Study on Quisinostat for Preventing Spread of High-Risk Uveal Melanoma
Sponsor: University of Miami
Sponsor score: 40
ClinicalTrials ID:NCT06932757
This clinical trial is exploring whether the drug quisinostat can help prevent the spread of uveal melanoma, a type of eye cancer, in patients who are at high risk. Researchers aim to understand the effects of quisinostat on this condition.
Patient Parameters
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Program Overview
The purpose of this study is to find out if quisinostat can stop uveal melanoma, a type of eye cancer, from spreading in patients who are considered high-risk. The researchers want to see how quisinostat affects the condition and if it can be a helpful treatment option.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with uveal melanoma with a tumor size of at least 12 mm, as determined by a doctor using methods like ultrasound or eye examination.
- Completed main treatment for uveal melanoma within the last 183 days.
- Classified as high-risk (class 2) based on specific genetic testing.
- No signs of cancer spreading to other parts of the body.
- Aged over 18 years.
- In good general health, with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Expected to live for more than 3 months.
- Able to swallow pills and have no major digestive issues that could affect medication absorption.
- Have good organ and bone marrow function as determined by blood tests.
- Women who can become pregnant and men must agree to use effective birth control during the study and for 6 months after finishing quisinostat treatment. Women must have a negative pregnancy test before starting the study.
- Able to understand and willing to sign a consent form to participate in the study.
Exclusion Criteria
- Have another type of cancer that is getting worse or needs treatment, except for certain skin cancers or other specific conditions that are stable.
- Have had major surgery or extensive radiation, except for the main treatment of uveal melanoma.
- Have received additional treatment for uveal melanoma after the main tumor treatment.
- Have used drugs similar to quisinostat in the past.
- Cannot stop taking certain medications that interact with quisinostat without approval from the study doctor.
- Have taken other experimental drugs recently.
- Have allergies or reactions to drugs similar to quisinostat.
- Have certain heart conditions, like a long QT interval or a history of long QT syndrome.
- Have active infections like HIV, hepatitis B, or hepatitis C, unless they are under control.
- Have heart problems or irregular heartbeats that are not stable.
- Have uncontrolled health issues, such as infections, heart failure, or mental health conditions that would make it hard to follow the study requirements.
- Have a history of mental health or substance abuse issues that would interfere with participating in the study.
- Have difficulty making decisions independently.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Miami | 33136 | Miami | Florida |
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