yttrium y 90 ibritumomab tiuxetan and rituximab in treating patients with post-transplant lymphoproliferative disorder

Conditions: Post-transplant Lymphoproliferative Disorder; Recurrent Adult Burkitt Lymphoma; Recurrent Adult Diffuse Large Cell Lymphoma; Stage III Adult Burkitt Lymphoma; Stage III Adult Diffuse Large Cell Lymphoma; Stage IV Adult Burkitt Lymphoma; Stage IV Adult Diffuse Large Cell Lymphoma; Waldenström Macroglobulinemia

Summary: phase i/ii trial to study the effectiveness of combining yttrium y 90 ibritumomab tiuxetan with rituximab in treating patients who have localized or recurrent lymphoproliferative disorder after an organ transplant. monoclonal antibodies such as yttrium y 90 ibritumomab tiuxetan and rituximab can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells

objectives: i. determine the safety and tolerability of yttrium y 90 ibritumomab tiuxetan (idec-y2b8) in patients with post-transplant lymphoproliferative disorder. ii. determine the safety and toxicity profile of idec-y2b8 and rituximab in these patients. iii. correlate the epstein-barr virus viral load with response and relapse in patients treated with this regimen. outline: this is a multicenter, dose-escalation study of yttrium y 90 ibritumomab tiuxetan (idec-y2b8). 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.cohorts of 6 patients receive escalating doses of idec-y2b8 until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose at which no more than 1 of 6 patients experience dose-limiting toxicity. 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.

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