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 1998.
Project did not use human subjects in Fiscal Year 1998.
Explanation:
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: 2
Protocol/Subproject # 1
Protocol/Subproject Identifier: 91-136A(2)
IRB Review:
Type of Review: Full Board
Most Recent Approval: December 09, 1997
Number of Human Subjects who participated in this project/protocol during
12/09/96 - 12/09/97: 0
Type of Human Subjects Involvement:
Pharmacokinetic IUdR
Radioiodinated IUdR for pharmacokinetic studies
In general, 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 radiochemical production procedures, or the use of the cyclotron. Primarily, we use these tracers in animals to understand biologic questions. However, we also do have a small number of patients that are studied on occasion as part of a validation project in which the principles of the radiopharmaceutical localization are tested.
For example, Iodoexyuridine (IUdR), radiolabeled with I-131 and I-125 may 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. Also, the biology of targeting and clearance are determined. Kinetics are determined using a conjugate view gamma camera.
IRB Review:
Type of Review: Full Board
Most Recent Approval: November 26, 1996
Number of Human Subjects who participated in this project/protocol during
11/26/95 - 11/26/96: 0
Type of Human Subjects Involvement:
I-123, I-131, IUdR and I-124 IUdR for the 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) 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) that the "early" post-treatment assessment with I-124 IUdR and PET correlates with patient survival.
This protocol is safe and effective for research applications as defined under 21 CFR 361.1.
In general, 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 radiochemical production procedures, or the use of the cyclotron. Primarily, we use these tracers in animals to understand biologic questions. However, we also do have a small number of patients that are studied on occasion as part of a validation project in which the principles of the radiopharmaceutical localization are tested.
Project Identifier: SKI-95-ER62039
Project Title:
Pharmacokinetics of Genetically Engineered Antibody Forms Using Positron Emission Tomography
Principal Investigator:
Dr. Steven M. Larson
Principal Investigator's Institution: Sloan-Kettering Institute for Cancer Research
Project started in: 1995
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project did not use human subjects in Fiscal Year 1998.
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: 97-017
IRB Review:
Type of Review: Full Board
Most Recent Approval: April 08, 1997
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:
Basic pharmacology of radiolabeled genetically engineered forms
The objective of this study is to quantitatively determine the pharmacokinetics of radiolabeled antibodies and genetically engineered antibody forms. Positron emission tomography (PET) will be used for any radionuclide work involving human subjects. I-124 will be the primary radionuclide used. At present, this project will study about 15 patients per year, using positron labeled antibodies I-124 A33, under protocol 97-17 (A. Cohen and S. Larson, Principal Investigators). None of the approvals are complete at this time. All studies will be performed after IRB approval, and will include full disclosure and safeguards of the IRB monitored informed consent process. In addition, we anticipate that the additional work will be performed in animals to study basic aspects of tumor targeting. In general, 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 radiochemical production procedures, or the use of the cyclotron. Primarily, we use these tracers in animals to understand biological questions. However, we also have a small number of patients that are studied on occasion as part of a validation project in which the principles of the radiopharmaceutical localization are tested. DOE funding has been used to develop production and chemistry schedules for I-124, as well as detailed imaging physics studies for quantitative PET imaging in phantoms. We have intended I-124 for use in these patient studies. No studies have as yet been done. We have had to delay the implementation of the I-124 human studies for 2 reasons: a) the ready supply of radiopharmaceutical grade I-124 has not yet been feasible; b) A33 humanized, has still been tested in trials as a non-radioactive form, under other support PO1-CA 33049.
We intend to implement this trial as soon as the I-124 is available through this CRADA which has been established. Approximately 15 patient studies are planned under this approved protocol.