NU 02H8: A PHASE I TRIAL OF REDOX REGULATION IN PATIENTS WITH RELAPSED NHL

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The potential subject is being asked to participate in this research study because he/she has cancer of the lymph glands (called B-cell lymphoma) that has either not responded to standard treatment or has returned after having shrunken in size or disappeared following previous chemotherapy or radiation treatments. Additional standard chemotherapy could cause the subject's disease to shrink or even disappear completely; however, experience has shown that the cancer will eventually come back. This research study involves the use of two therapies, Rituxan and (90)Yttrium-Zevalin, in combination with an investigational drug, Motexafin Gadolinium (MGd). Both Rituxan and (90)Yttrium-Zevalin are approved by the Food and Drug Administration (FDA) to treat lymphoma. Motexafin Gadolinium (MGd) is not currently approved by the FDA. Rituxan and (90)Yttrium-Zevalin are monoclonal antibodies. A monoclonal antibody is a laboratory-produced substance that reacts with a specific protein antigen (substance foreign to the body). Rituxan combines with a protein found on lymphoma cells and stimulates the body's immune system to destroy the lymphoma cells. (90)Yttrium-Zevalin is radioactive mouse antibodies, which also bind to this protein, and carry small particles of radioactivity to help identify (in scans) and kill lymphoma cells to possibly cause the disappearance of the subject's disease. (90)Yttrium-Zevalin is a type of radiation therapy. The study drug, MGd, has been used in combination with radiation therapy in prior clinical studies for subjects receiving radiation to the brain and chest. The drug has been used in combination with radiation to improve the results of radiation. STUDY OBJECTIVE - The purpose of this research study is: 1.) To determine the highest dose of MGd that can be safely combined with (90)Yttrium-Zevalin and Rituxan therapy. 2.) To determine the side effects of this anti-lymphoma therapy; and 3.) To evaluate whether the study treatment can slow, decrease or stop growth of the subject's lymphoma.