USDOE Human Subjects Research Database, Fiscal Year 1995

Sloan-Kettering Institute

Public Information Contact:

Mr. William J. McLoughlin
Sponsored Projects, MSKCC Box 40
1275 York Avenue
New York, NY 10021

Phone: 212-639-3273
Fax: 212-753-4620

Institutional Review Board (IRB):

Projects are approved by an IRB located at: Sloan-Kettering Institute.
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

Human Subjects Projects:

Number of Human Subjects Projects reported: 2

SKI-86-ER60407

Improving Cancer Treatment with Cyclotron Produced Radionuclides

SKI-95-ER62039

Pharmacokinetics of Genetically Engineered Antibody Forms Using Positron Emission Tomography

Project Identifier: SKI-86-ER60407

Project Title:

Improving Cancer Treatment with Cyclotron Produced Radionuclides

Principle Investigator: Dr. Steven M. Larson
Principle Investigator's Institution: Sloan-Kettering Institute

Project started in: 1986

Fiscal Year 1995 Funding for Research on Human Subjects:

Project Funding Information:
Project received funding in Fiscal Year 1995.
Project used human subjects in Fiscal Year 1995.

Funding Sources:

DOE: Office of Health and Environmental Research OHER

Amount: $20,000 (Est.)
Comments:

Pilot and demonstration projects only, designed to obtain basic physiologic information

Information on Use of Human Subjects:

Project involves use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 1

Protocol/Subproject # 1
Protocol/Subproject Identifier: 94-14

IRB Review:
Type of Review: Full Board
Most Recent Approval: February 28, 1995

Number of Human Subjects in the Last Reporting Period for this Project: 5
(Reporting periods vary.)

Type of Human Subjects Involvement:

Ionizing Radiation and Radioactive Substances:

External use of ionizing radiation on human subjects.

• Other use of external ionizing radiation:

  Pharmacokinetic IUDR

Internal administration of radioactive substances to human subjects.

• Other internal administration of radioactive substances:

  Pharmacokinetic

Chemical Substances:

Internal use of chemical substances (solid, liquid, or gas) in human subjects.

• For clinical research.
• For therapeutic research.

Collection of Bodily Materials:

Collection of personally identifiable bodily materials (blood or blood products, cells, tissue, organs, waste).

• Use of bodily materials collected from subjects specifically for this project.

(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])

Iododeoxyuridine, radiolabeled with Iodine-131 and Iodine-125 was injected into the hepatic artery of patients with colorectal cancer. The purpose of the study was to obtain biodistribution and biokinetic data, in order to understand the dosimietry of IUDR in radiolabeled form. As well, the biology of targeting clearance was also determined. Kinetics were determined using a conjugate view gamma camera approach.

Project Identifier: SKI-95-ER62039

Project Title:

Pharmacokinetics of Genetically Engineered Antibody Forms Using Positron Emission Tomography

Principle Investigator: Dr. Steven M. Larson

Project started in: 1995

Fiscal Year 1995 Funding for Research on Human Subjects:

Project Funding Information:
Project received funding in Fiscal Year 1995.
Project did not use human subjects in Fiscal Year 1995.

Explanation:

The work so far has been to establish the positron labels for the antibodies and study the physics of iodine-124 and yttrium-86 imaging. This has been done.

Information on Use of Human Subjects:

Project does not involve use of multiple protocols/subprojects.

IRB Review:
Type of Review: Full Board
Most Recent Approval: September 09, 1994

Number of Human Subjects in the Last Reporting Period for this Project: 0
(Reporting periods vary.)

Type of Human Subjects Involvement:

Ionizing Radiation and Radioactive Substances:

Internal administration of radioactive substances to human subjects.

• Other internal administration of radioactive substances:

  Basic Pharmacology of radiolabeled genetically engineered forms

Chemical Substances:

Internal use of chemical substances (solid, liquid, or gas) in human subjects.

• For clinical research.

Collection of Bodily Materials:

Collection of personally identifiable bodily materials (blood or blood products, cells, tissue, organs, waste).

• Use of bodily materials collected from subjects specifically for this project.

Other use of human subjects:

Subjects will have human tumors that will be targeted with the radiolabeled genetically engineered antibody.

(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])

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.