Non Hodgkin Lymphoma Clinical Trial
Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Recurrent Primary CNS Lymphoma
Summary
RATIONALE: Monoclonal antibodies, such as rituximab and yttrium Y 90 ibritumomab tiuxetan, can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells.
PURPOSE: This clinical trial is studying how well giving yttrium Y 90 ibritumomab tiuxetan together with rituximab works in treating patients with recurrent primary CNS lymphoma.
Full Description
OBJECTIVES:
Primary
Determine the absorbed radiation doses of CNS lesions after administration of indium In 111 ibritumomab tiuxetan (for imaging) in patients with recurrent primary CNS lymphoma.
Secondary
Determine the safety of a therapeutic dose of yttrium Y 90 ibritumomab tiuxetan in these patients.
Tertiary
Determine the radiographic response in patients treated with this drug.
OUTLINE: Patients receive rituximab IV on day 1. Within 4 hours after rituximab administration, patients receive indium In 111 ibritumomab tiuxetan IV over 10 minutes. Patients then undergo whole body imaging. Patients whose dosimetry indicates that their CNS lesion would receive a sufficient radioimmunotherapy dose receive a therapeutic dose of yttrium Y 90 ibritumomab tiuxetan IV over 20-30 minutes on day 7.
Patients are followed monthly for 3 months, every 3 months for 2 years, and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed non-Hodgkin's lymphoma (NHL)
Recurrent disease
Isolated CNS relapse of systemic NHL allowed
Primary CNS lymphoma
Measurable gadolinium-enhancing lesion on MRI of the brain
No impaired bone marrow reserve
No hypocellular bone marrow
No marked reduction in bone marrow precursors of one or more cell lines (granulocytic, megakaryocytic, erythroid)
No pleural effusion
No chronic lymphocytic leukemia
No AIDS-related lymphoma
PATIENT CHARACTERISTICS:
Age
Adult
Performance status
Not specified
Life expectancy
Not specified
Hematopoietic
Platelet count > 100,000/mm^3
Absolute neutrophil count ≥ 1,500/mm^3
Hepatic
Bilirubin ≤ 2.0 mg/dL
Renal
Creatinine ≤ 2.0 mg/dL
Other
HIV negative
No serious nonmalignant disease that would preclude study participation
No infection
No anti-murine antibody reactivity*
No human anti-mouse antibodies
Not pregnant
Negative pregnancy test NOTE: *Results must be available prior to study entry for patients who received prior murine antibodies or proteins, other than rituximab
PRIOR CONCURRENT THERAPY:
Biologic therapy
See Radiotherapy
No prior stem cell transplantation
No prior myeloablative therapies with autologous bone marrow transplantation or peripheral blood stem cell rescue
No prior failed stem cell collection
More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF)
Chemotherapy
No more than 1 prior chemotherapy regimen
Endocrine therapy
Not specified
Radiotherapy
No prior radioimmunotherapy
No prior whole-brain radiotherapy
No prior external beam radiotherapy (involved field or regional) to > 25% of active bone marrow
Surgery
More than 4 weeks since prior major surgery except diagnostic surgery
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There is 1 Location for this study
New York New York, 10021, United States
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