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 range
18 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective Response Rate Assessed by Response Evaluation Criteria for Solid Tumors (RECIST)