Study of Bexxar Combined With External Beam Radiation Therapy for Patients With Relapsed, Bulky Non-Hodgkin's Lymphoma
We hope to learn whether I-131 tositumomab combined with external beam radiation therapy is an effective means of treating relapsed, bulky non-Hodgkin's lymphoma. The purpose of the study is to determine the overall response rate with responses described as: Site-dependent and overall CR and functional CR (CR of CRu(Complete Response Unconfirmed)/PR with PET negativity), or PR rates.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : SSKI
- drug : Tositumomab and iodine I 131 tositumomab
- procedure : External beam radiotherapy
Phase: Phase 2
Ages Eligible For Study:
- Histologically confirmed low grade CD20+ B cell NHL patients who have relapsed after chemotherapy or are chemotherapy resistant and have one or more sites of disease measuring more than 5 cm. - The patients must have failed at least one chemotherapy regimen - No anticancer treatment for three weeks prior to study initiation (six weeks if Rituximab, nitrosourea or Mitomycin C), and fully recovered from all toxicities associated with prior surgery, radiation, chemotherapy or immunotherapy - An IRB approved signed informed consent - Age greater and or equal to 19 years - Expected survival of at least 6 months - Prestudy Performance Status of 0, 1 or 2 according to the WHO - Acceptable laboratory status within 2 weeks prior to patient enrollment including: - ANC of at least 1,500/mm^3, platelet count at least 100,000/mm3, Hct greater than 30% and Hgb greater than 9.0 gm - Bilirubin less than or equal to 2.0, Creatinine less than or equal to 2.0 - Bone marrow involvement with lymphoma less than 25% (bilateral bone marrow) within 6 weeks of enrollment - Acceptable birth control method for men and women of reproductive potential - Female patients who are not pregnant or lactating