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Vorinostat in Treating Patients With Metastatic or Unresectable Melanoma | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Vorinostat in Treating Patients With Metastatic or Unresectable Melanoma

A Phase II Study of Vorinostat in Patients With Advanced Melanoma

NCT00121225•National Cancer Institute (NCI)

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

PRIMARY OBJECTIVE: I. Determine the objective response rate in patients with metastatic or unresectable melanoma treated with vorinostat. SECONDARY OBJECTIVES: 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+7 more criteria

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

Locations (5)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center

Rockledge, Pennsylvania, United States

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, Canada

Princess Margaret Hospital Phase 2 Consortium

Toronto, Ontario, Canada

University Health Network-Princess Margaret Hospital

Toronto, Ontario, Canada

Key Dates

Start Date

September 1, 2005

Primary Completion Date

March 1, 2009

Completion Date

June 1, 2013

Last Updated

January 29, 2019

Enrollment

ACTUAL participants

Conditions

Ciliary Body and Choroid Melanoma, Medium/Large SizeExtraocular Extension MelanomaIris MelanomaUveal MelanomaRecurrent Intraocular MelanomaRecurrent MelanomaStage IV Melanoma

Interventions

vorinostat

DRUG

Vaccine Therapy in Treating Patients With Metastatic Melanoma of the Eye

NCT00020475

Extraocular Extension MelanomaRecurrent Intraocular Melanoma

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TERMINATEDEARLY_PHASE1

Radioembolization and Ipilimumab in Treating Patients With Uveal Melanoma With Liver Metastases

NCT01730157

Ciliary Body and Choroid Melanoma, Medium/Large SizeCiliary Body and Choroid Melanoma, Small Size+6 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 29, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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