NCT00082836已完成不适用
A Pilot Study of Radiolabeled Indium-111 and Yttrium-90 Ibritumomab Tiuxetan in Primary CNS Lymphoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Dosimetry at 1, 24, and 48 hours
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •Performance status
- •Not specified
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Platelet count > 100,000/mm^3
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Bilirubin ≤ 2.0 mg/dL
- •Creatinine ≤ 2.0 mg/dL
- •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
- •More than 4 weeks since prior major surgery except diagnostic surgery
排除标准
- 未提供
结局指标
主要结局
Dosimetry at 1, 24, and 48 hours
次要结局
- Safety by NCI common toxicty criteria
- Radiographic response at 1 and 3 months
研究者
研究点 (1)
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