CLINICAL TRIAL: BEXXAR COMBINED WITH EXTERNAL BEAM RADIATION THERAPY FOR PATIENT

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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. This is a single institution Phase II study to determine the efficacy and safety of Bexxar (Tositumomab anti-CD20 monoclonal antibody and 131I-tositumomab) combined with external beam radiation therapy in patients with relapsed, bulky Non-Hodgkin's Lymphoma (NHL). A course of therapy will consist of an initial dosimetric/biodistribution study utilizing 450 mg tositumomab i.v. (to optimize biodistribution) followed by 5 mCi 131I on 35 mg of tositumamb i.v., with gamma camera imaging of patients at 3 time points over 7 days for purposes of calculating a patient specific dose/activity of 131I-tositumomab calculated to deliver a whole body absorbed dose of 75 cGy for patients with platelet counts >= 150,000 and 65 cGy for patients with platelet counts >= 100,000 but < 150,000. The therapeutic dose of 131I-tositumomab will be given on 35 mg of tositumomab and preceded by infusion of 450 mg tositumomab 7 days following administration of the dosimetric dose. This is the standard methodology (dose and schedule) for administration of Bexxar as approved by the FDA for the treatment of patients with low grade and transformed B cell NHL. The external beam radiation to the bulky site of disease is considered standard of care, and is not investigational. This treatment will begin within 24 hours of the therapeutic dose of Bexxar.