A Phase 2b Study Evaluating the Efficacy and Safety of Ultratrace™ Iobenguane I 131 Among Patients With Relapsed/Refractory High-Risk Neuroblastoma
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 21
- 主要终点
- Proportion of patients with complete or partial response, sustained over two assessments, following treatment. Response criteria for the primary endpoint are based on the International Neuroblastoma Response Criteria (INRC).
研究概览
简要总结
This is a multi-center, single arm trial of two doses of 18 mCi/kg of Ultratrace iobenguane I 131 administered to subjects with high-risk neuroblastoma. Iobenguane I 131 is a drug that has already been used in many children to treat neuroblastoma, and it is known to shrink some of the tumors, and cause manageable side effects. When administered intravenously, Iobenguane I 131 accumulates in the neuroblastoma cancer cells and causes them to die.
In this study the investigators are investigating the use of a new form of Iobenguane I 131 called Ultratrace iobenguane I 131. This form is expected to deliver higher amounts of radioactive I 131 to the neuroblastoma cells. The primary purpose of the study is to determine if Ultratrace iobenguane I 131 can be used to successfully treat high-risk neuroblastoma. The study will also assess the safety of Ultratrace iobenguane I 131 when given to patients with high-risk neuroblastoma.
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
- 12 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Patients will be excluded if any of the following conditions are observed:
- •Pregnant, or lactating females with the intent to breast feed. Females of child-bearing potential must have a negative serum pregnancy test prior to therapy. Males and females of reproductive age and childbearing potential must use effective contraception defined as abstinence or use of IUD, oral contraceptive, barrier and spermicide, or hormonal implant for the duration of their participation. Sexually active female patients using oral contraception will be required to use a second form of barrier birth control. All patients will be required to use effective contraception for 60 days following the last therapeutic dose of Ultratrace iobenguane I
- •Have disease of any major organ system that would compromise their ability to withstand therapy.
- •Receiving hemodialysis or have a renal obstruction, which would effect the urinary excretion of MIBG.
- •Is platelet transfusion dependent
- •Status post-allogeneic hematopoietic stem cell transplant.
- •Concomitant use of medications that inhibit uptake of Ultratrace iobenguane I
- •Have a known allergy to iobenguane, iodine or SSKI.
- •If patients and/or families who are physically and psychologically unable to cooperate with the radiation safety isolation or imaging requirements (sedation or general anesthesia permitted).
- •Administered prior chemotherapy within 30 days of study entry or have active malignancy (other than neuroblastoma) requiring additional treatment.
- •Any other condition, that in the opinion of the investigator, may compromise the safety or compliance of the subject or would preclude the subject from successful completion of the study.
- •Patient unable to receive at least one 15 mCi/kg dose per dosimetry findings.
研究组 & 干预措施
Ultratrace Iobenguane I 131
干预措施: Ultratrace Iobenguane I 131 (Drug)
结局指标
主要结局
Proportion of patients with complete or partial response, sustained over two assessments, following treatment. Response criteria for the primary endpoint are based on the International Neuroblastoma Response Criteria (INRC).
时间窗: Weeks 8, 16, 26, 39 and 52 after treatment
次要结局
- Change in use of narcotics for pain management(Weeks 8, 16, 26, 39 and 52 after treatment)
- Change in key tumor markers (HVA and VMA)(Weeks 8, 16, 26, 39 and 52 after treatment)
- Change in patient quality of life(Weeks 8, 16, 26, 39 and 52 after treatment)
- Overall survival(Weeks 8, 16, 26, 39 and 52 after treatment)