A Phase II Clinical Trial Using Metronomic Oral Low-dose Cyclophosphamide Alternating With Low-dose Oral Methotrexate With Continuous Celecoxib and Weekly Vinblastine in Children and Adolescents With Relapsed or Progressing Solid Tumours.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Anti-tumour efficacy
研究概览
简要总结
To establish the anti-tumour effect of this metronomic combination regimen defined by progression-free survival (PFS) after two cycles of treatment (4 months) and 12 months of treatment, as well as response rate after any number of cycles of treatment ("best response").
To define the safety profile of the combination. To characterize pharmacodynamics of the drug combination with the use of angiogenic markers (CEP, CEC, microparticles).
详细描述
Multi-center, combination phase II study, open-label, non-comparative, non-randomized.
All progressive or recurrent solid tumours will be included in the Phase II study, provided there are no curative options anymore.
Total expected number of patients (minimum maximum): 54 to 90 (2-stage design)
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
- 4 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have a histologically or cytologically confirmed malignant solid tumour.
- •Progression or recurrence of the tumour radiologically established or confirmed within the 4 weeks prior to inclusion.
- •Disease must be considered refractory to any line of conventional therapy or for which no effective conventional treatment exists.
- •Age: ≥4 to 21 years of age at study entry
- •Life expectancy: at least 8 weeks
- •ECOG Performance status ≤ 1 or Lansky-Play Scale ≥ 70%
- •Written informed consent of parent/guardian and patient assent
- •Wash out of 4 weeks in case of prior chemotherapy, 6 weeks if treatment included nitrosoureas, 2 weeks in case of vincristine alone; 6 weeks in case of prior radiotherapy (except palliative radiotherapy on non measurable lesions).
- •Patients must have recovered from the acute toxic effects of all prior therapy before enrolment into the study
- •Able to comply with scheduled follow-up and with management of toxicity
- •All patients with reproductive potential must practice an effective method of birth control while on study.
- •Female patients aged > 12 years must have a negative pregnancy test within 7 days before study treatment.
- •Capable of swallowing oral medication
排除标准
- •Pregnant and breast feeding women.
- •Uncontrolled intercurrent illness or active infection
- •Inability to swallow oral medication.
- •Patients on anticonvulsants will be allowed on study
研究组 & 干预措施
traetment
干预措施: celecoxib, Vinblastine, Cyclophosphamide , methotrexate , (Drug)
结局指标
主要结局
Anti-tumour efficacy
时间窗: 3 YEARS
次要结局
- Safety AND Pharmacodynamic Study(3 YEARS)