NCT00075777已完成不适用
A Pilot Trial Of Valproic Acid In Patients With Kaposi's Sarcoma
AIDS Malignancy Consortium13 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2005年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 13
- 主要终点
- Toxicity-related discontinuation rate
研究概览
简要总结
RATIONALE: Valproic acid may help stop the growth of Kaposi's sarcoma cells by blocking the enzymes necessary for tumor cell growth.
PURPOSE: This clinical trial is studying valproic acid in treating patients with HIV-related Kaposi's sarcoma.
详细描述
OBJECTIVES:
Primary
- Determine the safety of valproic acid in patients with Kaposi's sarcoma.
- Determine the effects of this drug on human herpes virus 8 (KSHV) gene expression using polymerase chain reaction and immunohistochemistry in these patients.
Secondary
- Determine the effects of this drug on HIV, KSHV, and Epstein-Barr virus viral loads in the plasma and peripheral blood mononuclear cells of these patients.
- Determine clinical response 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed HIV-related Kaposi's sarcoma (KS)
- •Disease involving the skin and/or lymph nodes
- •No symptomatic visceral disease
- •No oral KS as the only site of disease
- •Slowly progressive or stable disease allowed
- •Slow progression defined as fewer than 5 new lesions per month
- •Must have documented HIV infection by positive ELISA, western Blot, or viral load determination
- •CD4 T-cell count > 50/mm^3
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Karnofsky 60-100%
- •Life expectancy
- •At least 3 months
- •Hematopoietic
- •Hemoglobin ≥ 8.0 g/dL
- •Absolute neutrophil count ≥ 750/mm^3
- •Platelet count ≥ 75,000/mm^3
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)*
- •AST and ALT ≤ 3 times ULN
- •Albumin > 2.5 g/dL NOTE: *Elevated total bilirubin (≤ 3.5 mg/dL) secondary to indinavir therapy allowed provided the direct bilirubin is normal
- •Creatinine < 1.5 times ULN
- •Cardiovascular
- •No prior myocardial infarction
- •No evidence of cardiac ischemia
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after study participation
- •No prior lactic acidosis > 2.0 mmoles/L
- •No prior lipoatrophy or hypercholesterolemia secondary to retroviral treatment
- •No concurrent, acute, active opportunistic infection other than oral thrush or genital herpes within the past 14 days
- •No other concurrent neoplasm requiring cytotoxic therapy
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •More than 2 weeks since prior biologic therapy for KS
- •Chemotherapy
- •More than 2 weeks since prior chemotherapy for KS
- •No concurrent systemic cytotoxic chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •More than 2 weeks since prior radiotherapy for KS
- •Not specified
- •More than 2 weeks since other prior antineoplastic or local therapy for KS
- •More than 2 weeks since prior investigational therapy for KS
- •More than 60 days since prior local therapy to a KS-marker lesion unless lesion has clearly progressed since therapy
- •More than 1 year since prior valproic acid
- •Concurrent antiretroviral therapy allowed provided regimen has been stable for at least 4 weeks
- •No concurrent zidovudine
- 另有 2 项未显示
排除标准
- 未提供
结局指标
主要结局
Toxicity-related discontinuation rate
时间窗: 28 days
Lytic induction rate
时间窗: 28 days
Clinical response rate
时间窗: 28 days
Accelerated KS progression rate
时间窗: 28 days
次要结局
未报告次要终点
研究者
研究点 (13)
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