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Histone Deacetylase Inhibitor

Vorinostat for Cushing's Disease

Phase 2

Recruiting

Led By Prashant Chittiboina, M.D.

Research Sponsored by National Institute of Neurological Disorders and Stroke (NINDS)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day -1, day 0-1, day 2, day 4-6, discharge

Awards & highlights

Study Summary

This trial is testing vorinostat to see if it can kill tumor cells and change the number of hormones released in people with Cushing's disease.

Who is the study for?

This trial is for adults over 18 with Cushing's disease who are scheduled for pituitary tumor surgery. They must be able to use effective birth control, have not had radiation on the sellar region, no history of cancer in the last 3 years, and cannot have been treated with vorinostat before. Participants should not have significant illnesses that could affect their participation or serious blood count abnormalities.Check my eligibility

What is being tested?

The trial tests Vorinostat's effectiveness on ACTH-producing pituitary adenomas in patients with Cushing’s disease. It involves an 8-day hospital stay where participants take Vorinostat orally before undergoing surgery to remove the tumor, alongside regular physical exams, blood tests, and urine collection.See study design

What are the potential side effects?

Potential side effects of Vorinostat may include fatigue, digestive issues like nausea or diarrhea, changes in blood counts leading to increased risk of infections or bleeding problems. There might also be a risk of deep vein thrombosis (blood clots) and allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with Cushing's disease, confirmed by specific hormone tests.

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I am eligible for surgery to remove a tumor in my pituitary gland causing ACTH production.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day -1, day 0-1, day 2, day 4-6, discharge

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day -1, day 0-1, day 2, day 4-6, discharge

This trial's timeline: 3 weeks for screening, Varies for treatment, and day -1, day 0-1, day 2, day 4-6, discharge for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Midnight Plasma ACTH

Secondary outcome measures

Urinary Free Cortisol

Side effects data

From 2011 Phase 3 trial • 661 Patients • NCT00128102

57%

Nausea

47%

Fatigue

43%

Diarrhoea

40%

Decreased appetite

40%

Vomiting

29%

Dyspnoea

24%

Constipation

20%

Weight decreased

18%

Tumour pain

18%

Cough

15%

Pleural mesothelioma malignant advanced

14%

Anaemia

12%

Pyrexia

Insomnia

Dry mouth

Blood creatinine increased

Abdominal pain

Back pain

Dysgeusia

Dizziness

Oedema peripheral

Thrombocytopenia

Headache

C-reactive protein increased

Dehydration

Musculoskeletal pain

Malaise

Pneumonia

Anxiety

Rash

Atrial fibrillation

Accidental overdose

Pleural effusion

Sepsis

Overdose

Bladder cancer

Pneumothorax

Non-cardiac chest pain

Confusional state

General physical health deterioration

Pericarditis

Disseminated intravascular coagulation

Death

Ascites

Dysphagia

Pulmonary embolism

Deep vein thrombosis

100%

80%

60%

40%

20%

Study treatment Arm

Vorinostat

Placebo

Trial Design

1Treatment groups

Experimental Treatment

Group I: single center, prospective pilot studyExperimental Treatment1 Intervention

effectiveness of vorinostat to reduce midnight ACTH levels in patients with Cushing s Disease

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vorinostat

2014

Completed Phase 3

~1600

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)Lead Sponsor

1,340 Previous Clinical Trials

649,337 Total Patients Enrolled

1 Trials studying Cushing's Disease

22 Patients Enrolled for Cushing's Disease

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

6 Previous Clinical Trials

648 Total Patients Enrolled

1 Trials studying Cushing's Disease

22 Patients Enrolled for Cushing's Disease

Media Library

Vorinostat (Histone Deacetylase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04339751 — Phase 2

Cushing's Disease Research Study Groups: single center, prospective pilot study

Cushing's Disease Clinical Trial 2023: Vorinostat Highlights & Side Effects. Trial Name: NCT04339751 — Phase 2

Vorinostat (Histone Deacetylase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04339751 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an open call for participants in this clinical experiment?

"Per the clinicaltrials.gov registry, enrollment for this particular trial has closed as of November 30th 2022. Despite the end of recruitment, there are still 120 other medical studies recruiting participants currently."

Answered by AI

Has the FDA sanctioned Vorinostat for therapeutic use?

"After a thorough evaluation, our team at Power has concluded that Vorinostat is likely safe and awarded it a score of 2. This assessment was based on the fact that this trial is currently in Phase 2, which means there are some safety data but no efficacy-related information available yet."

Answered by AI

Are there any additional research papers published on the efficacy of Vorinostat?

"At the moment, Vorinostat is being investigated for research purposes in 32 active clinical trials with 2 of them at Phase 3. The primary location where this analysis is taking place is Bethesda, Maryland; yet there are also 798 other sites involved in the studies surrounding Vorinostat."

Answered by AI

What is the total participant count for this research endeavor?

"At the present moment, this trial is not open to new participants. The posting was initially published on December 6th 2022 and further edited on November 30th 2022. However, there are 88 potential studies for Cushing's Disease and 32 trials recruiting patients for Vorinostat underway at the current time."

Answered by AI

Recent research and studies

Obesity ResearchJournal

The Basophil Adenomas of the Pituitary Body and Their Clinical Manifestations (pituitary Basophilism)<sup>1</sup>

Cushing, Harvey. 1994. “The Basophil Adenomas of the Pituitary Body and Their Clinical Manifestations (pituitary Basophilism)1”. Obesity Research. Wiley. doi:10.1002/j.1550-8528.1994.tb00097.x.

The LancetJournal

Cushing's Syndrome

Newell-Price, John, Xavier Bertagna, Ashley B Grossman, and Lynnette K Nieman. 2006. “Cushing's Syndrome”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(06)68699-6.

The Journal of Clinical Endocrinology & MetabolismJournal

Diagnosis and Complications of Cushing’s Syndrome: A Consensus Statement

Arnaldi, G., A. Angeli, A. B. Atkinson, X. Bertagna, F. Cavagnini, G. P. Chrousos, G. A. Fava, et al.. 2003. “Diagnosis and Complications of Cushing’s Syndrome: A Consensus Statement”. The Journal of Clinical Endocrinology & Metabolism. The Endocrine Society. doi:10.1210/jc.2003-030871.

clinicaltrials.govStudy