Y 90 Ibritumomab Tiuxetan &Rituximab Relapsed or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beth Israel Deaconess Medical Center
• Treatments: Antibodies, Monoclonal; Cytarabine; Methotrexate; Rituximab

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