Expired Study
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Rockville, Maryland 20850


Purpose:

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


Study summary:

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.


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


NCT ID:

NCT00064246


Primary Contact:

Principal Investigator
David Scadden
AIDS Associated Malignancies Clinical Trials Consortium


Backup Contact:

N/A


Location Contact:

Rockville, Maryland 20850
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 14, 2017

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