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

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

FACILITYZIPCITYSTATE
University of Miami33136MiamiFlorida

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