A Phase I/II Study of 131I-Tositumomab in Patients with Relapsed/Refractory Hodgkinâ??s Lymphoma
This study is being done to find the highest safe dose of 131I-Tositumomab (Bexxar®) that can be given to patients who have Relapsed/Refractory Hodgkin?s lymphoma, what side effects these patients get when they take Bexxar® and if Bexxar® is effective in treating Relapsed/Refractory Hodgkin?s lymphoma. Bexxar® works by delivering doses of radiation to cancer cells.
-Hodgkin?s lymphoma that is relapsed or refractory -Prior bone marrow transplant or not able to have a bone marrow transplant -All stages and types of Hodgkin?s lymphoma -Age 18 or greater -Prior chemotherapy is allowed -Prior radiation therapy is allowed -Good physical condition -Average blood counts -Good organ function -Less than 25% of bone marrow involved with Hodgkin?s lymphoma -If female, not pregnant or breast feeding -Measurable disease
Bexxar® is a radiolabeled anti-CD20 monoclonal antibody composed of a radioisotope (Iodine 131) and an antibody (Tositumomab). The antibody recognizes and attaches to a protein on lymphoma cells and can kill these cells. The radioisotope (Iodine 131) can help the antibody kill cells better. Bexxar® is given through a vein in the arm. Bexxar® is given in an outpatient setting.
12/19/2013 04:02 AM