NCT00121225已完成2 期
A Phase II Study of Vorinostat in Patients With Advanced Melanoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 4
- 主要终点
- Objective Response Rate Assessed by Response Evaluation Criteria for Solid Tumors (RECIST)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Ability to understand/willingness to sign written informed consent
- •Must have paraffin block of tumor tissue available for future studies
排除标准
- •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
研究组 & 干预措施
Arm I
Experimental
Patients will receive vorinostat by mouth once a day for 4 weeks. Treatment may repeat every 4 weeks for as long as benefit is shown. Patients will be evaluated for 4 weeks and every 3 months thereafter.
干预措施: vorinostat (Drug)
结局指标
主要结局
Objective Response Rate Assessed by Response Evaluation Criteria for Solid Tumors (RECIST)
时间窗: Up to 5 years
Per Response Evaluation Criteria in Solid Tumours Criteria (RECIST v1.0) for target lesions and are assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least 30% decrease in sum of longest diameter of target lesions; Objective Response (OR) = CR+ PR.
次要结局
- Time to Progression Assessed by RECIST(Up to 5 years)
- Difference in HP1 and MacroH2A Nuclear Foci Expression Between Progressive Minus Stable Disease Outcomes(Baseline and day 15)
- Number of Patients With p53 Allelic Variations (72R or 72P)(Baseline)
- Comparison of VEGF Serum Levels to Response to Vorinostat(Baseline, Day 1, Day 8 and Day 15)
研究者
研究点 (4)
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