An Early Phase I Study of IPdR Absorption, Metabolism, and Safety in Patients With Advanced Solid Tumors and Lymphomas

Summary

Background: \- The experimental drug IPdR is broken down in the body to IdUrd, which has been given to patients to find out if it can improve radiation therapy. IdUrd has to be given through a vein; therefore this new drug (IPdR) has been made which can be taken by mouth. Researchers are interested in determining whether IPdR should also be studied to find out if it can improve radiation therapy. The current study is to find out if people absorb the drug given by mouth. Objectives: \- To evaluate the levels of drug and its breakdown products in the blood following a single dose of IPdR by mouth. . Eligibility: \- Individuals at least 18 years of age who have been diagnosed with cancer (solid tumors or lymphomas) that have not responded to standard treatment. Design: * This study involves an initial dosing visit, one day of admission to the hospital for blood work, and a follow-up visit 14 days later. * Participants will be screened with a physical examination and medical history, as well as blood and urine samples. * Participants will receive a single dose of IPdR, and will provide multiple blood and urine samples for 24 hours after administration of the drug. * Fourteen days after receiving IPdR, participants will have another physical examination and additional blood and urine tests to evaluate how IPdR has been broken down by the body. * Cancer treatment will not be provided as part of this protocol.

Timeline

Start

2010-10-26

Primary completion

2012-07-30

Completion

2012-07-30

Publications

• Background Schulz CA, Mehta MP, Badie B, McGinn CJ, Robins HI, Hayes L, Chappell R, Volkman J, Binger K, Arzoomanian R, Simon K, Alberti D, Feierabend C, Tutsch KD, Kunugi KA, Wilding G, Kinsella TJ. Continuous 28-day iododeoxyuridine infusion and hyperfractionated accelerated radiotherapy for malignant glioma: a phase I clinical study. Int J Radiat Oncol Biol Phys. 2004 Jul 15;59(4):1107-15. doi: 10.1016/j.ijrobp.2003.12.007.
• Background Saif MW, Berk G, Cheng YC, Kinsella TJ. IPdR: a novel oral radiosensitizer. Expert Opin Investig Drugs. 2007 Sep;16(9):1415-24. doi: 10.1517/13543784.16.9.1415.
• Background Kinsella TJ. An approach to the radiosensitization of human tumors. Cancer J Sci Am. 1996 Jul-Aug;2(4):184-93.

Drugs

Indications