A Phase Ib Study With Dose Expansion Cohort of Proton Craniospinal Irradiation for Leptomeningeal Metastases From Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 8
- 主要终点
- number of patients with dose-limiting toxicity
研究概览
简要总结
The purpose of this study is to find the safest and most effective dose for delivering proton beam to the space containing CSF, brain, and spinal cord, in treating leptomeningeal metastases. The researchers think that using proton beam radiation to treat the space containing CSF, brain, and spinal cord, instead of treating only the areas where the metastasized tumor cells are causing symptoms, would improve the treatment of this disease.
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
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female subjects must either be of non-reproductive potential (i.e. post-menopausal by history: >/= 60 years old and no menses for 1> year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test within 2 weeks prior to starting treatment.
- •Patient with solid tumor malignancy with leptomeningeal metastases established radiographically and/or through CSF cytology.
- •Age ≥ 10 years.
- •For adult patient, the patient is able to provide informed consent. For pediatric patient, a parent is able to provide informed consent.
- •Patient at reproductive potential must agree to practice an effective contraceptive method.
- •Adequate bone marrow function:
- •Hemoglobin ≥ 8g/dL
- •Absolute neutrophil count ≥500/mm^3
- •Platelet count ≥ 100,000/mm^3
排除标准
- •Patient with multiple, serious major neurologic deficits including encephalopathy.
- •Patient with extensive systemic disease and without reasonable systemic treatment options.
- •Patient who is unable to undergo MRI brain and spine with gadolinium contrast.
- •Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances.
- •Pregnant or lactating women.
研究组 & 干预措施
Proton Radiation
Patients will be enrolled to receive 30Gy (RBE) in 3Gy (RBE) or 25Gy (RBE) in 2.5Gy (RBE) fractions course of proton CSI.
The first 3 patients will be enrolled at dose level 30Gy (RBE) in 3Gy(RBE) fractions. If 1 or fewer patients develop dose-limiting toxicity (DLT), 3 additional patients will be enrolled. If 1 or fewer of the 6 patients experiences a DLT, the trial will proceed to the dose expansion cohort at 30Gy (RBE) . In contrast, if 2 or more patients experience a treatment DLT, 3 patients will be enrolled at dose level 25Gy (RBE) in 2.5Gy(RBE) fractions. If 1 or fewer patients develop a DLT, an additional three patients will be enrolled. If 2 or more patients experience a DLT at 25Gy, the study will be stopped. If 1 or fewer patients develop a DLT in these 6 patients, the trial will proceed to the dose expansion cohort at 25Gy (RBE) and the 6 patients who were treated in Phase Ib will be included in full assessment of safety and efficacy.
干预措施: Proton craniospinal irradiation (CSI) (Radiation)
结局指标
主要结局
number of patients with dose-limiting toxicity
时间窗: 2 years
will be assessed by physician-graded CTCEAv4
次要结局
未报告次要终点