NCT00083135已完成1 期
I-MIBG Escalating Dose Rapid Sequence Double Infusion Followed By Autologous Stem Cell Infusion For Refractory Neuroblastoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 10
研究概览
简要总结
RATIONALE: Giving iodine I 131 metaiodobenzylguanidine (^131I-MIBG) may kill neuroblastoma cells by delivering radiation directly to the tumor. A stem cell transplant using the patient's stem cells may be able to replace blood-forming cells destroyed by radiation therapy.
PURPOSE: This phase I trial is studying the side effects and best dose of a double infusion of ^131I-MIBG followed by autologous stem cell transplantation in treating patients with refractory neuroblastoma.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated red marrow radiation dose delivered and associated toxic effects of escalating activity of iodine I 131 metaiodobenzylguanidine (^131I-MIBG) followed by autologous hematopoietic stem cell transplantation in patients with refractory neuroblastoma.
- Determine the number of days after stem cell transplantation to achieve absolute neutrophil count ≥ 500/mm^3 for 3 days and platelet count ≥ 20,000/mm^3 for 3 days (without transfusions) in patients treated with this regimen.
Secondary
- Determine the response rate in patients treated with this regimen, based on lesions measurable by CT or MRI at study entry, patients with ^131I-MIBG scan-positive lesions only, and patients with minimal residual tumor in bone marrow who have complete response by immunocytology and morphology.
- Determine the tumor absorbed radiation dose in patients with measurable soft tissue lesions treated with this regimen.
- Correlate, if possible, TP53 mutations with response in patients with accessible bone marrow tumor treated with ^131I-MIBG.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 1 Year 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of neuroblastoma
- •Confirmed by at least 1 of the following methods:
- •Histology
- •Clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites
- •High-risk disease
- •Poor response to induction therapy OR relapse defined by any of the following:
- •No response, stable disease, or mixed response after a minimum of 3 prior courses of chemotherapy
- •More than 100 tumor cells per 10^5 nucleated cells on bone marrow immunocytology after at least 3 prior courses of chemotherapy
- •Progressive disease at any time during or after therapy
- •Patients with massive bone marrow invasion (more than 50% replacement of bone marrow by tumor cells) are allowed
- •Must have positive iodine I 131 metaiodobenzylguanidine (^131I-MIBG) within the past 6 weeks or subsequent to any other prior antitumor therapy delivered within the past 6 weeks
- •Must meet the following criteria for minimum number of autologous stem cells:
- •Unpurged peripheral blood stem cells (PBSC)
- •Minimum of 1,500,000/mm^3 CD34-positive cells/kg
- •Collected products must have < 1 tumor cell/100,000 normal cells by immunocytology
- •PBSC purged with immunomagnetic beads
- •Minimum of 1,000,000/mm^3 viable CD34-positive cells/kg
- •Collected products must have < 1 tumor cell/100,000 normal cells by immunocytology
- •CD34-positive selected PBSC products are not allowed
- •Patients who had PBSC collected previously with no immunocytological testing available may use those products provided bone marrow is tumor free by bilateral bone marrow aspirate AND biopsy for morphology is performed within 4 weeks before PBSC collection
- •Patients with no tumor involvement in bone marrow at diagnosis and PBSC collection before any disease progression do not require documentation of negative bone marrow morphology
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •Less than 1 year
- •Hematopoietic
- •Absolute neutrophil count ≥ 500/mm^3
- •Platelet count ≥ 50,000/mm^3 (without transfusion)
- •Hemoglobin ≥ 8 g/dL (transfusion allowed)
- •AST and ALT ≤ 5 times normal
- •Bilirubin < 2 times normal
- •Creatinine ≤ 1.5 mg/dL
- •Glomerular filtration rate OR 12-hour creatinine clearance ≥ 60 mL/min/1.73m^2
- •Cardiovascular
- •Ejection fraction ≥ 55% by echocardiogram or MUGA OR
- •Fractional shortening ≥ 30% OR above lower limit of normal by echocardiogram
- •Normal lung function
- •No dyspnea at rest
- •No exercise intolerance
- •No oxygen requirement
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Able to cooperate physically and psychologically with radiation isolation
- •No disease of any major organ system that would preclude study participation
- •No active infection requiring antivirals, antibiotics, or antifungals
- •No weight that would require exceeding a maximum total allowable dose of ^131I-MIBG
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- 另有 20 项未显示
排除标准
- 未提供
研究者
研究点 (10)
Loading locations...
相似试验
Available
不适用
131-I-MIBG Therapy for Refractory Neuroblastoma, Expanded Access ProtocolChildhood Metastatic PheochromocytomaNeuroblastomaNCT01163383John Maris
已完成
2 期
131 I-MIBG in Treating Patients With Refractory or Relapsed NeuroblastomaNeuroblastomaNCT00293319University of California, San Francisco164
已完成
3 期
High Dose I-131 Metaiodobenzylguanidine(MIBG) for Metastatic Neuroendocrine TumorsNeuroendocrine TumorsMetastases, NeoplasmNCT00037869M.D. Anderson Cancer Center15
已完成
2 期
N2001-02: I-MIBG With Intensive Chemotherapy and Autologous Stem Cell Rescue for High-Risk NeuroblastomaNeuroblastomaNCT00253435New Approaches to Neuroblastoma Therapy Consortium50
已完成
不适用
I-131 MIBG(I-131 Meta-Iodobenzylguanidine) radiotherapy for malignant neuroendocrine tumorsmalignant neuroendocrine tumorsJPRN-UMIN000017057Kagoshima university hospital Department of Radiology25