NCT00107289招募中2 期
Open Access Protocol of Targeted Radiotherapy With I-metaiodobenzylguanidine (I-MIBG) in Patients With Resistant Neuroblastoma or Malignant Chromaffin Cell Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Response (complete or partial)
研究概览
简要总结
The purpose of this research study is to find how active and safe 131 I-MIBG is in patients with resistant neuroblastoma, malignant pheochromocytoma and malignant paraganglioma.
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
- •Patients must have the diagnosis of NB in accordance with the International Criteria, i.e., either histopathology (confirmed by the MSKCC Department of Pathology) or BM involvement plus elevated urinary catecholamines.
- •Must have a history of tumor progression or recurrence or failure to achieve complete response with standard therapy.
- •Patients must have MIBG-avid NB and evaluable disease on MIBG scan at time of enrollment on protocol
- •Prior Therapy: At least 2 weeks should have elapsed since any biologic therapy. Three weeks should have elapsed since last dose of chemotherapy.
- •Age >1 year
- •Determination that radiation safety restrictions during therapy period can be implemented.
- •Stem cells: Patients for high does must have an autologous hematopoietic stem cell product cryopreserved and available for re-infusion after MIBG treatment. Patients for low dose do not require cryopreserved autologous hematopoietic stem cell product available. The minimum dose for peripheral blood stem cells is 2 X106 CD34+ cells/kg.
- •Minimum life expectancy of eight weeks
- •Signed informed consent indicating awareness of the investigational nature of this program.
- •Inclusion criteria for malignant CCT:
- •Patients must have the diagnosis of malignant CCT i.e. malignant pheochromocytoma or malignant paraganglioma
- •Patients must have MIBG-avid malignant CCT and evaluable disease on MIBG scan at time of enrollment on protocol
- •Prior Therapy: At least 2 weeks should have elapsed since any biologic therapy. Three weeks should have elapsed since last dose of chemotherapy.
- •Age between 1 and 21 years and able to cooperate with radiation safety restrictions during therapy period
- •Stem cells: Patients must have an autologous hematopoietic stem cell product cryopreserved and available for re-infusion after MIBG treatment. The minimum dose for peripheral blood stem cells is 2 X106 CD34+ cells/kg.
- •Minimum life expectancy of eight weeks.
- •Signed informed consent indicating awareness of the investigational nature of this program.
排除标准
- •Severe major organ toxicity. Specifically, renal, cardiac, hepatic, pulmonary, gastrointestinal and neurologic toxicity should all be grade 2 or less. A grade 3 hearing deficit is acceptable.
- •Active serious infections not controlled by antibiotics.
- •Pregnant women are excluded for fear of danger to the fetus. Therefore negative pregnancy test is required for all women of child-bearing age, and appropriate contraception is used during the study period.
- •Inability or unwillingness to comply with radiation safety procedures or protocol requirements.
研究组 & 干预措施
Radiation
Experimental
Patients will be treated with IV 131I-MIBG using 1-2 high dose(s) or up to 16 low doses.
Thyroid protection is commenced seven days (+/-2 days) prior to administration of 131I-MIBG and continued for up to 42 days after each 131I-MIBG treatment. Given that this is an open access protocol, re-enrollment is allowed per PI discretion. Patients who received this treatment previously are allowed to be re-enrolled if they meet the eligibility criteria. Re-enrollment can be to the same arm previously treated on (high dose versus low dose) or to the other arm. Patients will not be eligible for re-enrollment if they have already received 16 low doses or 4 high doses of 131I-MIBG.
干预措施: iobenguane I 131 (Drug)
结局指标
主要结局
Response (complete or partial)
时间窗: 2 years
次要结局
- Correlation between tumor self-absorbed dose and response and tumor volume decrease(2 years)
研究者
研究点 (1)
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