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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
Must not have
History of thromboembolic disorder or deep vein thrombosis
Patients who have received sellar radiation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day -1, day 0-1, day 2, day 4-6, discharge
Awards & highlights
No Placebo-Only Group

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.
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.
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
Select...
I have been diagnosed with Cushing's disease, confirmed by specific hormone tests.
Select...
I am eligible for surgery to remove a tumor in my pituitary gland causing ACTH production.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had blood clots or deep vein thrombosis in the past.
Select...
I have undergone radiation therapy targeting the pituitary gland area.
Select...
I have been cancer-free and off treatment for at least 3 years.
Select...
I have been treated with vorinostat before.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Midnight Plasma ACTH
Secondary study objectives
Urinary Free Cortisol

Side effects data

From 2011 Phase 3 trial • 661 Patients • NCT00128102
57%
Nausea
47%
Fatigue
43%
Diarrhoea
40%
Vomiting
40%
Decreased appetite
29%
Dyspnoea
24%
Constipation
20%
Weight decreased
18%
Tumour pain
18%
Cough
15%
Pleural mesothelioma malignant advanced
14%
Anaemia
12%
Pyrexia
9%
Insomnia
9%
Dry mouth
9%
Blood creatinine increased
9%
Abdominal pain
8%
Back pain
8%
Dysgeusia
7%
Oedema peripheral
7%
Dizziness
7%
Thrombocytopenia
7%
Headache
6%
C-reactive protein increased
6%
Dehydration
6%
Musculoskeletal pain
5%
Malaise
4%
Pneumonia
4%
Anxiety
3%
Rash
2%
Atrial fibrillation
2%
Accidental overdose
2%
Pleural effusion
1%
Overdose
1%
Sepsis
1%
Pneumothorax
1%
Confusional state
1%
Bladder cancer
1%
General physical health deterioration
1%
Non-cardiac chest pain
1%
Pericarditis
1%
Disseminated intravascular coagulation
1%
Death
1%
Ascites
1%
Dysphagia
1%
Pulmonary embolism
1%
Deep vein thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vorinostat
Placebo

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)Lead Sponsor
1,380 Previous Clinical Trials
652,161 Total Patients Enrolled
Prashant Chittiboina, M.D.Principal InvestigatorNational Institute of Neurological Disorders and Stroke (NINDS)
6 Previous Clinical Trials
648 Total Patients Enrolled

Media Library

Vorinostat (Histone Deacetylase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04339751 — Phase 2
Hypercortisolism Research Study Groups: single center, prospective pilot study
Hypercortisolism 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
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