Resistance, DiseaseNCT03400865
Cabergoline Combined Hydroxychloroquine/Chloroquine to Treat Resistant Prolactinomas
A study testing HCQ/CQ and CAB combined treatment in people with Resistance, Disease and Prolactinoma, run by Zhebao Wu at 9 sites in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Resistance, Disease, Prolactinoma
- What is being tested?
- HCQ/CQ and CAB combined treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 9 sitesChina
- Study dates
- 25 Oct 2018to 30 Dec 2020
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
Beijing Tiantan Hospital
Beijing, Beijing Municipality
Chinese PLA General Hospital
Beijing
Peking Union Medical College Hospital
Beijing
Xinqiao Hospital of Chongqing
Chongqing
First Affiliated Hospital of Fujian Medical
Fujian
Huashan Hospital
Shanghai, Shanghai Municipality, 200025
Ruijin Hosipital
Shanghai, Shanghai Municipality, 200025
First Hospital of China Medical University
Shenyang
First Affiliated Hospital of Wenzhou Medical Univeristy
Wenzhou
About this study
Official title: The Effect of Combined Treatment of Cabergoline With Hydroxychloroquine/Chloroquine for Resistant Prolactinomas
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
Read the detailed description
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.
- Conditions
- Resistance, Disease, Prolactinoma
- Being tested
- HCQ/CQ and CAB combined treatment
- Keywords
- cabergoline, prolactinomas, resistant, hydroxychloroquine, chloroquine
- Medical subject headings
- Disease Resistance, Prolactinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCQ/CQ and CAB combined treatmentDrug
Also called HCCT
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.
| Study group | Role | What they receive |
|---|---|---|
| HCQ/CQ and CAB combined treatment | Experimental | Subjects are treated with hydroxychloroquine sulfate tablets 5mg/kg Bid and cabergoline tablets 2mg/week for 3 months. Receives: Drug: HCQ/CQ and CAB combined treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline on prolactin(PRL) level
Record the result of prolactin on every 3 month follow-up visit
Measured: Up to 6 months
Secondary outcomes (3)
Change from baseline on tumor volume measured by enhanced pituitary Magnetic Resonance Imaging（MRI）
Record the tumor volume from enhanced pituitary MRI on every 3 month follow-up visits
Measured: Up to 6 months
Change from baseline of visual acuity
Record the Visual acuity on every 3 month follow-up visit
Measured: Up to 6 months
Change from baseline on 5 point visual field scale
Record the Visual field scale on every 3 month follow-up visit, 0 = normal, no vision loss; 1 = one quadrant vision loss; 2 = two quadrants of vision loss; 3 = three quadrants of vision loss; 4 = four quadrants of vision loss but retain a central tubular vision; 5 = blind
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start25 Oct 2018 (estimated)
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Resistance, DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhebao Wu
- Sponsor type
- University, hospital or other
- Collaborators
- Xinqiao Hospital of Chongqing, First Hospital of China Medical University, Beijing Tiantan Hospital, First Affiliated Hospital of Wenzhou Medical University, First Affiliated Hospital of Fujian Medical University, Peking Union Medical College Hospital, Huashan Hospital, Chinese PLA General Hospital
- Responsible party
- Sponsor-investigator, Zhebao Wu, Ruijin Hospital
- Investigators
- Zhebao Wu, Medical, Study chair, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03400865
- Sponsor's protocol ID
- HCCT-2018
- Status last verified
- Jan 2018
- First submitted
- 8 Jan 2018
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The individual patient Data would not be shared to the third facility, but the sponsor hasn't decided whether to share the individual patient date to the other related studies hold by himself in the future.
Publications
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.
PubMed 28613975Lin 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.
PubMed 26513171Lin 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.
PubMed 28973192