Status:
COMPLETED
Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Recurrent Primary CNS Lymphoma
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed 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. ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00082836
Start Date
December 1 2004
Last Update
January 17 2013
Active Locations (1)
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1
Memorial Sloan - Kettering Cancer Center
New York, New York, United States, 10021