NCT02838342已完成2 期
Pharmaco-immunological Study of Interferon-alpha and Metronomic Cyclophosphamide Association in Neuroendocrine Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- rate of patients with an immune response defined as "Tregs lymphocytes decrease ≥ 20% in blood by the flow cytometry technique"
研究概览
简要总结
This study will evaluate the potential immunomodulatory synergy of the association of metronomic cyclophosphamide (CMC) and interferon-alpha (IFN-alpha).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •performance status ECOG-WHO ≤ 1
- •histologically proved neuroendocrine tumor with Ki67 < or = 10%, metastatic or locally advanced without surgery possibility
- •at least one measurable lesion based on RECIST criteria version 1.1
- •signed written informed consent
排除标准
- •previous treatment with interferon or cyclophosphamide
- •treatment by immunosuppressive drugs
- •diabetes complicated by coronary artery disease or vasculopathy
- •severe respiratory failure, chronic respiratory failure, COPD
- •history of severe heart failure
- •severe renal or hepatic impairment
- •diabetes complicated with coronary artery disease or vasculopathy
- •alcoholism unweaned
- •uncontrolled epilepsy and/or achievement of the central nervous system functions
- •history of severe depressive syndrome
- •presence or history of severe psychiatric condition, particularly severe depression, suicidal thoughts or attempted suicide
- •decompensated liver cirrhosis
- •severe myelosuppression
- •psoriasis and sarcoidosis
- •active disease condition or uncontrolled infection
- •association with the yellow fever vaccine
- •association with phenytoin in prophylaxis
- •hypersensitivity against interferon or cyclophosphamide
- •prior history of other malignancy except for: basal cell carcinoma of the skin, cervical intra-epithelial neoplasia and other cancer curatively treated with no evidence of disease for at least 3 years
- •pregnancy, breast-feeding or absence of adequate contraception for fertile patients
- •patients under guardianship, curatorship or under the protection of justice
研究组 & 干预措施
Metronomic cyclophosphamide and interferon-alpha
Experimental
干预措施: Metronomic cyclophosphamide (Drug)
Metronomic cyclophosphamide and interferon-alpha
Experimental
干预措施: Interferon-alpha (Drug)
结局指标
主要结局
rate of patients with an immune response defined as "Tregs lymphocytes decrease ≥ 20% in blood by the flow cytometry technique"
时间窗: at 3 months of the association CMC and Interferon-alpha
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
尚未招募
Unknown
EFFECT Trial: Evaluating Fermentable Fibre as a Long COVID TherapyACTRN12624000356561Monash University40
终止
3 期
Structured Treatment Interruptions With or Without Pegylated Interferon Alpha for HIV-Infected Patients After Prolonged Viral SuppressionHIV InfectionsNCT00125814French National Agency for Research on AIDS and Viral Hepatitis200
招募中
不适用
Characterization immuno-modulatory effects of Tecfidera: feasibility study.Tecfidera induced lymphocytopeniaNL-OMON27762ot Applicable16
终止
1 期
Study of Pegylated Alfa Interferon, Sunitinib and Tarceva in Patients With Metastatic RCCCarcinoma, Renal CellNCT00522249The Methodist Hospital Research Institute10
已完成
不适用
ipid emulsion (drug) in Acute on Chronic Liver Failure (Liver Disease).CTRI/2018/04/012995Institute of liver and Biliary Sciences90