Status:
WITHDRAWN
Effect of Vorinostat on ACTH Producing Pituitary Adenomas in Cushing s Disease
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Cushing's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 f...
Detailed Description
Study Description This is a single center, prospective pilot study of effectiveness of vorinostat to reduce midnight ACTH levels in patients with Cushing s Disease. Surgery for resection of ACTH prod...
Eligibility Criteria
Inclusion
- 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 biochemical parameters, (such as anemia or thrombocytopenia) as defined as:
- Neutrophil count \< 1.5 K//micro L
- Hemoglobin \< 8.0 g/dL.
- Hematocrit \< 0.75x LLN (lower limit of normal)
- RBC count \< 0.75x LLN
- Platelet count \< 100 x 10\^3 cells/micro L.
- Prothrombin time-international normalized ratio (PT-INR) \> 1.5x ULN or Activated partial thromboplastin time (aPTT) \> 1.5x ULN, with the exception of patients on prophylactic anticoagulation therapy
- Serum bilirubin level \> 1.5x ULN.
- Active infection being currently treated with systemic antibiotics.
- Serious concurrent medical illness including renal failure (creatinine \>3.0x - 6.0x ULN) liver failure (ALT/AST \>5.0x - 20.0x ULN) or severe cardio-respiratory disease.
- Pregnancy or lactation.
- Presence of any disease that will obscure toxicity or dangerously alter drug metabolism (such as uncontrolled diabetes or bleeding disorders)
- Currently receiving other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to vorinostat, such as valproate.
- Currently taking another HDACi, such as valproate.
- Currently taking coumadin or its derivative anticoagulants.
- Currently taking any other medication to reduce cortisol or ACTH levels
Exclusion
Key Trial Info
Start Date :
April 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 11 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04339751
Start Date
April 11 2025
End Date
April 11 2025
Last Update
April 15 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892