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Protocol Details

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

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

20-N-0019

Sponsoring Institute

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Recruitment has not started
Gender: Male & Female
Min Age: 18
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

SAHA;
CD

Recruitment Keyword(s)

None

Condition(s)

Cushing's Disease

Investigational Drug(s)

Zolinza

Investigational Device(s)

None

Intervention(s)

Drug: Vorinostat

Supporting Site

National Institute of Neurological Disorders and Stroke

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.

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Eligibility

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


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Citations:

Arnaldi G, Angeli A, Atkinson AB, Bertagna X, Cavagnini F, Chrousos GP, Fava GA, Findling JW, Gaillard RC, Grossman AB, Kola B, Lacroix A, Mancini T, Mantero F, Newell-Price J, Nieman LK, Sonino N, Vance ML, Giustina A, Boscaro M. Diagnosis and complications of Cushing's syndrome: a consensus statement. J Clin Endocrinol Metab. 2003 Dec;88(12):5593-602.

Cushing H. The basophil adenomas of the pituitary body and their clinical manifestations (pituitary basophilism). 1932. Obes Res. 1994 Sep;2(5):486-508.

Newell-Price J, Bertagna X, Grossman AB, Nieman LK. Cushing's syndrome. Lancet. 2006 May 13;367(9522):1605-17.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Prashant Chittiboina, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)



Gretchen C. Scott, R.N.
National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health
Building 10
Room 3D20
10 Center Drive
Bethesda, Maryland 20892
(301) 496-2921
gretchen.scott@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT04339751

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