Clinical trial NCT00121225 (phase 2, status: completed)
Conditions: ciliary body and choroid melanoma, medium/large size, extraocular extension melanoma, iris melanoma, uveal melanoma, recurrent intraocular melanoma, recurrent melanoma, stage iv melanoma
ICD codes: C43.0, C43.31, D03.9, C43.51, C43.9, D03.0, C43.4, H05.823, H05.821, H05.822, H05.829, C43.0, C43.31, D03.9, C43.51, C43.9, D03.0, C43.4, C43.0, C43.31, D03.9, C43.51, C43.9, D03.0, C43.4, Z96.1, T85.22XS, T85.21XS, T85.22XA, T85.22XD, T85.21XA, T85.21XD, G47.13, J01.41, K11.22, K12.0, N96, F33.8, G03.2, C43.0, C43.31, D03.9, C43.51, C43.9, D03.0, C43.4
Drugs: vorinostat
SMILES: ONC(=O)CCCCCCC(=O)NC1=CC=CC=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically/cytologically confirmed melanoma that is metastatic/unresectable

          -  Residual, recurrent, or metastatic disease by radiographic examination. Measurable
             disease (at least 1 lesion in at least 1 dimension (longest diameter) as >20mm with
             conventional techniques or >10mm with spiral CT scan, within 4 weeks prior to
             registration

          -  No prior therapy or 1 prior treatment (cytokine/chemotherapy/combination) for
             metastatic disease allowed. Patients should not take valproic acid, another histone
             deacetylase inhibitor, for at least 2 weeks prior to enrollment. At least 4 weeks from
             prior therapy to be eligible or 6 weeks if last regimen included BCNU or mitomycin C

          -  Age>=18 years

          -  Life expectancy >=3 months.

          -  ECOG<2 (Karnofsky ≥60%)

          -  Leukocytes >3,000/mcL

          -  Absolute neutrophil count >1,500/mcL

          -  Platelets >100,000/mcL

          -  Total bilirubin within institutional limits

          -  AST/ALT≤2.5Xinstitutional ULN

          -  Creatinine within institutional limits OR creatinine clearance >60mL/min/1.73 m2 if
             creatinine levels above institutional limits

          -  Eligibility of patients taking medications with potential to affect activity/PK of
             Vorinostat will be determined by PI

          -  Must not use concomitant steroids except topical/inhaled use

          -  Vorinostat effects on developing human fetus are unknown. Women of childbearing
             potential (WOCBP) and sexually active males must agree to use accepted/effective
             contraception method prior to study entry and for duration of the study

          -  Ability to understand/willingness to sign written informed consent

          -  Must have paraffin block of tumor tissue available for future studies

        Exclusion Criteria:

          -  Chemotherapy/radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C)
             prior to entering study

          -  May not be receiving any other investigational agents

          -  Known brain metastases

          -  History of allergic reactions attributed to compounds of similar chemical/biologic
             composition to Vorinostat

          -  Uncontrolled intercurrent illness including but not limited to ongoing/active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  Pregnant women excluded because Vorinostat is a HDAC inhibitor agent with potential
             for teratogenic or abortifacient effects

          -  HIV-positive patients receiving combination antiretroviral therapy are ineligible
             because of potential for PK interactions with Vorinostat