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Vorinostat for Uveal Melanoma
Study 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.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2011 Phase 3 trial • 661 Patients • NCT00128102Trial Design
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- 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.
- Group 1: Treatment (vorinostat)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
What is the maximum capacity for this clinical trial?
"This trial is not taking any more patients at the moment. The study was first posted on April 20th, 2012 and was last updated on June 29th, 2022. Currently, there are 784 other trials actively recruiting ulnar-mammary syndrome patients and 34 for Vorinostat."
What does the existing research say about Vorinostat's effectiveness?
"Vorinostat was first investigated in 2005 at the National Cancer Institute Neuro-Oncology Branch. Since that time, 698 similar studies have completed. Currently, there are 34 active trials, a great number of which are based in Nashville, Tennessee."
Are there any available positions for participants in this clinical trial?
"Unfortunately, this study is not currently enrolling patients. However, there are 784 other trials related to ulnar-mammary syndrome and 34 for Vorinostat that are open for recruitment."
What is the Vorinostat's official stance from the FDA?
"Vorinostat's safety is rated at a 2 because, while there are some studies affirming its safety, there is no data yet confirming its efficacy in humans."
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