Cabergoline Combined Hydroxychloroquine/Chloroquine to Treat Resistant Prolactinomas
The Effect of Combined Treatment of Cabergoline With Hydroxychloroquine/Chloroquine for Resistant Prolactinomas
1 other identifier
interventional
30
1 country
9
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2018
Typical duration for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 8, 2018
CompletedFirst Posted
Study publicly available on registry
January 17, 2018
CompletedStudy Start
First participant enrolled
October 25, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2020
CompletedOctober 16, 2018
January 1, 2018
2.2 years
January 8, 2018
October 14, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline on prolactin(PRL) level
Record the result of prolactin on every 3 month follow-up visit
Up to 6 months
Secondary Outcomes (3)
Change from baseline on tumor volume measured by enhanced pituitary Magnetic Resonance Imaging（MRI）
Up to 6 months
Change from baseline of visual acuity
Up to 6 months
Change from baseline on 5 point visual field scale
Up to 6 months
Study Arms (1)
HCQ/CQ and CAB combined treatment
EXPERIMENTALSubjects are treated with hydroxychloroquine sulfate tablets 5mg/kg Bid and cabergoline tablets 2mg/week for 3 months.
Interventions
Subjects are treated with hydroxychloroquine sulfate tablets 5mg/kg Bid and cabergoline tablets 2mg/week for 3 months.After therapy of 3 months the medication will be stopped if does not reduce prl level more than 20% or failure to decrease prolactinoma size.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhebao Wulead
- Xinqiao Hospital of Chongqingcollaborator
- First Hospital of China Medical Universitycollaborator
- Beijing Tiantan Hospitalcollaborator
- First Affiliated Hospital of Wenzhou Medical Universitycollaborator
- First Affiliated Hospital of Fujian Medical Universitycollaborator
- Peking Union Medical College Hospitalcollaborator
- Huashan Hospitalcollaborator
- Chinese PLA General Hospitalcollaborator
Study Sites (9)
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
Huashan Hospital
Shanghai, Shanghai Municipality, 200025, China
Ruijin Hosipital
Shanghai, Shanghai Municipality, 200025, China
Chinese PLA General Hospital
Beijing, China
Peking Union Medical College Hospital
Beijing, China
Xinqiao Hospital of Chongqing
Chongqing, China
First Affiliated Hospital of Fujian Medical
Fujian, China
First Hospital of China Medical University
Shenyang, China
First Affiliated Hospital of Wenzhou Medical Univeristy
Wenzhou, China
Related Publications (3)
Leng ZG, Lin SJ, Wu ZR, Guo YH, Cai L, Shang HB, Tang H, Xue YJ, Lou MQ, Zhao W, Le WD, Zhao WG, Zhang X, Wu ZB. Activation of DRD5 (dopamine receptor D5) inhibits tumor growth by autophagic cell death. Autophagy. 2017 Aug 3;13(8):1404-1419. doi: 10.1080/15548627.2017.1328347. Epub 2017 Jun 14.
PMID: 28613975BACKGROUNDLin SJ, Leng ZG, Guo YH, Cai L, Cai Y, Li N, Shang HB, Le WD, Zhao WG, Wu ZB. Suppression of mTOR pathway and induction of autophagy-dependent cell death by cabergoline. Oncotarget. 2015 Nov 17;6(36):39329-41. doi: 10.18632/oncotarget.5744.
PMID: 26513171BACKGROUNDLin SJ, Wu ZR, Cao L, Zhang Y, Leng ZG, Guo YH, Shang HB, Zhao WG, Zhang X, Wu ZB. Pituitary Tumor Suppression by Combination of Cabergoline and Chloroquine. J Clin Endocrinol Metab. 2017 Oct 1;102(10):3692-3703. doi: 10.1210/jc.2017-00627.
PMID: 28973192RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Zhebao Wu, Medical
Ruijin Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Chief Physician
Study Record Dates
First Submitted
January 8, 2018
First Posted
January 17, 2018
Study Start
October 25, 2018
Primary Completion
December 30, 2020
Study Completion
December 30, 2020
Last Updated
October 16, 2018
Record last verified: 2018-01