USDOE Human Subjects Research Database, fiscal year 1995

Lawrence Berkeley National Laboratory

Project Identifier: LBNL-75-102-H01

Project Title:

Treatment of Cancer with Heavy Charged Particles (see LBL-93-4-65 in 1994 database)

Principle Investigator: Dr. Joseph R. Castro

Project started in: 1975

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:

Non-DOE Federal: National Cancer Institute (NCI)

Amount: $138,000 (Est.)
Comments:

Assignment #CA-19138

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: April 25, 1995
IRB Approval Number: CPHS 95-4-84

Number of Human Subjects in the Last Reporting Period for this Project: 500
(Reporting periods vary.)

Type of Human Subjects Involvement:

Ionizing Radiation and Radioactive Substances:

External use of ionizing radiation on human subjects.

• For diagnostic research.

Questionnaires, Surveys, Epidemiological Studies:

Use of personally identifiable data from questionnaires, surveys, or epidemiological studies.

• Use of data collected from subjects specifically for this project.
• Use of existing data that were collected for another purpose or 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])

OBJECTIVES

To evaluate the effectiveness of cancer treatment with heavy charged particle beams. The LBNL treatment phase of the project was discontinued after closure of the Bevalac in 1992; currently the project has been extended to allow follow-up of patients already treated. Societal benefits may include a better understanding of treatment options for individuals with cancer and a better understanding of the associated risks and side effects.

METHODOLOGY

Human subjects involvement includes follow-up of subjects already treated. The subject pool includes those treated at LBNL and at other Northern California Oncology Group sites. During the last year a new study for treatment of ocular melanoma was begun at the University of California at Davis (UCD) Crocker Cyclotron; subjects treated as part of that project will also be followed under this study. Follow-up includes gathering data from existing records as well as from post-treatment specific examinations.

IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES

Treatment of ocular melanoma patients with protons using the Crocker Cyclotron at UCD.

INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS

No additional risk accrues to the subjects from participation in the follow-up study.