Phase I Study of Concurrent Cereport and Carboplatin With Radiation Therapy for Children With Newly-Diagnosed Brain Stem Gliomas
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 19
- 主要终点
- Progression Free Survival
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as carboplatin and lobradimil may make the tumor cells more sensitive to radiation therapy.
PURPOSE: Phase I trial to study the effectiveness of combining radiation therapy with carboplatin and lobradimil in treating children who have newly diagnosed brain stem gliomas.
详细描述
OBJECTIVES:
- Determine the maximum tolerated duration of lobradimil plus carboplatin with radiotherapy in patients with newly diagnosed brain stem gliomas.
- Determine the toxic effects of this treatment regimen in these patients.
- Assess the response to radiotherapy in patients treated with this regimen.
OUTLINE: Patients receive radiotherapy for 5 consecutive days a week for 6.5 weeks, for a total of 33 doses. Patients receive carboplatin IV over 15 minutes followed by lobradimil IV over 10 minutes concurrently with radiotherapy.
The first cohort of 3-6 patients receives treatment with carboplatin and lobradimil for the first three weeks of radiotherapy, with the duration of chemotherapy increasing by one week with each subsequent cohort until the maximum duration of 6.5 weeks is reached or until unacceptable toxicity occurs in 2 of 6 patients.
Patients are followed at 6 weeks; every 3 months for 2 years; every 6 months for 3 years; and then annually thereafter.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 3 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 30 Days
干预措施: radiation therapy (Radiation)
Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 20 Days
干预措施: carboplatin (Drug)
Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 20 Days
干预措施: cereport (Drug)
Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 20 Days
干预措施: radiation therapy (Radiation)
Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 25 Days
干预措施: carboplatin (Drug)
Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 25 Days
干预措施: cereport (Drug)
Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 25 Days
干预措施: radiation therapy (Radiation)
Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 30 Days
干预措施: carboplatin (Drug)
Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 30 Days
干预措施: cereport (Drug)
Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 33 Days
干预措施: carboplatin (Drug)
Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 33 Days
干预措施: cereport (Drug)
Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 33 Days
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Progression Free Survival
A MRI scan will be performed six (6) weeks after completion of radiation, plus at three-month intervals thereafter for two years, as long as there is no evidence of progressive disease. Children who are progression-free two years after treatment will have MRI scanning at six-month intervals, thereafter, for three more years
次要结局
未报告次要终点