WithdrawnPhase 2

Effect of Vorinostat on ACTH Producing Pituitary Adenomas in Cushing s Disease

Stopped: Lack of enrollment.

United States0Started 2025-04-11

Plain-language summary

Background: Cushing s disease is caused by excess ACTH hormone release by a benign tumor of the pituitary gland. It can lead to decreased quality of life and early death. The current best treatment for Cushing s disease is surgery. If surgery does not work or if the tumor returns, there are no more good treatment options. Vorinostat, which is approved to treat a type of lymphoma, might be a treatment option. Objective: To test vorinostat to see if it can kill tumor cells and change the number of hormones released in people with Cushing s disease. Eligibility: People ages 18 and older who have Cushing s disease and are scheduled for surgery under protocol 03-N-0164 to remove a tumor in their pituitary gland Design: Participants will be screened under protocol 03-N-0164. Participants will stay in the hospital for 8 days before their surgery. On the first day, participants will have a physical exam and blood tests. They will have their urine collected for testing all day. They will have an ECG: For this, small metal disks or sticky electrode pads will be placed on their chest to record heart activity. For the next 7 days, participants will have blood tests and all-day urine collection. They will drink at least 2 liters of fluid per day. They will take the study drug by mouth each morning. On the eighth day, participants will have their surgery. Leftover tissue will be collected for research. On the day they are discharged from the hospital, participants will have a physical exam and blood tests.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: * Adult patients (18 years and older) * Confirmed biochemical diagnosis of Cushing s disease (primary or recurrent) as evidenced by increased 24-hour urine free cortisol (UFC), normal or increased morning plasma Adrenocorticotropic Hormone (ACTH), and pituitary origin of excess ACTH. * Surgical candidate for resection of ACTH producing pituitary adenoma * Enrolled in 03-N-0164, Evaluation of Neurosurgical Disorders. * Able to provide written informed consent at the time of study enrollment. * Participants who are physically able to become pregnant must use an effective form of birth control from 14 days prior to enrollment through 6 months following the last dose of vorinostat. Participants who are able to father a child must use an effective form of birth control from Day 0 through 3 months following the last dose of vorinostat. EXCLUSION CRITERIA: * Patients who have been previously treated with vorinostat. * Patients who have received sellar radiation. * Significant medical illnesses that in the investigator s opinion cannot be adequately controlled or would compromise the patient s ability to tolerate this vorinostat. * Any history of cancer, unless in complete remission and off of all therapy for that disease for a minimum of 3 years. * History of thromboembolic disorder or deep vein thrombosis * Presence of abnormal hematological and bio…

What they're measuring

Midnight Plasma ACTH

Timeframe: Day -1, Day 0-1, Day 2, Day 4-6, Discharge

Trial details

NCT IDNCT04339751

SponsorNational Institute of Neurological Disorders and Stroke (NINDS)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2025-04-11