Clinical trial · Interventional
Vorinostat in Treating Patients With Metastatic or Unresectable Melanoma
A Phase II Study of Vorinostat in Patients With Advanced Melanoma
NCT00121225CI-TRIAL-00036802completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ciliary Body and Choroid Melanoma, Medium/Large Size | Medium/Large Size Posterior Uveal Melanoma | ALIAS | 0.90 |
| Extraocular Extension Melanoma | Ocular Melanoma with Extraocular Extension | ALIAS | 0.90 |
| Iris Melanoma | Iris Melanoma | ONTOLOGY_EXACT | 0.98 |
| Recurrent Intraocular Melanoma | Uveal Melanoma | CURATED_BROADER | 0.78 |
| Recurrent Melanoma | Melanoma | CURATED_BROADER | 0.78 |
| Stage IV Melanoma | Melanoma | CURATED_BROADER | 0.78 |
| Uveal Melanoma | Uveal Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| vorinostat | Drug | Vorinostat | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 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.
- interventionNames
- Drug: vorinostat
Primary outcomes (1)
- measure
- Objective Response Rate Assessed by Response Evaluation Criteria for Solid Tumors (RECIST)
- timeFrame
- Up to 5 years
- description
- Per Response Evaluation Criteria in Solid Tumours Criteria (RECIST v1.0) for target lesions and are assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least 30% decrease in sum of longest diameter of target lesions; Objective Response (OR) = CR+ PR.
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTHaas NB, Quirt I, Hotte S, McWhirter E, Polintan R, Litwin S, Adams PD, McBryan T, Wang L, Martin LP, vonMehren M, Alpaugh RK, Zweibel J, Oza A. Phase II trial of vorinostat in advanced melanoma. Invest New Drugs. 2014 Jun;32(3):526-34. doi: 10.1007/s10637-014-0066-9. Epub 2014 Jan 25. PMID 24464266