Non Hodgkin Lymphoma Clinical Trial
Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Non-Hodgkin’s Lymphoma
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.
PURPOSE: This phase II trial is studying how well giving yttrium Y 90 ibritumomab tiuxetan together with rituximab works in treating patients with progressive non-Hodgkin's lymphoma.
Full Description
OBJECTIVES:
Determine the efficacy of yttrium Y 90 ibritumomab tiuxetan and rituximab, in terms of overall response rate (complete, unconfirmed complete, and partial) and duration of response, in patients with transformed CD20+ B-cell non-Hodgkin's lymphoma.
Determine the safety of this regimen in these patients.
Determine the event-free survival and time to treatment progression in patients treated with this regimen.
Determine the immunogenicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive rituximab IV followed within 4 hours by indium In 111 ibritumomab tiuxetan IV (for imaging) over 10 minutes on day 1. Patients undergo 1 (or 2 if needed) imaging scan between days 2-5. In the absence of altered biodistribution, patients receive rituximab IV followed within 4 hours by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.
Patients are followed monthly for 3 months, every 3 months for 2 years, and then every 6 months for 2 years.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed transformed CD20+ B-cell non-Hodgkin's lymphoma (NHL)
Transformation defined as:
Progression to a more aggressive diffuse lymphoma, excluding conversion to a more aggressive grade of follicular lymphoma (e.g., WHO/REAL follicular center, large, grade III NHL)
Initial large cell follicular lymphoma must progress to a diffuse large cell lymphoma
De novo transformed NHL ineligible
Requiring treatment as determined by any of the following characteristics:
An increase in overall tumor size
Presence of B symptoms
Presence of masses that are causing ongoing clinical symptomatology
Must have less than 25% bone marrow involvement with lymphoma
Must have received and either relapsed or failed to respond to prior therapy for initial low grade or follicular NHL
Must have bidimensionally measurable disease defined as:
Greater than 2 cm OR 1.5 cm if 0.5 cm slices are used during spiral CT scan
Nonmeasurable disease includes any of the following:
Bone lesions
Leptomeningeal disease
Ascites
Pleural or pericardial effusion
Inflammatory breast disease
Lymphangitis cutis/pulmonis
Abdominal masses that are not confirmed and followed by imaging techniques
Cystic lesions
Lesions that are situated in a previously irradiated area
No expected impairment in bone marrrow reserve meeting any of the following criteria:
Platelet count less than 150,000/mm^3
Hypocellular bone marrow (less than 15% cellularity)
Marked reduction in bone marrow precursors of one or more cell lines (e.g., granulocytic, megakaryocytic, or erythroid)
History of failed stem cell collection
Patients with peritoneal invasion and/or ascites with positive cytology for lymphoma OR pleural invasion and/or effusion with positive cytology for lymphoma are eligible only if their effusion or ascites can be tapped dry
No significant remaining malignant effusion or ascites at the time of study drug administration
No known meningeal lymphoma or known parenchymal CNS lymphoma NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age
18 and over
Performance status
0-2
Life expectancy
Not specified
Hematopoietic
See Disease Characteristics
Absolute neutrophil count at least 1,500/mm^3
Lymphocyte count no greater than 5,000/mm^3
Platelet count at least 150,000/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 treatment
HIV negative
No other malignancy except nonmelanoma skin cancer unless patient has completed therapy and is considered to be at less than 30% risk of relapse
No human anti-mouse antibody (HAMA) reactivity (patients with prior exposure to murine antibodies)
PRIOR CONCURRENT THERAPY:
Biologic therapy
See Radiotherapy
At least 3 weeks since prior anticancer immunotherapy (6 weeks for rituximab) and recovered
More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF)
No prior myeloablative therapy with bone marrow transplantation or peripheral blood stem cell rescue
Chemotherapy
See Biologic therapy
At least 3 weeks since prior anticancer chemotherapy (6 weeks for nitrosourea or mitomycin) and recovered
Endocrine therapy
No concurrent systemic corticosteroids with either of the following dose schedules:
