Vorinostat in Treating Patients With Metastatic or Unresectable Melanoma
Condition: Ciliary Body and Choroid Melanoma, Medium/Large Size; Extraocular Extension Melanoma; Iris Melanoma; Uveal Melanoma; Recurrent Intraocular Melanoma; Recurrent Melanoma; Stage IV Melanoma
MeSH terms: Melanoma; Recurrence
Intervention: vorinostat
Intervention description: Patients will receive vorinostat by mouth once a day for 4 weeks. Treatment may repeat every 4 weeks for as long as benefit is shown. Patients will be evaluated for 4 weeks and every 3 months thereafter.
Intervention MeSH terms: Vorinostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well vorinostat works in treating patients with
      metastatic or unresectable melanoma. Vorinostat may stop the growth of tumor cells by
      blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
    

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