Effect of Vorinostat on ACTH Producing Pituitary Adenomas in Cushing s Disease
Status:
Not yet recruiting
Trial end date:
2023-06-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)