The Effect of Combined Treatment of Cabergoline With Hydroxychloroquine/Chloroquine for Resistant Prolactinomas
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 9
- 主要终点
- Change from baseline on prolactin(PRL) level
研究概览
简要总结
The purpose of this study is to preliminarily evaluate the safety and efficacy of cabergoline combined hydroxychloroquine/chloroquine(HCQ/CQ) therapy for cabergoline-Resistant Prolactinomas
详细描述
The dopamine agonist cabergoline (CAB) has been used widely in the treatment of prolactinomas, but its clinical use is hampered by intolerance and/or resistant in some patients with prolactinoma. Chloroquine (CQ) is an old drug widely used to treat malaria. Recent studies, including our own (J Clin Endocrinol Metab, 2017; Autophagy, 2017; Oncotarget, 2015), have revealed that CAB and CQ are involved in induction of autophagy and activation of autophagic cell death. Furthermore, CQ enhanced suppression of cell proliferation by CAB. We established a low-CAB-dose condition in which CAB was able to induce autophagy but failed to suppress cell growth. Addition of CQ to low-dose CAB blocked normal autophagic cycles and induced apoptosis, evidenced by the further accumulation of p62/caspase-8/LC3-II. The data suggest that combined use of CAB and CQ may increase clinical effectiveness in treatment of intolerance and/or resistant prolactinomas.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 70 years old, either sex;
- •Karnofsky performance status ≥ 70;
- •Patients who were suffered drug-resistant,which has taken cabergoline ≥2.0mg/week no less than 3 months, referring to failure to normalize PRL levels and failure to decrease macroprolactinoma size by >or=50%;
- •The patient has signed the informed consent.
排除标准
- •Patients concomitantly taking the psychotropic drugs or other drugs causing elevated PRL ;
- •Patients with parkinson disease and is taking dopaminergic agents;
- •Patients with prolactinoma who received Gamma knife treatment;
- •Patients who use any dopamine receptor agonists other than cabergoline;
- •pregnant or lactating women, or women preparing pregnant;
- •Patients with poor compliance, who cannot implement the program strictly.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to HCQ.
- •Glucose-6-phosphate dehydrogenase (G6PD) deficiency, as HCQ may cause hemolytic anemia in patients with G6PD deficiency.
研究组 & 干预措施
HCQ/CQ and CAB combined treatment
Subjects are treated with hydroxychloroquine sulfate tablets 5mg/kg Bid and cabergoline tablets 2mg/week for 3 months.
干预措施: HCQ/CQ and CAB combined treatment (Drug)
结局指标
主要结局
Change from baseline on prolactin(PRL) level
时间窗: Up to 6 months
Record the result of prolactin on every 3 month follow-up visit
次要结局
- Change from baseline of visual acuity(Up to 6 months)
- Change from baseline on tumor volume measured by enhanced pituitary Magnetic Resonance Imaging（MRI）(Up to 6 months)
- Change from baseline on 5 point visual field scale(Up to 6 months)
研究者
Zhebao Wu
Chief Physician
Ruijin Hospital