Study on Vorinostat for Treating Metastatic Eye Melanoma
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT01587352
This clinical trial is testing how well the drug vorinostat works in treating melanoma of the eye that has spread to other parts of the body. Vorinostat may help stop tumor growth by blocking certain enzymes needed for cell growth.
Patient Parameters
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Program Overview
This phase II study is exploring the effectiveness of vorinostat in patients with metastatic uveal melanoma, a type of eye cancer that has spread. Vorinostat is believed to work by inhibiting enzymes that are essential for tumor cell growth. The study aims to determine how well patients respond to the treatment, their overall survival, and how long they remain free from disease progression. Additionally, the study will assess the safety and tolerability of vorinostat in these patients.
Description
The main goal of this study is to see how well patients with metastatic uveal melanoma respond to treatment with vorinostat. Researchers will also look at how long patients live and how long they stay free from disease progression. The study will evaluate how well patients tolerate the drug.
Researchers will also explore how changes in certain biological markers relate to treatment outcomes. These markers include histone acetylation, cell growth, and cell death indicators. The study will also examine changes in specific pathways and levels of tumor-derived DNA in the blood.
Participants will take vorinostat orally twice a day for three days each week over a four-week cycle. This cycle will repeat every 28 days as long as the disease does not progress and side effects are manageable. After completing the treatment, patients will have follow-up visits every 12 weeks.
Eligibility Criteria
Inclusion Criteria
- Must have metastatic uveal melanoma confirmed by lab tests or clinical diagnosis.
- Must have measurable disease based on specific criteria.
- Must be 18 years or older.
- Must have a performance status score of 2 or less, indicating they are able to carry out light work.
- Must have a life expectancy of more than 3 months.
- Must meet specific blood count and organ function requirements.
- Must be able to understand and sign a consent form.
- Women of childbearing potential and men must agree to use effective birth control during the study and for a period after the study.
Exclusion Criteria
- Must not have had any other treatments for at least 3 weeks, or 6 weeks for certain drugs.
- Must not be taking other investigational drugs.
- Must not have active or untreated brain metastases.
- Must not have allergies to similar drugs as vorinostat.
- Must not be taking HDAC inhibitors or similar drugs unless a 14-day break is observed.
- Must not be on warfarin unless switched to another medication.
- Pregnant or breastfeeding women cannot participate.
- HIV-positive patients must have a CD4 count of 200 or more.
- Must not have another active cancer requiring treatment.
- Must not be taking other anti-cancer drugs.
- Must not have severe nausea, bowel diseases, or significant bowel surgery.
- Must not have a prolonged QT interval on an ECG.
- Must be able to swallow capsules.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | 10032 | New York | New York |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
| Vanderbilt University/Ingram Cancer Center | 37232 | Nashville | Tennessee |
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