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Histone Deacetylase Inhibitor
Vorinostat for Uveal Melanoma
Phase 2
Waitlist Available
Led By Alexander N Shoushtari
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
No Placebo-Only Group
Summary
This trial looks at vorinostat as a treatment for melanoma that has spread to other parts of the body. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Who is the study for?
Adults with metastatic uveal melanoma (eye melanoma that has spread) can join this trial. They must have measurable disease, acceptable organ function tests, and a life expectancy over 3 months. Participants need to agree to use contraception and cannot be pregnant or breastfeeding. Those with certain serious health conditions or taking specific medications are excluded.
What is being tested?
The trial is testing Vorinostat's effectiveness in treating metastatic uveal melanoma by inhibiting enzymes needed for tumor cell growth. It includes laboratory biomarker analysis to monitor the response and requires prior progression on other therapies.
What are the potential side effects?
Vorinostat may cause side effects such as fatigue, digestive issues, changes in blood counts leading to increased infection risk, and potential harm to an unborn child; hence contraception is required during the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall response rate in patients with uveal melanoma
Secondary study objectives
Incidence of toxicities
Overall survival
Progression free survival
Other study objectives
BAP1 mutation status
GNA11 mutation status
Gnaq mutation status
Side effects data
From 2011 Phase 3 trial • 661 Patients • NCT0012810257%
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%
Bladder cancer
1%
Overdose
1%
Sepsis
1%
Pneumothorax
1%
Confusional state
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: Treatment (vorinostat)Experimental Treatment2 Interventions
Patients receive vorinostat PO BID for 3 days weekly for 4 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
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 Cancer Institute (NCI)Lead Sponsor
13,886 Previous Clinical Trials
41,020,897 Total Patients Enrolled
Institut Curie ParisUNKNOWN
Memorial Sloan Kettering Cancer CenterOTHER
1,964 Previous Clinical Trials
596,911 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have tried other treatments before. You need to wait at least 3 weeks after your last treatment, and 6 weeks if the last treatment included specific drugs. Your doctor thinks your disease got worse after the last treatment.You have had allergic reactions to drugs similar to vorinostat.You are currently being treated for another type of cancer.You have a low level of white blood cells.You have ongoing severe nausea and vomiting, long-term stomach or intestine problems, or have had a major surgery on your intestines that affects how your body absorbs food and medicine.Your heart's QT interval is longer than 475 milliseconds.You have brain metastases that are currently growing or have not been treated yet. If you have been treated for brain metastases, they must have been stable for at least 2 months.People with HIV who are taking medication for it can join the study, unless their CD4 count is very low.You have difficulty swallowing pills.You need to have a certain number of a type of white blood cell called neutrophils in your blood.You are not currently taking certain medications that affect gene activity, or you have stopped taking them for at least 14 days.Pregnant women and breastfeeding mothers should not participate in this study because the study drug vorinostat may harm the baby.You must have advanced uveal melanoma that has been confirmed by a doctor through either a tissue sample or clinical evaluation. If a tissue sample is not available, the diagnosis can be confirmed through standard clinical practice. Confirmation of diagnosis may also be done at specific medical centers.Your AST and ALT levels in the blood should not be too high, unless you have liver metastases, in which case they can be a little higher.Patients must have a detectable disease according to specific guidelines.You must be able to perform daily activities with only a little help.You are expected to live for more than 3 months.Your platelet count is at least 100,000 per microliter.Your hemoglobin level is at least 9.0 grams per deciliter and you haven't needed a blood transfusion in the last 2 weeks.Your total bilirubin level needs to be within a certain range, unless you have a condition called Gilbert's syndrome.Your creatinine level in your blood is not higher than 1.5 mg/dL.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (vorinostat)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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