No greater than 50 mg of prednisone as a single dose (or equivalent)
No greater than 50 mg of prednisone per dose (or equivalent) for more than 6 doses
Radiotherapy
See Disease Characteristics
At least 3 weeks since prior anticancer radiotherapy and recovered
No prior radioimmunotherapy, including yttrium Y 90 ibritumomab tiuxetan
No prior external beam radiotherapy to more than 25% of active bone marrow (involved field or regional)
Surgery
At least 3 weeks since prior anticancer surgery and recovered
More than 4 weeks since prior major surgery (other than diagnostic surgery)
Other
At least 3 weeks since other prior anticancer therapy and recovered
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There are 80 Locations for this study
Little Rock Arkansas, 72205, United States
Burbank California, 91505, United States
La Jolla California, 92093, United States
San Diego California, 92120, United States
Lewes Delaware, 19958, United States
Newark Delaware, 19713, United States
Aurora Illinois, 60507, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60637, United States
Joliet Illinois, 60435, United States
Urbana Illinois, 61801, United States
Urbana Illinois, 61801, United States
Beech Grove Indiana, 46107, United States
Michigan City Indiana, 46360, United States
Richmond Indiana, 47374, United States
Salina Kansas, 67401, United States
Topeka Kansas, 66604, United States
Topeka Kansas, 66606, United States
Lewiston Maine, 04240, United States
Elkton MD Maryland, 21921, United States
Boston Massachusetts, 02115, United States
Boston Massachusetts, 02115, United States
Boston Massachusetts, 02118, United States
Kalamazooaa Michigan, 49001, United States
Kalamazoo Michigan, 49007, United States
Kalamazoo Michigan, 49007, United States
Springfield Missouri, 65802, United States
Springfield Missouri, 65804, United States
Springfield Missouri, 65807, United States
Billings Montana, 59101, United States
Billings Montana, 59101, United States
Billings Montana, 59101, United States
Billings Montana, 59101, United States
Billings Montana, 59107, United States
Billings Montana, 59107, United States
Bozeman Montana, 59715, United States
Butte Montana, 59701, United States
Great Falls Montana, 59405, United States
Great Falls Montana, 59405, United States
Helena Montana, 59601, United States
Kalispell Montana, 59901, United States
Kalispell Montana, 59901, United States
Kalispell Montana, 59901, United States
Missoula Montana, 59801, United States
Missoula Montana, 59804, United States
Missoula Montana, 59807, United States
Missoula Montana, 59807, United States
Omaha Nebraska, 68114, United States
Keene New Hampshire, 03431, United States
Lebanon New Hampshire, 03756, United States
Rochester New Hampshire, 03867, United States
Voorhees New Jersey, 08043, United States
Bronx New York, 10466, United States
Glens Falls New York, 12801, United States
New York New York, 10021, United States
Stony Brook New York, 11794, United States
Chapel Hill North Carolina, 27599, United States
Goldsboro North Carolina, 27534, United States
Goldsboro North Carolina, 27534, United States
Rutherfordton North Carolina, 28139, United States
Wilson North Carolina, 27893, United States
Winston-Salem North Carolina, 27157, United States
Cleveland Ohio, 44106, United States
Columbus Ohio, 43210, United States
Dayton Ohio, 45405, United States
Dayton Ohio, 45406, United States
Dayton Ohio, 45409, United States
Dayton Ohio, 45415, United States
Dayton Ohio, 45428, United States
Dayton Ohio, 45429, United States
Findlay Ohio, 45840, United States
Kettering Ohio, 45429, United States
Middletown Ohio, 45044, United States
Troy Ohio, 45373, United States
Xenia Ohio, 45385, United States
Bethlehem Pennsylvania, 18015, United States
Anderson South Carolina, 29621, United States
Spartanburg South Carolina, 29303, United States
Spartanburg South Carolina, 29303, United States
Sioux Falls South Dakota, 57105, United States
Sioux Falls South Dakota, 57117, United States
Temple Texas, 76508, United States
American Fork Utah, 84003, United States
Logan Utah, 84321, United States
Murray Utah, 84107, United States
Ogden Utah, 84403, United States
Provo Utah, 84604, United States
Saint George Utah, 84770, United States
Salt Lake City Utah, 84106, United States
Salt Lake City Utah, 84143, United States
Berlin Vermont, 05602, United States
Burlington Vermont, 05401, United States
Richmond Virginia, 23298, United States
Sheridan Wyoming, 82801, United States
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