Vorinostat in Treating Patients With Metastatic or Unresectable Melanoma

Learn more about:
Related Clinical Trial
Sitravatinib and Tislelizumab in Patients With Metastatic Uveal Melanoma With Liver Metastases. Olaparib in Combination With Pembrolizumab for Advanced Uveal Melanoma Adjuvant Melatonin for Uveal Melanoma Targeted Alpha Particle Radiotherapy for Metastatic Uveal Melanoma Olaparib in Unresectable/Metastatic Melanoma With BRCA1/2 Prospective Registration Of Patient Data and Quality of Life in Eye Melanoma Patients Melanoma Vaccine Against Neoantigen and Shared Antigens by CD40 Activation and TLR Agonists In Patients With Melanoma (Including Ocular Melanoma) The Role of Genetic Mutations and of Circulating mRNAs in Uveal Melanoma A Study of Concurrent Stereotactic Body Radiotherapy With Ipi and Nivo in Metastatic Uveal Melanoma Single Arm Trial of Tumor-Treating Fields in Combination With Nivolumab and Ipilimumab in Metastatic Uveal Melanoma Managed Access Program Supporting Patient Access to Tebentafusp Efficacy of Spartalizumab Across Multiple Cancer-types in Patients With PD1-high mRNA Expressing Tumors Frequency and Clinical Phenotype of BAP1 Hereditary Predisposition Syndrome A Study of APG-115 in Combination With Pembrolizumab in Patients With Metastatic Melanomas or Advanced Solid Tumors Early Integration of Supportive Care Into Standard Oncology Care for Metastatic Uveal Melanoma Patients Defactinib (VS-6063) Combined With VS-6766 in Patients With Metastatic Uveal Melanoma Study of PAC-1 and Entrectinib for Patients With Metastatic Uveal Melanoma A Prospective Natural History Study in Uveal Melanoma Uveal Melanoma and Brachytheraphy: Long-term Outcomes. A Study of RO7293583 in Participants With Unresectable Metastatic Tyrosinase Related Protein 1 (TYRP1)-Positive Melanomas Study to Evaluate the Safety of IMM-01 in Patients With Advanced Solid Tumours Isolated Hepatic Perfusion in Combination With Ipilimumab and Nivolumab in Patients With Uveal Melanoma Metastases Study of Safety and Tolerability of BCA101 Alone and in Combination With Pembrolizumab in Patients With EGFR-driven Advanced Solid Tumors Follow-up of Patients With Uveal Melanoma Adapted to the Risk of Relapse (SALOME) Phase 2 Trial of AU-011 Via Suprachoroidal Administration With a Dose Escalation and Randomized, Masked Dose Expansion Designed to Evaluate Safety and Efficacy of AU-011 in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma Vorinostat in Treating Patients With Metastatic or Unresectable Melanoma A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies Cabozantinib-S-Malate Compared With Temozolomide or Dacarbazine in Treating Patients With Metastatic Melanoma of the Eye That Cannot Be Removed by Surgery Epacadostat and Vaccine Therapy in Treating Patients With Stage III-IV Melanoma Sargramostim, Vaccine Therapy, or Sargramostim and Vaccine Therapy in Preventing Disease Recurrence in Patients With Melanoma That Has Been Removed By Surgery A Study of PLX2853 in Advanced Malignancies. Combined PET/CT Imaging for the Early Detection of Ocular Melanoma Metastasis Compared to CT Scanning Alone A Trial of Niraparib in BAP1 and Other DNA Damage Response (DDR) Deficient Neoplasms (UF-STO-ETI-001) TTT Versus TTT and Triamcinolone to Decrease Exudation in Choroidal Melanoma After Proton Beam Therapy C7R-GD2.CART Cells for Patients With Relapsed or Refractory Neuroblastoma and Other GD2 Positive Cancers (GAIL-N) Genetic Predictors of Efficiency and Safety of ICIs in Patients With Different Malignancies (ICIPRESIST-0519) Treatment Of Radiation Retinopathy Trial Temozolomide or Selumetinib in Treating Patients With Metastatic Melanoma of the Eye Intravitreal Ranibizumab for the Prevention of Radiation Maculopathy Following Plaque Radiotherapy Ph 1 Study in Subjects With Tumors Requiring Arginine to Assess ADI-PEG 20 With Pemetrexed and Cisplatin Study in Subjects With Small Primary Choroidal Melanoma Study Multicentre Evaluating the Effectiveness and Toxicity Sorafenib (Nexavar®) in Adult Patients With Uveal Melanoma and Metastatic Dissemination Trial of AEB071 in Combination With BYL719 in Patients With Melanoma Halt Growth of Liver Tumors From Uveal Melanoma With Closure of Liver Artery Following Injection of GM-CSF Vorinostat in Treating Patients With Metastatic Melanoma of the Eye Radiation Therapy in Preventing Liver Metastases in Patients With Uveal Melanoma Who HaveMonosomy 3 or DecisionDx Class 2 Disease and Are More Likely to Develop Liver Metastases 5 Year Registry Study to Track Clinical Application of DecisionDx-UM Assay Results and Associated Patient Outcomes Hypofractionated Stereotactic Linear Accelerator Radiotherapy of Uveal Melanoma Study Evaluating Single and Repeated Intravitreal Doses of ICON-1 in Patients With Uveal Melanoma Pembrolizumab in Treating Patients With Advanced Uveal Melanoma Vascular Response to Brachytherapy Using Functional OCT Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma SIR-Spheres® 90Y Microspheres Treatment of Uveal Melanoma Metastasized to Liver Glembatumumab Vedotin in Treating Patients With Metastatic or Locally Recurrent Uveal Melanoma Dexamethasone Intravitreal Implant for Treatment of Macular Edema After Plaque Radiotherapy of Uveal Melanoma Stereotactic Body Radiation Therapy and Aflibercept in Treating Patients With Uveal Melanoma Endoresection of the Tumor Scar or Transpupillary Thermotherapy for the Treatment of Large Uveal Melanomas (Endoresection-Laser) Durvalumab (MEDI4736) Plus Cediranib in Patients With Metastatic Uveal Melanoma A Phase Ib/II Study of AEB071 and MEK162 in Adult Patients With Metastatic Uveal Melanoma Study of AntiCTLA4 in Patients With Unresectable or Metastatic Uveal Melanoma Tilting of Radioactive Plaques After Initial Accurate Placement for Treatment of Uveal Melanoma A Study of the Intra-Patient Escalation Dosing Regimen With IMCgp100 in Patients With Advanced Uveal Melanoma Trametinib With or Without GSK2141795 in Treating Patients With Metastatic Uveal Melanoma RAD001 (Everolimus) and Pasireotide (SOM230) LAR in Patients With Advanced Uveal Melanoma Safety & Activity of Controllable PRAME-TCR Therapy in Previously Treated AML/MDS or Metastatic Uveal Melanoma CAVATAK® and Ipilimumab in Uveal Melanoma Metastatic to the Liver (VLA-024 CLEVER) Comparison Between Fotemustin to Intensive Surveillance in Patients With High Risk Uveal Melanoma Dendritic Cells Plus Autologous Tumor RNA in Uveal Melanoma Study of Immunotherapy Plus ADI-PEG 20 for the Treatment of Advanced Uveal Melanoma New Biopsy Technique for Uveal Melanoma Selumetinib (AZD6244: ARRY-142886) (Hyd-Sulfate) in Metastatic Uveal Melanoma (SUMIT) Safety and Efficacy of AEB071 in Metastatic Uveal Melanoma Patients Influence of Oral Treatment With Citicoline for the Prevention of Radiation Optic Neuropathy in Patients Treated for Uveal Melanomas With Proton Beam Therapy Intermittent Selumetinib for Uveal Melanoma Transarterial Radioembolisation in Comparison to Transarterial Chemoembolisation in Uveal Melanoma Liver Metastasis A Phase I Study of LXS196 in Patients With Metastatic Uveal Melanoma. Evaluation Interest of the Circulating Tumor DNA Dosage in Patient With Hepatic Metastatic Uveal Melanoma Candidate to Complete Resection (ct DNA R0) Messenger Ribonucleic Acid (mRNA) Transfected Dendritic Cell Vaccination in High Risk Uveal Melanoma Patients Study of the Activity of PD-1 Inhibitors in Metastatic Uveal Melanoma A Study of Sorafenib in Patients With Chemonaive Metastatic Uveal Melanoma Crizotinib in High-Risk Uveal Melanoma Following Definitive Therapy Trial of Nivolumab in Combination With Ipilimumab in Subjects With Previously Untreated Metastatic Uveal Melanoma Vorinostat in Patients With Class 2 High Risk Uveal Melanoma Yttrium90, Ipilimumab, & Nivolumab for Uveal Melanoma With Liver Metastases A Phase II Study of BVD-523 in Metastatic Uveal Melanoma Assessing the Clinical Effectiveness of Serum Biomarkers in the Diagnosis of Metastatic Uveal Melanoma Treatment With Intravitreal Avastin for Large Uveal Melanomas

