Project 3 - Phase I/II Trial of Trametes Versicolor

项目3-栓菌I/II期试验

• 批准号: 6880820
• 负责人: LEANNA J STANDISH
• 金额: $ 16.64万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-15 至 2007-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6880820
• 关键词: Basidiomycetes; alternative medicine; biological products; breast neoplasms; clinical trial phase I; clinical trial phase II; cooperative study; drug screening /evaluation; fatigue; female; human subject; human therapy evaluation; immune response; immunomodulators; interferon gamma; leukocyte activation /transformation; leukocyte count; natural killer cells; neoplasm /cancer chemotherapy; neoplasm /cancer immunotherapy; neoplasm /cancer radiation therapy; oral administration; patient oriented research; phagocytosis; quality of life; therapy adverse effect; tumor necrosis factor alpha; women' s health

Extracts of the medical mushroom Trametes versicolor (Tv) are prescribed as adjunctive immune therapy for women with breast cancer in both Asia and by licensed N. American naturopathic physicians. Japanese data suggest that Tv may improve survival and reduce recurrence in early stage breast cancer. While Tv is prescribed by NDs and other CAM practitioners and used with growing frequency among breast cancer patients as an over-the-counter supplement there have yet to be well-designed clinical studies in the U.S. Standardized commercially available products are in wide use. The proposed phase I/II clinical trial of orally administered Tv will be the first U.S. trial of this promising CAM adjunctive immunomodulatory cancer therapy. Primary Aims: 1) To conduct an observational study (n=22) with estrogen receptor negative Stage I and Ila breast cancer patients in order to monitor and quantify the natural course of immune recovery and adverse events, as well as changes in fatigue and QOL scores, during the six weeks immediately following the completion of radiation therapy. 2) To determine the safety and tolerability of orally administered capsules of standardized Tv using a modified Fibonacci dose-escalation design (n=24) with doses ranging from 3000 mg - 12,000 mg/day. The goal of the phase I trial is to determine the maximally tolerated dose. Secondary Aims: 3) To gather preliminary data that compare baseline and post-treatment immunologic measures in up to a maximum of four Tv dose cohorts depending on the MTD: 3000 mg, 6000 mg, 9000 mg, and 12,000 rag/day oral doses of encapsulated standardized Tv. End points include white blood cells (WBC), natural killer cell activity, macrophage phagocytic index, and peripheral blood mononuclear cell production of levels of interferon gamma and turrior necrosis factor-alpha. 4) To determine the feasibility of measuring changes infatigue and quality of life changes associated with Tv administration in women with Stage I or Ila breast cancer who have recently completed chemotherapy and radiation therapy. Breast cancer patients will be recruited from two cities, Seattle and Minneapolis. Study subjects will be screened and evaluated at the Bastyr University's Center for Natural Health in Seattle and the University of Minnesota's General Clinical Research Center. Each site will be responsible for recruiting and evaluating 23 patients each. All clinical data will be sent to the Center's Clinical Data Core located at Bastyr for data entry and analysis. These preliminary data will assist the Center in estimating effect sizes for later randomized efficacy trials of Tv in breast cancer patients.

药用蘑菇Trametes versicolor（Tv）的提取物在亚洲和美国都被用于乳腺癌妇女的免疫治疗。美国自然疗法医师日本的数据表明，Tv可以提高早期乳腺癌的生存率并减少复发。虽然Tv是由ND和其他CAM从业者开的处方，并且在乳腺癌患者中作为非处方补充剂使用的频率越来越高，但在美国尚未进行精心设计的临床研究。拟议的口服Tv的I/II期临床试验将是这种有前途的CAM免疫调节癌症治疗的第一个美国试验。 主要目标：1）对雌激素受体阴性的I期和IIa期乳腺癌患者进行观察性研究（n=22），以监测和量化免疫恢复和不良事件的自然过程，以及在放射治疗完成后立即进行的六周期间疲劳和QOL评分的变化。2)为了确定口服标准化Tv胶囊的安全性和耐受性，使用改良的 Fibonacci剂量递增设计（n=24），剂量范围为3000 mg -12，000 mg/天。I期试验的目的是确定最大耐受剂量。次要目标：3）收集初步数据，比较最多四个Tv剂量组中的基线和治疗后免疫学测量，这取决于MTD：3000 mg、6000 mg、9000 mg和12，000 mg/天口服剂量的封装标准化Tv。终点包括白色血细胞（WBC）、自然杀伤细胞活性、巨噬细胞吞噬指数和外周血单核细胞产生的干扰素γ和肿瘤坏死因子-α水平。4)在近期完成化疗和放疗的I期或IIa期乳腺癌患者中，确定测量与Tv给药相关的疲劳变化和生活质量变化的可行性。乳腺癌患者将从西雅图和明尼阿波利斯两个城市招募。研究对象将在位于西雅图的巴斯蒂尔大学自然健康中心和明尼苏达大学综合健康中心进行筛选和评估。 临床研究中心。每家临床试验机构将负责招募和评价23例患者。所有临床数据将发送至位于Bastyr的中心临床数据中心进行数据录入和分析。这些初步数据将有助于该中心估计Tv在乳腺癌患者中后续随机疗效试验的效应量。