NCT00917826终止2 期
A Phase II Trial of Low-Dose Arginine Butyrate and Ganciclovir/Valganciclovir in EBV(+)Lymphoid Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Response Rate (using Revised Response Criteria for Malignant Lymphoma, Cheson et al., JCO 2007)
研究概览
简要总结
The purpose of this study is to assess whether administration of Arginine Butyrate + ganciclovir/valganciclovir for up to three 21-day cycles is tolerable, and results in partial or complete responses in patients with EBV(+) lymphoid malignancies.
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
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 3 years. (No dosing or adverse event data are currently available on the use of valganciclovir in patients < 16 years of age.)
- •Life expectancy of > 3 months.
- •ECOG Performance Status 0-2 or Karnofsky Performance Scale ≥ 60%.
- •Baseline (untransfused) HbF level > 2%
- •Normal organ and marrow function defined as: (i) absolute neutrophil count of ≥ 1,000/µL. (ii) platelets ≥ 50,000/ µL. (iii) total bilirubin of ≤ 2.0 x upper limit of normal. (iv) AST (SGOT)/ALT(SGPT) of ≤ 2.0 x institutional upper limit of normal. (v) creatinine within normal range for institution.
- •Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
- •Able and willing to give informed consent.
排除标准
- •Patients that have received chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entry, or those who have not recovered form adverse events due to agents administered 4 weeks earlier.
- •Patients may not be receiving any other investigational agents.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to Arginine Butyrate, ganciclovir or valganciclovir.
- •Patients who have an acute myocardial infarction or onset of atrial fibrillation within the past 6 months.
- •Uncontrolled intercurrent illness including, but not limited to , ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Tumor impinging on an organ or anatomical structure deemed critical by the investigator.
- •Pregnant women.
研究组 & 干预措施
Arginine Butyrate + Ganciclovir/Valganciclovir
Experimental
干预措施: Arginine Butyrate (Drug)
Arginine Butyrate + Ganciclovir/Valganciclovir
Experimental
干预措施: Ganciclovir (Drug)
Arginine Butyrate + Ganciclovir/Valganciclovir
Experimental
干预措施: Valganciclovir (Drug)
结局指标
主要结局
Response Rate (using Revised Response Criteria for Malignant Lymphoma, Cheson et al., JCO 2007)
时间窗: Every three weeks. If a response is recorded evaluation continues until an objective determination of disease progression is made (assessment may continue after treatment is discontinued.)
次要结局
- Progression Rate (using Revised Response Criteria for Malignant Lymphoma, Cheson et al., JCO 2007)(Every three weeks. If a response is recorded evaluation continues until an objective determination of disease progression is made (assessment may continue after treatment is discontinued.))
- Safety as assessed by (1) adverse events, (2) laboratory values (3) vital signs (4) physical exam(Up to three 21-day cycles. If a response is recorded evaluation continues until an objective determination of disease progression is made (assessments may continue after treatment is discontinued.))
研究者
研究点 (1)
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