principles of the radiopharmaceutical localization are tested. In the past, we have studied patients with I-124 labeled 3F8, a positron emitting antibody. These subjects (2 total) were studied using the I-124 3F8 to show that, as a new concept, quantitative dosimetry for radioimmunotherapy could be done with positron emitting radiolabels for monoclonal antibodies.
We are also embarking on an additional demonstration project that relates to I-131, I-123, I-124 and I-125 IUdR. a maximum of 10-15 patients per year would be studied in order to assess the biodistribution and targeting to tumors and the potential use of this agent in diagnosing or detecting the synthesis of DNA in tumors and the response of that synthesis to chemotherapy. In addition, preliminary studies that will go toward potential for therapy with I-125 IUdR will also be included. Again the studies supported under the DOE grant are of a preliminary nature, and intended to establish proof of principle more than direct clinical efficacy. More extensive clinical research studies would be supported under NIH auspices.
IRB Review:
Type of Review: Full Board
Most Recent Approval: November 28, 1995
Number of Human Subjects who participated in this project/protocol during
11/28/94 - 11/28/95: 0
Type of Human Subjects Involvement:
I-123, I-131, IUdR and I-124 IUdR for assessment of DNA synthesis in vivo
Lugol's solution to block thyroid uptake
The objective of this protocol is to demonstrate a) the feasibility and validity of imaging tumor cell proliferation with a radiolabeled analogue of thymidine, I-124 iododeoxyuridine (I-124 IUdR), and positron emission tomography (PET); b) To demonstrate that treatment response can be assessed in the "early" post-treatment period by I-124 IUdR and PET prior to changes observed on magnetic resonance (MR) or computerized tomographic (CT) imaging; and c) to demonstrate that the "early" post-treatment assessment with I-124 IUdR and PET correlates with patient survival.
This is safe and effective for research application as defined under 21 CFR 361.1.
Project Identifier: SKI-95-ER62039
Project Title:
Pharmacokinetics of Genetically Engineered Antibody Forms Using Positron Emission Tomography
Principal Investigator:
Dr. Steven M. Larson
Project started in: 1995
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project did not use human subjects in Fiscal Year 1996.
Explanation:
Development of specific labeled reagents and also on-going physics support work was required.
Funding Sources:
Physics of imaging detection, radiochemistry development and pre-clinical testing in animals formed the bulk of the work in this period; clinical protocols are pending.
Project does not involve use of multiple protocols/subprojects.
Protocol/Subproject Identifier: in preparation
IRB Review:
Type of Review: Full Board
Number of Human Subjects who participated in this project/protocol during
the Last Reporting Period for this Project: 0
Type of Human Subjects Involvement:
Basic pharmacology of radiolabeled genetically engineered forms
The objective of this study is to determine quantitative pharmacokinetics of radiolabeled antibodies and genetically engineered antibody forms. Positron Emission Tomography will be used primarily for this purpose. I-124 and Y-86 will be the primary radionuclides used.