Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Post-Transplant Lymphoproliferative Disorder
Post-transplant Lymphoproliferative Disorder, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma
About this trial
This is an interventional treatment trial for Post-transplant Lymphoproliferative Disorder
Eligibility Criteria
Inclusion Criteria: Histologically confirmed post-transplant lymphoproliferative disorder (PTLD) of 1 of the following stages: Stage III or IV Localized (not amenable to localized radiotherapy or excision) Recurrent The following histologies* are eligible: Polyclonal PTLD Monoclonal PTLD Diffuse large B-cell non-Hodgkin's lymphoma (NHL) Lymphoplasmacytic NHL Burkitt/Burkitt-like NHL Must not have completely responded during OR progressed after prior rituximab with or without chemotherapy No history of rapid disease progression while receiving prior chemotherapy Measurable disease Must have less than 25% bone marrow involvement with lymphoma Prior solid organ transplantation required Evaluation of malignant cells for Epstein-Barr virus (EBV) required EBV positive or negative allowed No pleural effusion No CNS lymphoma, including leptomeningeal disease No pulmonary involvement by NHL in patients with prior lung transplantation No HIV or AIDS-related lymphoma No hypocellular bone marrow (i.e., less than 15% cellularity) No marked reduction in bone marrow precursors of one or more cell lines (i.e., granulocytic, megakaryocytic, or erythroid) Performance status - Karnofsky 50-100% At least 3 months Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 150,000/mm^3 Bilirubin no greater than 2.5 mg/dL Creatinine no greater than 2.5 mg/dL Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study participation HIV negative No serious nonmalignant disease or infection that would compromise study objectives No presence of antimurine antibody reactivity No other concurrent active malignancy requiring therapy More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF) More than 6 weeks since prior rituximab No prior allogeneic bone marrow or hematopoietic stem cell transplantation No prior radioimmunotherapy for NHL More than 4 weeks since prior chemotherapy See Biologic therapy No prior radiotherapy to more than 25% of active bone marrow (involved field or regional) More than 4 weeks since prior major surgery except diagnostic surgery No other concurrent anticancer therapy
Sites / Locations
- AIDS - Associated Malignancies Clinical Trials Consortium
Arms of the Study
Arm 1
Experimental
Treatment (rituximab, yttrium Y 90 ibritumomab tiuxetan)
Phase I: Patients receive rituximab IV and indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1. Patients undergo 2 (or 3 if needed) imaging scans between days 1-6. In the absence of altered biodistribution, patients receive rituximab IV followed within 4 hours by IDEC-Y2B8 IV over 10 minutes on day 8. Phase II: Patients receive treatment as in phase I at the MTD of IDEC-Y2B8. Patients are followed monthly for 3 months, every 3 months for 2 years, and then every 6 months for 2 years.