Expired Study
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Burlington, Vermont 05401


Purpose:

RATIONALE: 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. Combining yttrium Y 90 ibritumomab tiuxetan with rituximab may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining yttrium Y 90 Ibritumomab tiuxetan with rituximab in treating patients who have relapsed or refractory diffuse large B-cell non-Hodgkin's lymphoma.


Study summary:

OBJECTIVES: - Determine the best overall response in patients with relapsed or refractory diffuse large B-cell non-Hodgkin's lymphoma treated with yttrium Y 90 ibritumomab tiuxetan and rituximab. - Determine the event-free survival of patients treated with this regimen. - Determine the toxicity of this regimen in these patients. OUTLINE: This is an open-label, multicenter study. - Radioimmunotherapy: Patients receive indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1 (for imaging only); yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8; and rituximab IV over 3-4 hours on days 1, 8, 15, 22, 29, and 36. - CNS ( central nervous system)prophylaxis: Patients receive CNS prophylaxis comprising intrathecal (IT) methotrexate or IT cytarabine on days 15, 22, 29, and 36 OR IT cytarabine (liposomal) on days 15 and 29. - Maintenance rituximab: Patients are assessed for response at week 14. Beginning at month 6, patients with stable or responding disease receive maintenance therapy comprising rituximab IV over 3-4 hours once weekly for 4 weeks. Maintenance therapy repeats every 6 months for 2 years (total of 4 courses) in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed diffuse large B-cell non-Hodgkin's lymphoma, including any of the following: - B-cell diffuse large cell variant - Immunoblastic - Mediastinal (thymic) large cell - T-cell/histiocyte-rich - Anaplastic large B-cell - Intravascular large B-cell - Lymphomatoid granulomatosis - Relapsed or refractory disease after at least 1 prior chemotherapy regimen and requires further treatment - Relapsed disease, defined as the following: - Appearance of any new lesion OR increase of at least 50% in the size of a previously involved site - 50% increase in greatest diameter of any previously identified node greater than 1 cm in the short axis OR in the sum of the perpendicular diameter (SPD) of more than 1 node - Progressive disease, defined as the following: - 50% increase from nadir in the SPD of any previously identified abnormal node - Appearance of any new lesion during or at the end of therapy - CD20-positive disease by immunohistochemistry - Bidimensionally measurable disease - At least 1 lesion at least 2.0 cm by CT scan - Less than 25% bone marrow involvement by lymphoma - No transformed lymphoma from indolent to aggressive - No HIV- or AIDS-related lymphoma - No hypocellular bone marrow - No marked reduction in bone marrow precursors of 1 or more cell lines (e.g., granulocytic, megakaryocytic, or erythroid) - No CNS lymphoma - Ineligible for myeloablative therapy OR refused transplantation - Ineligible for any other open yttrium Y 90 ibritumomab tiuxetan investigational protocols PATIENT CHARACTERISTICS: Age - 18 and over Performance status - WHO 0-2 Life expectancy - At least 3 months Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Lymphocyte count no greater than 5,000/mm^3 (for patients with small lymphocytic lymphoma) - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 2.0 mg/dL Renal - Creatinine no greater than 2.0 mg/dL Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 1 year after study participation - No concurrent serious nonmalignant disease or infection that would preclude study participation - No human antimurine antibody reactivity PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - No prior autologous bone marrow transplantation - No prior peripheral blood stem cell rescue - No prior failed stem cell collection - Prior rituximab within the past 90 days allowed provided patient has fludeoxyglucose-avid disease that is also indium In 111 ibritumomab tiuxetan-avid disease in at least 1 lesion - More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF) Chemotherapy - See Disease Characteristics Endocrine therapy - Not specified Radiotherapy - No prior radioimmunotherapy - No prior external beam radiotherapy (involved field or regional) to more than 25% of active bone marrow Surgery - More than 4 weeks since prior major surgery (except diagnostic surgery) Other - Recovered from all prior therapy - More than 4 weeks since prior therapy for lymphoma - More than 8 weeks since prior phase II investigational drugs - No other concurrent antineoplastic therapy


NCT ID:

NCT00073957


Primary Contact:

Study Chair
Robin Joyce, MD
Beth Israel Deaconess Medical Center


Backup Contact:

N/A


Location Contact:

Burlington, Vermont 05401
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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