Dr. Sally J. DeNardo
1508 Alhambra Blvd, Suite 214
Sacramento, CA 95816
Phone: 916-734-3787
Fax: 916-451-2857
Projects are approved by an IRB located at: University of California, Davis.
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-1325
Number of Human Subjects Projects reported: 1
Project Identifier: UCD-91-DEFG0384ER60233
Project Title:
Radioimmunotherapy: Development of an Effective Approach
Principle Investigator:
Dr. Sally J. DeNardo
Project started in: 1991
Project Funding Information:
Project received funding in Fiscal Year 1995.
Project used human subjects in Fiscal Year 1995.
Funding Sources:
Total Funding: $471,534
Project involves use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 3
Protocol/Subproject # 1
Protocol/Subproject Identifier: 95-005R
IRB Review:
Type of Review: Full Board
Most Recent Approval: July 06, 1994
IRB Approval Number: 95-005R
Number of Human Subjects in the Last Reporting Period for this Project: 0
(Reporting periods vary.)
Type of Human Subjects Involvement:
To answer the fundamental scientific questions for the development of an effective approach for delivering cancer targeting systemic radiation therapy to currently incurable cancer with radiopharmaceuticals. In-111-2IT-BAD-Lym-1 is used for imaging and is administered intravenously, giving internal radiation exposure. Subjects receive one cycle of In-111-2IT-BAD-Lym-1. There are no direct benefits to subjects for participation in this protocol. The major risk of the research is from immunoglogin and radiopharmaceutical pyrogen reactions and antibody reactions. Lym-1 antibody effects have included fever, chills, rash and transient mild hypotension. The risks are reduced by careful monitoring of the subject during the procedure.
IRB Review:
Type of Review: Full Board
Most Recent Approval: January 09, 1995
IRB Approval Number: 95-447R
Number of Human Subjects in the Last Reporting Period for this Project: 1
(Reporting periods vary.)
Type of Human Subjects Involvement:
To answer the fundamental scientific questions for the development of an effective approach for delivering cancer targeting systemic radiation to currently incurable cancer with radiopharmaceuticals. This is a therapy protocol for advanced incurable cancer. Cu-67-2IT-BAT-Lym-1 is used for therapy and is administered intravenously giving internal radiation exposure. Subjects receive 4 cycles of Cu-67-2IT-BAT-Lym-1 given at 4 week intervals. The potential benefits from this research may be a favorable response in terms of tumor regression for advanced incurable cancer. The major risk of the research is from immunoglobin and radiopharmaceutical pyrogen reactions, antibody reactions, and radiation effects. Lym-1 antibody effects have included fever, chills, rash and transient mild hypotension. The major negative radiation effect encountered thus far has been transient marrow suppression. These risks are reduced by careful monitoring of the subject and the subject's blood during protocol participation.
IRB Review:
Type of Review: Full Board
Most Recent Approval: April 24, 1995
IRB Approval Number: 95-656R
Number of Human Subjects in the Last Reporting Period for this Project: 3
(Reporting periods vary.)
Type of Human Subjects Involvement:
To answer the fundamental scientific questions for the development of an effective approach for delivering cancer targeting systemic radiation therapy to currently incurable cancer with radiopharmaceuticals. In-111-DOTApeptideChL6 is used for imaging and is administered intravenously, giving internal radiation exposure. In-111/Y-90-DOTApeptideChL6 is used for therapy and is administered intravenously giving internal radiation exposure. Subjects receive 3 cycles of In-111/Y-90-DOTApeptideChL6 given at eight week intervals. Subjects participate in a pharmacokinetic study, receive marrow support consisting of pretherapy G-CSF stimulated and harvested autologous peripheral blood stem cells and Cyclosporin A to suppress HAMA response.
The potential benefits from this research may be a favorable response in terms of tumor regression for advanced incurable cancer. The major risk of the research is from immunoglobin and radiopharmaceutical pyrogen reactions, antibody reactions, and radiation effects. ChL6 antibody effects have included fever, chills, rash and transient mild hypotension. The major negative radiation effect encountered thus far has been transient marrow suppression. These risks are reduced by careful monitoring of the subject and the subject's blood during protocol participation.