A Pharmacokinetic and Phase II Study of Oral Cyclophosphamide and Oral Topotecan in Children With Recurrent and or Refractory Solid Tumors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Radiographic imaging
研究概览
简要总结
The purposes of this study include:
- Determination of the change in clearance of topotecan and topotecan lactone between day 1 and day 14 for patients receiving treatment with p.o. topotecan and p.o. cyclophosphamide x 14 days.
- Determination of the correlation between the activity of CYP3A4, as measured by the 14C- Erythromycin Breath Test (ERMBT), and topotecan/topotecan lactone clearance for patients receiving treatment with p.o. topotecan and p.o. cyclophosphamide x 14 days.
- Determination of the response rate to oral cyclophosphamide and oral topotecan in recurrent and/or refractory pediatric solid tumors.
- Obtain additional safety data for the chemotherapy regimen, p.o. topotecan and p.o. cyclophosphamide x 14 days.
- Report the frequency of severe toxicities associated with the level of CYP3A4 activity, as measured by the ERMBT, for patients receiving treatment with p.o. topotecan and p.o. cyclophosphamide x 14 days.
详细描述
Upon obtaining informed consent, patients will begin two courses of oral cyclophosphamide and topotecan x 14 days. During the first of two courses, patients will perform the 14C-Erythromycin Breath Test and have topotecan pharmacokinetics performed on day 1 and 14. The subjects will also have various medical tests and procedures performed that are part of regular cancer care which include: Medical history and physical examination to be done weekly, blood tests to be done weekly, heart and kidney function tests, various scans to be done after two courses of treatment, and a pregnancy test for females of childbearing age to be done prior to starting treatment.
Patients may continue to receive additional courses of oral cyclophosphamide and topotecan provided that they do not experience tumor progression or intolerable side effects.
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
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be less than 22 years of age inclusive
- •Tumor histologies: medulloblastoma/PNET, neuroblastoma, sarcomas, and other pediatric solid tumors for which there is no known effective therapy.
- •Patients must have measurable disease, documented by clinical, radiographic, or histologic criteria.
- •Patients must have a performance status of 0, 1 or
- •Use Karnofsky for patients > 16 years of age and Lansky for patients <= 16 years of age.
- •Patients must have a life expectancy of >= 8 weeks.
- •Prior Therapy: Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
- •Patients must not be taking the following medications: growth factors, steroids, and CYP3A4 inducers or inhibitors.
- •Patients must have adequate bone marrow, renal, liver function, pulmonary, or central nervous system function.
- •Must be able and willing to participate in all study procedures, including the ERMBT and pharmacokinetic studies.
- •All patients and/or their parents or legal guardians must sign a written informed consent. (11) All institutional, FDA, and NCI requirements for human studies must be met.
排除标准
- •Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
- •Patients with an uncontrolled infection.
- •Allergy to erythromycin
- •Patients who have previously received either cyclophosphamide or topotecan are eligible for this study.
研究组 & 干预措施
1
干预措施: Cyclophosphamide and Topotecan (Drug)
结局指标
主要结局
Radiographic imaging
时间窗: Every 2 cycles
次要结局
未报告次要终点