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Trial record 11 of 13 for:    "Adenoma" | "Cabergoline"

Cabergoline Combined Hydroxychloroquine/Chloroquine to Treat Resistant Prolactinomas

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ClinicalTrials.gov Identifier: NCT03400865
Recruitment Status : Not yet recruiting
First Posted : January 17, 2018
Last Update Posted : October 16, 2018
Sponsor:
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
Information provided by (Responsible Party):
Zhebao Wu, Ruijin Hospital

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

Condition or disease Intervention/treatment Phase
Resistance, Disease Prolactinoma Drug: HCQ/CQ and CAB combined treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Combined Treatment of Cabergoline With Hydroxychloroquine/Chloroquine for Resistant Prolactinomas
Estimated Study Start Date : October 25, 2018
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2020


Arm Intervention/treatment
Experimental: HCQ/CQ and CAB combined treatment
Subjects are treated with hydroxychloroquine sulfate tablets 5mg/kg Bid and cabergoline tablets 2mg/week for 3 months.
Drug: HCQ/CQ and CAB combined treatment
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.
Other Name: HCCT




Primary Outcome Measures :
  1. Change from baseline on prolactin(PRL) level [ Time Frame: Up to 6 months ]
    Record the result of prolactin on every 3 month follow-up visit


Secondary Outcome Measures :
  1. Change from baseline on tumor volume measured by enhanced pituitary Magnetic Resonance Imaging(MRI) [ Time Frame: Up to 6 months ]
    Record the tumor volume from enhanced pituitary MRI on every 3 month follow-up visits

  2. Change from baseline of visual acuity [ Time Frame: Up to 6 months ]
    Record the Visual acuity on every 3 month follow-up visit

  3. Change from baseline on 5 point visual field scale [ Time Frame: Up to 6 months ]
    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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged between 18 and 70 years old, either sex;
  2. Karnofsky performance status ≥ 70;
  3. 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%;
  4. The patient has signed the informed consent.

Exclusion Criteria:

  1. Patients concomitantly taking the psychotropic drugs or other drugs causing elevated PRL ;
  2. Patients with parkinson disease and is taking dopaminergic agents;
  3. Patients with prolactinoma who received Gamma knife treatment;
  4. Patients who use any dopamine receptor agonists other than cabergoline;
  5. pregnant or lactating women, or women preparing pregnant;
  6. Patients with poor compliance, who cannot implement the program strictly.
  7. History of allergic reactions attributed to compounds of similar chemical or biologic composition to HCQ.
  8. Glucose-6-phosphate dehydrogenase (G6PD) deficiency, as HCQ may cause hemolytic anemia in patients with G6PD deficiency.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03400865


Contacts
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Contact: Shaojian Lin, MD 0086-15801782758 shaojianlin88@126.com
Contact: Zhebao Wu, Medical PhD 0086-021-64370045 zhebaowu@aliyun.com

Locations
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China, Beijing
Beijing Tiantan Hospital Not yet recruiting
Beijing, Beijing, China
China, Shanghai
Huashan Hospital Not yet recruiting
Shanghai, Shanghai, China, 200025
Ruijin Hosipital Enrolling by invitation
Shanghai, Shanghai, China, 200025
China
Chinese PLA General Hospital Not yet recruiting
Beijing, China
Peking Union Medical College Hospital Recruiting
Beijing, China
Xinqiao Hospital of Chongqing Not yet recruiting
Chongqing, China
First Affiliated Hospital of Fujian Medical Recruiting
Fujian, China
First Hospital of China Medical University Not yet recruiting
Shenyang, China
First Affiliated Hospital of Wenzhou Medical Univeristy Recruiting
Wenzhou, China
Sponsors and Collaborators
Zhebao Wu
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
Investigators
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Study Chair: Zhebao Wu, Medical Ruijin Hospital

Publications of Results:
Other Publications:
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Responsible Party: Zhebao Wu, Chief Physician, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT03400865     History of Changes
Other Study ID Numbers: HCCT-2018
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhebao Wu, Ruijin Hospital:
cabergoline
prolactinomas
resistant
hydroxychloroquine
chloroquine
Additional relevant MeSH terms:
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Adenoma
Cabergoline
Prolactinoma
Disease Resistance
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pituitary Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Disease Attributes
Pathologic Processes
Hydroxychloroquine
Chloroquine
Chloroquine diphosphate
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents
Amebicides
Anti-Inflammatory Agents, Non-Steroidal