USDOE Human Subjects Research Database, fiscal year 1995

Brookhaven National Laboratory

Project Identifier: BNL-90-229

Project Title:

Sn-117m (4+) DTPA in the Treatment of Osseous Metastases

Principle Investigator: Dr. Suresh C. Srivastava

Project started in: 1990

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: $30,000 (Est.)

DOE: Technology Transfer Funds

Amount: $168,000 (Est.)

Non-Federal: Private Funds (Diatech, Inc.)

Amount: $90,000 (Est.)

Total Funding: $288,000

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: February 01, 1995

Number of Human Subjects in the Last Reporting Period for this Project: 21
(Reporting periods vary.)

Type of Human Subjects Involvement:

Ionizing Radiation and Radioactive Substances:

External use of ionizing radiation on human subjects.

• For therapeutic research.

Internal administration of radioactive substances to human subjects.

• For therapeutic research.

Chemical Substances:

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

• 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])

All of the subjects treated with Sn-117m (4+) diethylenetriaminepertaacetate (DTPA) at levels of 0.143, 0.179, 0.229 and 0.286 millicurie per kilogram (mCi/kg) of body weight have shown partial to substantial pain relief. The plan is to increase the administered activity in steps of 25% and to observe the individuals for at least two months before going to the next level. We plan to escalate the dose up to a level at which level two marrow-toxicity is encountered (white blood cell count 2000-2900; platelets 50-75 x 1,000). This level is considered acceptable for chemotherapeutic regimens. We will, of course, continue to follow all patients for as long as possible and would consider retreatment after three months of observation. The risks to the subjects are only a slight possibility of infection and localized bleeding into the tissues from the injection. A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses.