NCT00942422终止2 期
The Clinical and Biologic Evaluation of Polyphenon E, an Extract of Green Tea Containing EGCG, in Plasma Cell Dyscrasias - Pilot Study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Sustained M-protein Reduction of ≥ 25% From Baseline
研究概览
简要总结
RATIONALE: Green tea extract contains ingredients that may prevent or slow the growth of monoclonal gammopathy of undetermined significance and/or smoldering multiple myeloma.
PURPOSE: This phase II trial is studying how well green tea extract works in treating patients with monoclonal gammopathy of undetermined significance and/or smoldering multiple myeloma.
详细描述
OBJECTIVES:
Primary
- Conduct a pilot study investigating the effects of Polyphenon E, a compound extracted from green tea which contains epigallocatechin-3-gallate (EGCG), on monoclonal protein levels in patients with monoclonal gammopathy of undetermined significance and/or smoldering multiple myeloma.
Secondary
- Collect, process, and store blood and marrow specimens for future measurement of the biologic effects of Polyphenon E on the plasma cells of these patients by utilizing proteosome activity assays and gene expression profiling.
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
- •Measurable monoclonal protein in the serum (for immunoglobin [Ig]G or IgM, >= 1.0 g/dL using serum protein electrophoresis [SPEP]/immunofixation electrophoresis [IFE]; for IgA, an SPEP/IFE confirming the presence of a monoclonal IgA band plus a quantitative IgA level of >= 750 mg/dL) OR measurable urine Bence Jones paraprotein (>= 500mg/24hrs) OR a measurable serum free light chain (FLC), defined as an involved FLC level of >10 mg/dl, and a serum FLC ratio that is abnormal
- •Neutrophil count >= 1,500
- •Platelet count >= 100,000
- •Hemoglobin >= 9mg/dL
- •Alanine aminotransferase (ALT) =< institutional upper limit of normal (IULN)
- •Aspartate aminotransferase (AST) =< IULN
- •Total bilirubin =< IULN
- •Alkaline phosphatase =< IULN
- •Any ethnic group
- •Prior therapy is allowed if >= 4 weeks prior to registration
- •Life expectancy of at least 6 months
- •Ability to understand and the willingness to sign a written informed consent document
- •Willingness to comply with oral home treatment and visit schedule
- •Patients with reproductive capacity must be willing to use adequate contraception (barrier contraception, birth control pills, or other highly effective hormonal agents) or abstain from sexual activity for the duration of the study and 30 days beyond the end of therapy
排除标准
- •Pregnant women
- •Breastfeeding women
- •Confirmed symptomatic multiple myeloma (MM), defined by any of the following:
- •Lytic lesions on skeletal survey
- •Anemia attributable to plasma cell infiltrate in marrow
- •Hypercalcemia
- •Renal dysfunction not attributable to other causes
- •Uncontrolled intercurrent illness, including but not limited to active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness or social situations that would compromise compliance with study medication or follow up visits
- •Patients with high predisposition to gastrointestinal bleeding, such as known gastroesophageal varices or active peptic ulcer disease
- •Patients with chronic liver disease (such as hepatitis B, hepatitis C, or alcoholic cirrhosis)
- •Prior daily ingestion of green tea or green tea extract within 6 months of study entry
- •Patients who have previously experienced any adverse symptoms related to green tea or any of the inactive components present in Polyphenon E capsules
- •Concurrent use of investigational or commercial agent or therapy with the intent to treat MGUS and/or SMM
结局指标
主要结局
Sustained M-protein Reduction of ≥ 25% From Baseline
时间窗: Day one of each 28-day cycle for a total of up to 6 cycles
This is a monthly blood test, done at the beginning of each cycle of therapy. The M-protein is a surrogate marker routinely used to estimate the degree of plasma cell cyto-reduction brought about by therapy. In active multiple myeloma, a 25% reduction in the M-protein level would correspond to a "minor response," an improvement recognized as having some clinical benefit.
次要结局
未报告次要终点
研究者
Jeffrey Zonder
Principal Investigator
Barbara Ann Karmanos Cancer Institute
研究点 (2)
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