Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Recurrent Primary CNS Lymphoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Pilot Study of Radiolabeled Indium-111 and Yttrium-90 Ibritumomab Tiuxetan in Primary CNS Lymphoma

Conditions
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Lymphoma

Intervention / Treatment
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* Biological: rituximab
* Radiation: yttrium Y 90 ibritumomab tiuxetan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: rituximab|nan|
|Radiation: yttrium Y 90 ibritumomab tiuxetan|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dosimetry at 1, 24, and 48 hours |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety by NCI common toxicty criteria |  |  | 
| Radiographic response at 1 and 3 months |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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primary central nervous system non-Hodgkin lymphoma