Vorinostat in Treating Patients With Metastatic or Unresectable Melanoma (NCT00121225) | Clinical Trial Compass
CompletedPhase 2
Vorinostat in Treating Patients With Metastatic or Unresectable Melanoma
United States, Canada32 participantsStarted 2005-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Ab…
What they're measuring
1
Objective Response Rate Assessed by Response Evaluation Criteria for Solid Tumors (RECIST)