Brief Title

Vorinostat in Treating Patients With Metastatic or Unresectable Melanoma

Official Title

A Phase II Study of Vorinostat in Patients With Advanced Melanoma

Brief 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.

Detailed Description


      I. Determine the objective response rate in patients with metastatic or unresectable melanoma
      treated with vorinostat.


      I. Determine time to progression in patients treated with this drug. II. Determine the
      utility of HP1 and/or macro H2A nuclear foci as biomarkers of response in patients treated
      with this drug.

      III. Correlate the presence of 72R or 72P variant p53 polymorphisms with response and time to
      progression in patients treated with this drug.

      IV. Determine gene expression profiles that may predict response to this drug and gene
      expression changes that occur after treatment with this drug in these patients.

      OUTLINE: This is a multicenter study.

      Patients receive oral vorinostat once daily on days 1-28. Courses repeat every 28 days in the
      absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed for 4 weeks and then every 3
      months thereafter.

Study Phase

Phase 2

Study Type


Primary Outcome

Objective Response Rate Assessed by Response Evaluation Criteria for Solid Tumors (RECIST)

Secondary Outcome

 Time to Progression Assessed by RECIST


Ciliary Body and Choroid Melanoma, Medium/Large Size



Study Arms / Comparison Groups

 Arm I
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.


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

September 2005

Completion Date

June 2013

Primary Completion Date

March 2009

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

          -  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




18 Years - N/A

Accepts Healthy Volunteers



Naomi Balzer-Haas, , 

Location Countries


Location Countries


Administrative Informations



Organization ID


Secondary IDs


Responsible Party


Study Sponsor

National Cancer Institute (NCI)

Study Sponsor

Naomi Balzer-Haas, Principal Investigator, Princess Margaret Hospital Phase 2 Consortium

Verification Date

January 2019