List of Ongoing Clinical Trials: Patient Summary

S0016
A Phase III Trial CHOP + Iodine-131-Labeled Monoclonal Anti-B1 Antibody (Tositumomab) For Treatment of Newly Diagnosed Follicular Non-Hodgkin’s Lymphomas

Summary
The purpose of this study is to find out if a combination of drugs (called CHOP) either alone or followed by an antibody (rituximab) or a radioactive antibody (Iodine-131 anti-B1 antibody - also called tositumomab), is able to stop the growth of cancer in patients. This study is also trying to find out if the side effects of this treatment are tolerable. The rituximab antibody is a protein which is partly of mouse origin and partly of human origin. The Iodine-131 anti-B1 antibody is a mouse antibody attached to radioactive Iodine (radiolabeled). These antibodies attach to white blood cells (B cells) in your blood and tumor.

The combination of CHOP chemotherapy and these antibodies have been used to treat patients with lymphoma and have been shown to be active against lymphoma. CHOP chemotherapy has been used for 30 years to treat patients with lymphomas and results in tumor shrinkage in 60 - 90% of patients. This study is being done to see if patients treated with CHOP chemotherapy followed by the rituximab antibody or by tositumomab may have longer lasting tumor shrinkage, and hopefully cures, than patients treated with CHOP chemotherapy alone. We also want to find out whether either of the two antibody treatments increase the side effects of CHOP treatment.

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