A Phase I Study of Motexafin Gadolinium (Xcytrin, NSC 695238) and Involved Field Radiation Therapy for Intrinsic Pontine Glioma of Childhood
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- MTD defined as the dose at which fewer than one-third of patients experience DLT assessed using CTC version 2.0
研究概览
简要总结
Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as motexafin gadolinium may make the tumor cells more sensitive to radiation therapy. Phase I trial to study the effectiveness of motexafin gadolinium plus radiation therapy in treating children who have newly diagnosed brain stem glioma
详细描述
OBJECTIVES:
I. Determine the maximum tolerated dose (MTD) and schedule of motexafin gadolinium administered prior to radiotherapy in children with newly diagnosed diffuse intrinsic pontine glioma.
II. Determine the toxic effects of this drug given at the MTD in these patients.
III. Determine the intratumor and brain distribution of this drug by magnetic resonance imaging (MRI) in these patients.
OUTLINE: This is a dose-escalation study of motexafin gadolinium.
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
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically and radiographically (MRI) proven newly diagnosed diffuse intrinsic brainstem glioma
- •Greater than 50% intra-axial involvement of the pons, pons and medulla, pons and midbrain, or entire brainstem
- •Contiguous involvement of the thalamus or upper cervical cord allowed
- •Performance status - ECOG 0-2
- •More than 2 months
- •Absolute neutrophil count at least 1,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 10.0 g/dL (transfusion allowed)
- •No glucose 6 phosphate dehydrogenase deficiency
- •Bilirubin no greater than 1.5 times normal
- •SGOT or SGPT less than 1.5 times normal
- •Creatinine no greater than 1.5 times normal
- •Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No concurrent immunomodulating agents
- •No other concurrent chemotherapy
- •Concurrent corticosteroid therapy allowed for increased intracranial pressure only
- •No prior cranial radiotherapy
- •No prior motexafin gadolinium
- •No other concurrent experimental agents
排除标准
- 未提供
研究组 & 干预措施
Arm I
Approximately 2-5 hours before radiotherapy, patients receive motexafin gadolinium IV over 5 minutes. Patients undergo radiotherapy 5 days a week for 6 weeks.
干预措施: motexafin gadolinium (Drug)
Arm I
Approximately 2-5 hours before radiotherapy, patients receive motexafin gadolinium IV over 5 minutes. Patients undergo radiotherapy 5 days a week for 6 weeks.
干预措施: radiation therapy (Radiation)
Arm I
Approximately 2-5 hours before radiotherapy, patients receive motexafin gadolinium IV over 5 minutes. Patients undergo radiotherapy 5 days a week for 6 weeks.
干预措施: pharmacological study (Other)
结局指标
主要结局
MTD defined as the dose at which fewer than one-third of patients experience DLT assessed using CTC version 2.0
时间窗: 6 weeks
次要结局
未报告次要终点