Phase I Study of Zevalin (90Y-Ibritumomab Tiuxetan) in Waldenstrom's Macroglobulinemia (Lymphoplasmacytic Lymphoma)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 试验地点
- 4
研究概览
简要总结
RATIONALE: Monoclonal antibodies such as yttrium Y 90 ibritumomab tiuxetan and rituximab can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of yttrium Y 90 ibritumomab tiuxetan in treating patients who have Waldenstrom's macroglobulinemia.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of yttrium Y 90 ibritumomab tiuxetan in patients with Waldenstrom's macroglobulinemia.
- Determine, preliminarily, the response of patients treated with this drug.
OUTLINE: This is a multicenter, dose-escalation study of yttrium Y 90 ibritumomab tiuxetan (IDEC-Y2B8).
Patients receive rituximab IV and indium In 111 ibritumomab tiuxetan (IDEC-In2B8) IV over 10 minutes on day 1. Patients then undergo gamma camera scans within 2-24 hours. Approximately 7-14 days after IDEC-In2B8, patients receive rituximab IV and IDEC-Y2B8 IV over 10 minutes. Treatment with IDEC-Y2B8 may repeat every 12 weeks in the absence of unacceptable toxicity or the achievement of a maximum cumulative dose.
Cohorts of 3-6 patients receive escalating doses of IDEC-Y2B8 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
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:
- •Diagnosis of Waldenstrom's macroglobulinemia confirmed by IgM gammopathy and bone marrow biopsy
- •Presence of lymphoplasmacytic cells
- •CD20+ plasma cell dyscrasia on the majority of malignant cells
- •Bone marrow involvement of 20-50% by core needle biopsy of at least 1.5 cm in length
- •Clinical indication for initiation of treatment, including 1 or more of the following characteristics:
- •Symptoms associated with the disease (e.g., fatigue, asthenia, or painful adenopathy)
- •IgM greater than 3 g/L
- •Progression as indicated by a rate of IgM rise of more than 0.5 g over 6 months
- •No myelodysplastic syndromes or profound hypocellularity of the bone marrow
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •More than 3 months
- •Hematopoietic
- •Absolute neutrophil count greater than 1,500/mm^3
- •Total B-lymphocyte count less than 5,000/mm^3
- •Platelet count greater than 100,000/mm^3
- •No hyperviscosity syndrome
- •Bilirubin no greater than 1.5 mg/dL
- •Not specified
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 1 year after study completion
- •No uncontrolled CNS disease
- •No serious nonmalignant disease that would preclude study participation
- •No other concurrent active malignancy except controlled skin cancer or prostate cancer
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF)
- •More than 4 months since prior rituximab
- •No prior radioimmunotherapy
- •Chemotherapy
- •No prior high-dose chemotherapy (unless patient has had prior back-up stem cell collections)
- •More than 6 weeks since prior chemotherapy
- •Endocrine therapy
- •More than 4 weeks since prior corticosteroids
- •Radiotherapy
- •No prior radiotherapy
- •Not specified
排除标准
- 未提供