A Phase II Study of Motexafin-Gadolinium (NSC 695238, IND #55583) and Involved Field Radiation Therapy for Intrinsic Pontine Glioma of Childhood
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- One Year Event-free Survival (EFS)
研究概览
简要总结
This phase II trial is studying how well giving motexafin gadolinium together with radiation therapy works in treating young patients with pontine glioma. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs, such as motexafin gadolinium, may make tumor cells more sensitive to radiation therapy. Giving motexafin gadolinium together with radiation therapy may kill more tumor cells.
详细描述
PRIMARY OBJECTIVES:
I. Evaluate the effect of combining motexafin gadolinium with daily fractionated radiotherapy on 1-year event-free survival of pediatric patients with intrinsic pontine glioma (brain stem glioma).
SECONDARY OBJECTIVES:
I. Evaluate the effect of combining motexafin gadolinium with daily fractionated radiotherapy on 1-year overall survival of these patients.
II. Determine the toxicities of motexafin gadolinium in combination with radiotherapy in these patients.
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
- •Diagnosis of intrinsic pontine glioma (brain stem glioma)
- •Clinical and radiographic (MRI) evidence of tumors that diffusely involve the brain stem (i.e., tumors that intrinsically [> 50% intra-axial] involve the pons or pons and medulla, pons and midbrain, or entire brain stem) allowed
- •Tumor may contiguously involve the thalamus or upper cervical cord
- •No more than 1 lesion/mass present at diagnosis
- •Karnofsky performance status (PS) 60-100% (age > 16 years) OR Lansky PS 60-100% (age ≤ 16 years)
- •Life expectancy ≥ 8 weeks
- •Absolute neutrophil count ≥ 1,000/mm³
- •Platelet count ≥ 100,000/mm³ (transfusion independent)
- •Hemoglobin ≥ 10 g/dL (RBC transfusions allowed)
- •Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR creatinine normal for age/gender (0.4-1.7 mg/dL)
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •ALT < 1.5 times ULN
- •No known glucose-6-phosphate dehydrogenase (G6PD) deficiency
- •If family history suggestive of congenital hemolytic anemia, patient must be screened for G6PD with G6PD activity test prior to study entry
- •No biliary obstruction
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No prior definitive therapy for this specific tumor
- •No prior cranial radiotherapy
- •Concurrent steroids and anticonvulsants allowed
- •No concurrent proton therapy
- •No concurrent intensity-modulated radiotherapy
- •No concurrent anticancer chemotherapy
- •No concurrent immunomodulating agents
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients receive motexafin gadolinium IV over 5-10 minutes once daily (prior to radiotherapy) 5 days a week for 6 weeks. Patients undergo focal cranial radiotherapy once daily 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
干预措施: motexafin gadolinium (Drug)
Arm I
Patients receive motexafin gadolinium IV over 5-10 minutes once daily (prior to radiotherapy) 5 days a week for 6 weeks. Patients undergo focal cranial radiotherapy once daily 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
干预措施: 3-dimensional conformal radiation therapy (Radiation)
结局指标
主要结局
One Year Event-free Survival (EFS)
时间窗: One year after enrollment.
Percentage probability of being event-free at 1 year following enrollment.
次要结局
- Overall Survival (OS)(One year after enrollment.)
- The Number of Patients Who Experience at Least One Grade 3 or Higher CTC Version 4 Toxicity.(One cycle of chemotherapy and radiation therapy; expected to be 42 days of treatment.)