A Phase I Trial of Lenalidomide and Radiotherapy in Children With Diffuse Intrinsic Pontine Gliomas and High-grade Gliomas
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Tolerability
研究概览
简要总结
Background:
- Children who are diagnosed with brain tumors known as high grade gliomas or diffuse intrinsic pontine gliomas are generally treated with radiation therapy and chemotherapy. However, these tumors are very difficult to cure, and the tumor frequently begins to grow again even after treatment or surgery. Researchers are interested in determining whether the anticancer drug lenalidomide, which has been used to treat other aggressive types of cancer, is a safe and effective additional treatment for children who are scheduled to receive radiation therapy to treat high grade gliomas or diffuse intrinsic pontine gliomas.
Objectives:
- To determine the safety and effectiveness of lenalidomide, in conjunction with radiation therapy, as a treatment for children who have been diagnosed with high grade gliomas or diffuse intrinsic pontine gliomas.
Eligibility:
- Children and adolescents up to 21 years of age who have been diagnosed with high grade gliomas or diffuse intrinsic pontine gliomas and have not had radiotherapy or chemotherapy.
Design:
- Participants will be screened with a medical history, physical examination, blood and urine tests, and imaging studies.
- Participants will have two phases of treatment: a lenalidomide plus radiation phase and a lenalidomide-only phase.
- During the radiation phase, participants will take lenalidomide daily and have 6 weeks of radiation therapy (five treatments per week). After the radiation therapy, participants will stop taking lenalidomide for 2 weeks before continuing to the next phase.
- During the lenalidomide-only phase, participants will take lenalidomide daily for 21 days, followed by 7 days without lenalidomide (28-day cycle of treatment). Participants will have up to 24 cycles of lenalidomide.
- Participants will have frequent blood tests during the first cycle of treatment, and will have imaging studies or other tests as required by the study researchers.
- Treatment will continue until the disease progresses, the participant chooses to leave the study, or the researchers end the study.
详细描述
Background:
Brain tumors are the most common solid neoplasm in childhood and the second most common group of pediatric cancers.
Standard therapeutic options for brain tumors consist of surgical resection, radiation therapy and chemotherapy; yet overall survival rates for malignant brain tumors remain low.
Radiation therapy plays a key role in the treatment of diffuse intrinsic pontine gliomas (DIPG) and high-grade gliomas (HGG), and thalidomide has been shown in an animal model to be a radiosensitizer.
Lenalidomide, a thalidomide analog with antiangiogenic, cytotoxic and immunomodulatory effects, is being evaluated for the treatment of CNS tumors, and has shown tolerability and activity in pediatric studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 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
1
Radiation with Lenalidomide
干预措施: Lenalidomide (Drug)
1
Radiation with Lenalidomide
干预措施: XRT, 54-59.4 Gy (Radiation)
结局指标
主要结局
Tolerability
时间窗: 2 years
The plasma steady state concentration (and CSF levels if available for other reasons) will be correlated with toxicities (type and incidence), time to progression and response.
Toxicity Profile
时间窗: 2 years
We will also estimate the population parameters using nonlinear mixed effects modeling methods (NONMEM)
次要结局
- Evaluate MRI Sequences(3 years)
- Progression-free survival(4 years)
- Overall Survival(4 years)
- Pharmacokinetics correlation with progression and toxicities(3 years)
- Biomarkers & toxicity/disease response correlation(3 years)