NCT00293319已完成2 期
I-Metaiodobenzylguanidine (I-MIBG) Therapy for Refractory Neuroblastoma, A Phase II Study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 164
- 试验地点
- 6
- 主要终点
- Acute and late toxicities
研究概览
简要总结
RATIONALE: Radioactive drugs, such as 131 I-MIBG, may carry radiation directly to tumor cells and not harm normal cells.
PURPOSE: This phase II trial is studying how well 131 I-MIBG works in treating patients with refractory or relapsed neuroblastoma.
详细描述
OBJECTIVES:
Primary
- Determine if iodine I 131 metaiodobenzylguanidine can provide palliative therapy for patients with refractory or relapsed neuroblastoma.
- Determine the acute and late toxicity of this regimen in these patients.
Secondary
- Determine disease and symptom responses of patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Original diagnosis of neuroblastoma based on 1 of the following criteria:
- •Histopathology
- •Elevated urine catecholamines with typical tumor cells in the bone marrow
- •Refractory or relapsed disease, meeting 1 of the following criteria:
- •Failure to respond to standard therapy (e.g., combination chemotherapy with or without radiotherapy and surgery)
- •Evidence of disease progression (i.e., any new lesion or an increase in size of > 25% of a pre-existing lesion) at any time
- •Evaluable disease by MIBG scan within 6 weeks of study entry
- •PATIENT CHARACTERISTICS:
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •Negative pregnancy test
- •Bilirubin < 2 times normal
- •AST/ALT ≤ 10 times normal
- •Creatinine ≤ 2 mg/dL
- •Absolute neutrophil count* ≥ 750/mm^3 (transfusion independent)
- •Platelet count* ≥ 50,000/mm^3 (20,000/mm^3 if stem cells are available and platelet transfusion independent)
- •Hemoglobin* ≥ 10 g/dL (transfusion allowed)
- •No dyspnea at rest
- •No exercise intolerance
- •No oxygen requirement
- •No clinically significant cardiac dysfunction
- •No disease of any major organ system that would preclude study compliance
- •No active infection that meets grade 3 or 4 toxicity criteria NOTE: *Patients with granulocytopenia and/or thrombocytopenia due to tumor metastases to the bone marrow may be eligible at the discretion of the principal investigator
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Recovered from prior therapy
- •At least 2 weeks since prior antitumor therapy
- •At least 3 months since prior radiotherapy to any of the following fields:
- •Craniospinal
- •Total abdominal
- •Whole lung
- •Total body
- •At least 1 day since prior cytokine therapy (e.g., filgrastim [G-CSF], sargramostim [GM-CSF], interleukin-6, or epoetin alfa)
- •Prior iodine I 131 metaiodobenzylguanidine allowed provided it was given more than 6 months ago AND patient has adequate hematopoietic stem cells available
- •No concurrent hemodialysis
排除标准
- 未提供
结局指标
主要结局
Acute and late toxicities
Ability of iodine I 131 metaiodobenzylguanidine to provide palliative therapy
次要结局
- Disease and symptom responses
研究者
Katherine Matthay
Professor, Department of Pediatrics
University of California, San Francisco
研究点 (6)
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