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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Study ID
NCT04339751
Phase
PHASE2
Status
Withdrawn

Conditions

  • Cushing's Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Apr 11, 2025
Status verified
Apr 2025
Primary completion
Apr 11, 2025
Completion
Apr 11, 2025

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: single center, prospective pilot study
    effectiveness of vorinostat to reduce midnight ACTH levels in patients with Cushing s Disease

Primary Outcome Measure

Midnight Plasma ACTH [ Time Frame: Day -1, Day 0-1, Day 2, Day 4-6, Discharge ]

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892-

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By research site
National Institutes of Health Clinical Center· Bethesda, MD

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