Vorinostat in Treating Patients With Metastatic Melanoma of the Eye (NCT01587352) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Vorinostat in Treating Patients With Metastatic Melanoma of the Eye
United States40 participantsStarted 2012-05-29
Plain-language summary
This phase II trial studies how well vorinostat works in treating patients with melanoma of the eye that has spread to other parts of the body (metastatic). Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients must have metastatic histologically or cytologically confirmed uveal melanoma. (If histologic or cytologic confirmation of the primary is not available, confirmation of the primary diagnosis of uveal melanoma by the treating investigator can be clinically obtained, as per standard practice for uveal melanoma). Pathologic confirmation of diagnosis will be performed at Columbia University, Memorial Sloan-Kettering Cancer Center (MSKCC) or Vanderbilt University Medical Center
* Patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
* Age \>= 18 years. Because limited dosing or adverse event data are currently available on the use of vorinostat in patients \< 18 years of age, children are excluded from this study, but will be eligible for future pediatric single-agent trials, if applicable
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)
* Life expectancy of greater than 3 months
* Leukocytes \>= 3,000/mcL
* Absolute neutrophil count \>= 1,500/mcL
* Platelets \>= 100,000/mcL
* Hemoglobin \>= 9.0 g/dL not requiring transfusions within the past 2 weeks
* Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN); =\< 3 x institutional ULN if the patient has Gilbert's syndrome
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =…
What they're measuring
1
Overall response rate in patients with uveal melanoma