Vorinostat in Treating Patients With Metastatic or Unresectable Melanoma

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Ciliary Body and Choroid Melanoma, Medium/Large Size
Extraocular Extension Melanoma
Iris Melanoma
Melanoma
Recurrent Intraocular Melanoma
Recurrent Melanoma
Stage IV Melanoma
Uveal Melanoma

Clinical Trial Details

NCT number	NCT00121225
Study type	Interventional
Source	National Cancer Institute (NCI)
Contact
Status	Completed
Phase	Phase 2
Start date	September 2005
Completion date	June 2013

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02107755` - Stereotactic Radiation Therapy and Ipilimumab in Treating Patients With Metastatic Melanoma	Phase 2
Withdrawn	`NCT01216787` - RO4929097 in Treating Patients With Stage IIIB, Stage IIIC, or Stage IV Melanoma That Can Be Removed by Surgery	Phase 2
Active, not recruiting	`NCT01026324` - Dinaciclib in Treating Patients With Stage III-IV Melanoma	Phase 1/Phase 2
Completed	`NCT01010984` - LC Bead Embolization Agent With Doxorubicin in the Treatment Liver Metastasis From Melanoma	N/A
Completed	`NCT00553306` - Laboratory-Treated T Cells and Aldesleukin After Cyclophosphamide in Treating Patients With Stage IV Melanoma	Phase 1/Phase 2
Completed	`NCT00019448` - Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma	Phase 2
Active, not recruiting	`NCT03200847` - Pembrolizumab and All-Trans Retinoic Acid Combination Treatment of Advanced Melanoma	Phase 1/Phase 2
Active, not recruiting	`NCT03235245` - Immunotherapy With Ipilimumab and Nivolumab Preceded or Not by a Targeted Therapy With Encorafenib and Binimetinib	Phase 2
Terminated	`NCT01875653` - Autologous Dendritic Cell-Tumor Cell Immunotherapy for Metastatic Melanoma	Phase 3
Completed	`NCT01748747` - Vaccine Therapy and Resiquimod in Treating Patients With Stage II-IV Melanoma That Has Been Removed By Surgery	Early Phase 1
Terminated	`NCT01316692` - Aurora A Kinase Inhibitor MLN8237 in Treating Patients With Unresectable Stage III-IV Melanoma	Phase 2
Active, not recruiting	`NCT01120275` - Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Stage IV Melanoma	Phase 2
Terminated	`NCT01217411` - RO4929097 and Whole-Brain Radiation Therapy or Stereotactic Radiosurgery in Treating Patients With Brain Metastases From Breast Cancer	Phase 1
Terminated	`NCT01166126` - Temsirolimus/AZD 6244 for Treatment-naive With BRAF Mutant Unresectable Stage IV	Phase 2
Terminated	`NCT01026051` - Safety, Immune and Tumor Response to a Multi-component Immune Based Therapy (MKC1106-MT) for Patients With Melanoma	Phase 2
Completed	`NCT01037790` - Phase II Trial of the Cyclin-Dependent Kinase Inhibitor PD 0332991 in Patients With Cancer	Phase 2
Completed	`NCT00288041` - Bortezomib, Paclitaxel, and Carboplatin in Treating Patients With Metastatic Melanoma	Phase 2
Completed	`NCT00074308` - Imatinib Mesylate and Bevacizumab in Treating Patients With Advanced Melanoma or Other Advanced Cancers	Phase 1/Phase 2
Completed	`NCT00072163` - Temozolomide and Thalidomide in Treating Patients With Brain Metastases Secondary to Melanoma	Phase 2
Completed	`NCT00026143` - Interleukin-12 and Interferon Alfa in Treating Patients With Metastatic Malignant Melanoma	Phase 2