A Pilot Study of Radiolabeled Indium-111 and Yttrium-90 Ibritumomab Tiuxetan in Primary CNS Lymphoma
Data Collection
Immune System Diseases+4
+ Immunoproliferative Disorders
+ Lymphatic Diseases
Treatment Study
Summary
Study start date: December 1, 2004
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.10 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
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