Phase I Assay-guided Trial of Anti-inflammatory Phytochemicals in Patients With Advanced Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Maximally-tolerated dose of Grape Seed Extract in Patients with Solid Tumors
研究概览
简要总结
This study is for subjects with solid cancers (gastrointestinal, lung, breast, prostate, lymphoma or cancer of the lymph nodes). The overall goal of this study is to identify plant-derived phytochemicals that can safely reduce systemic inflammation (inflammation throughout the entire body) in subjects with advanced cancer.
详细描述
This study will look at oligomeric procyanidin complex (OPC) and vitamin D3. OPC is the major part of Grape Seed Extract (GSE). Researchers are in looking at the combination of GSE and vitamin D in subjects with solid cancers (gastrointestinal, lung, breast, prostate, lymphoma or cancer of the lymph nodes). Researchers will examine the safety of the GSE and vitamin D when GSE is given at different doses. Researchers will also look at the effects of GSE and vitamin D on your quality of life and your body. In particular, they will look at differences in biomarkers in your blood and urine.
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
- •Subjects must have a histological diagnosis of cancer
- •Subjects must be 21 or more years of age
- •Subjects must have metastatic or locally advanced, unresectable cancer. Cancer must be "active" (i.e. demonstrable by physical examination, blood tests, or radiographical procedures).
- •Subjects may not initiate a new form of cancer therapy, non-steroidal or steroid anti-inflammatory agents, or antibiotics during the study period or for 4 weeks prior to the start of study agents.
- •Subjects must be able to give written consent to the study.
- •Subjects must have adequate hematologic, renal, and hepatic function at baseline, as follows:
- •Hematology parameters: ANC >1500/mcL, platelets > 100,000/mcL, Hgb >8.0gm/dL
- •Renal Function: Creatinine <1.8mg/mL
- •Liver Function: Total bilirubin ≤ULN, AST and ALT <1.5xULN, Alk phosphatase <2.5xULN
- •Subjects must have normal serum phosphate and serum calcium levels:
- •Serum Phosphate > 2.3 and < 4.8 mg/dL
- •Serum Calcium > 8.5 and < 10.5
- •Subjects may be receiving anti-cancer treatment, but this treatment should be have been instituted at least 4 weeks prior to enrollment, and may not change during the study period.
排除标准
- •Uncontrolled cancer requiring the institution of new anti-cancer therapy during the study period.
- •Presence of any severe or uncontrolled concurrent medical condition which, in the opinion of the investigator, would increase the risk of serious toxicity from the study drugs.
- •Any uncontrolled systemic inflammatory disease or infection requiring antibiotics, non-steroidal, or steroidal anti-inflammatory agents.
- •Initiation of strong antioxidant supplements during treatment, or ongoing use of supplements containing concentrated plant-derived polyphenols (pine bark, grape seed, green tea, milk thistle extracts; resveratrol; ellagic acid)
- •Pregnancy or breast feeding
- •Any history of allergies to grapes or grape seed.
- •Current treatment with lenalidomide, thalidomide, imipquimod, interferon, cytokines (G-CSF, GM-CSF, IL-1Rα), TNFα antagonists, or Lithium.
- •History of sarcoidosis
- •History of hypercalcemia
- •Use of any non-protocol vitamin D supplementation.
- •Uncontrolled hypertension
- •Current treatment with warfarin
研究组 & 干预措施
Grape Seed Extract and Vitamin D
All patients will take Grape Seed Extract from Day 1 to Day 21. All patients will take Grape Seed Extract and Vitamin D together from Day 22 until Day 64. For all patients on the study, patients will take Vitamin D once a day at a dose of 4000IU.
干预措施: Grape Seed Extract (Drug)
Grape Seed Extract and Vitamin D
All patients will take Grape Seed Extract from Day 1 to Day 21. All patients will take Grape Seed Extract and Vitamin D together from Day 22 until Day 64. For all patients on the study, patients will take Vitamin D once a day at a dose of 4000IU.
干预措施: Vitamin D (Drug)
结局指标
主要结局
Maximally-tolerated dose of Grape Seed Extract in Patients with Solid Tumors
时间窗: 2 years
Decisions to escalate or expand a dose level will be based only on the GSE-only treatment period (day 1-21). To be evaluable for toxicity, a patient must receive at least 3 weeks of GSE treatment, or have experienced dose-limiting toxicity (DLT). All patients enrolled are to be fully followed for toxicity, but any patients who are not evaluable for toxicity will be replaced.
次要结局
- IL6 Response(2 years)
研究者
Michael Lilly
Associate Professor
Medical University of South Carolina