Completed

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

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What is being tested

rituximab

+ yttrium Y 90 ibritumomab tiuxetan
Biological
Radiation
Who is being recruted

Lymphoma

Over 18 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional
Study Start: December 2004

See protocol details

Summary

Principal SponsorMemorial Sloan Kettering Cancer Center
Last updated: January 17, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: December 1, 2004Actual date on which the first participant was enrolled.

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. 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 TitleA Pilot Study of Radiolabeled Indium-111 and Yttrium-90 Ibritumomab Tiuxetan in Primary CNS Lymphoma 
Principal SponsorMemorial Sloan Kettering Cancer Center
Last updated: January 17, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
10 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Lymphoma
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Memorial Sloan - Kettering Cancer CenterNew York, United StatesSee the location
CompletedOne Study Center