NCT01587352Active, not recruitingPhase 2
Vorinostat in Treating Patients With Metastatic Melanoma of the Eye
A Phase 2 Study of Vorinostat (NSC 701852) in Metastatic Uveal Melanoma
Source: ClinicalTrials.gov · Last updated 29 Jul 2026
Brief summary (registry, in English)
This phase II trial studies how well vorinostat works in treating patients with melanoma of the eye that has spread to other parts of the body (metastatic). Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 26 Apr 2012
- Start date
- 29 May 2012
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- National Cancer Institute (NCI)
- Diseases
- Melanoma
- NCT number
- NCT01587352
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 40
- From 29 May 2012 to the primary completion date, 31 Dec 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients may have had any number of prior therapies. At least 3 weeks must have elapsed since the last dose of systemic therapy. At least 6 weeks must have elapsed if the last regimen included BCNU or mitomycin C. At least 6 weeks must have elapsed if the last regimen included an anti-CTLA4 antibody. Patients must have experienced disease progression on their prior therapy in the opinion of the treating investigator
- Patients who are receiving any other investigational agents
- Patients receiving HDAC inhibitors or compounds with HDAC inhibitor like activity, such as valproic acid, are ineligible. Patients who have received such agents may enroll on this study after a 14-day washout period
- Pregnant women are excluded from this study because vorinostat is a Class D agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with vorinostat, breastfeeding should be discontinued if the mother is treated with vorinostat
- No concomitant anti-cancer chemotherapy or other systemic drugs. Palliative radiation therapy will be allowed as long as the patient meets all other eligibility criteria
Other illness
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to vorinostat
- A second malignancy requiring active therapy
- Refractory nausea and vomiting, chronic gastrointestinal diseases (e.g., inflammatory bowel disease), or significant bowel resection that would preclude adequate absorption
Lab values
- Patients on warfarin will be excluded from the trial if they cannot be switched to an acceptable alternative medication (i.e. low molecular weight heparin \[LMWH\]). Prolongation of prothrombin time (PT) and International Normalized Ratio (INR) were observed in patients receiving vorinostat concomitantly with coumarin-derivative anticoagulants
- Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy will be eligible unless the CD4 count is \< 200 cells/mm\^3 within one month of study enrollment (as requested by Cancer Therapy Evaluation Program \[CTEP\]). These patients are at increased risk of lethal infections when treated with marrow-suppressive therapy
- Corrected QT interval (QTc) \> 475 milliseconds
Other
- Patients with active or untreated brain metastases. Treated brain metastases must have been stable for at least 2 months
- Patients who cannot swallow capsules
Who the study is looking for
- Patients must have metastatic histologically or cytologically confirmed uveal melanoma. (If histologic or cytologic confirmation of the primary is not available, confirmation of the primary diagnosis of uveal melanoma by the treating investigator can be clinically obtained, as per standard practice for uveal melanoma). Pathologic confirmation of diagnosis will be performed at Columbia University, Memorial Sloan-Kettering Cancer Center (MSKCC) or Vanderbilt University Medical Center
- Patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- Age \>= 18 years. Because limited dosing or adverse event data are currently available on the use of vorinostat in patients \< 18 years of age, children are excluded from this study, but will be eligible for future pediatric single-agent trials, if applicable
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)
- Life expectancy of greater than 3 months
- Leukocytes \>= 3,000/mcL
- Absolute neutrophil count \>= 1,500/mcL
- Platelets \>= 100,000/mcL
- Hemoglobin \>= 9.0 g/dL not requiring transfusions within the past 2 weeks
- Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN); =\< 3 x institutional ULN if the patient has Gilbert's syndrome
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional ULN if no liver metastasis present; =\< 5 x institutional ULN if liver metastases are present
- Creatinine =\< 1.5 mg/dL
- Ability to understand and the willingness to sign a written informed consent document
- Vorinostat is toxic to the developing human fetus. For this reason and because Class D agents are known to be teratogenic, women of child-bearing potential and men must agree to use effective contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of vorinostat administration
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vanderbilt University/Ingram Cancer Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.