Planning a Trial of Sulindac for Oral Leukoplakia

计划试用舒林酸治疗口腔白斑

基本信息

批准号：
6954197
负责人：
JAY O BOYLE
金额：
$ 14.41万
依托单位：
SLOAN-KETTERING INST CAN RESEARCH
依托单位国家：
美国
项目类别：
财政年份：
2004
资助国家：
美国
起止时间：
2004-09-28 至 2008-08-31
项目状态：
已结题

项目摘要

DESCRIPTION (provided by applicant): Funding is requested to plan a multi-center, randomized, double-blind, placebo-controlled chemoprevention trial of sulindac for oral leukoplakia through an international collaboration between Memorial Sloan-Kettering Cancer Center (MSKCC) in New York and the Amrita Institute of Medical Sciences (AIMS) in Kerala, India. An informal, yet critical objective of the proposed trial is to determine the feasibility of conducting such international studies in populations in which the prevalence of oral cancer and ieukoplakia are among the highest in the world. The primary scientific objective is to test the clinical efficacy and safety of sulindac against oral premalignant lesions (OPL) and biomarkers in OPL tissue (DNA ploidy, Ki67 and p53 IHC, COX-2 expression). 66 oral leukoplakia patients will be enrolled from both AIMS and MSKCC. Patients will be randomized to receive either sulindac 150-mg bid or placebo bid for 6 months, and will remain under observation for an additional two months. All data management and biomarkers will be performed at MSKCC except DNA ploidy, which will be measured at AIMS. The objective of this planning grant is to develop a complete manual of procedures (MOP) to facilitate consistency in protocol implementation and data collection across patients and between clinic sites. The specific aims of the planning grant are to: 1) refine the study protocol and data and safety monitoring plan, 2) prepare the agent for clinical trial use (bioavailability, packaging, shipping, regulatory) 3) establish procedures for packing, labeling and shipping drug and biological specimens, 4) further refine the plan for biomarkers including DNA ploidy, and genetic polymorphisms. The proper planning of each aspect of this international trial is time consuming and yet critical to the safe and successful completion. Performing these trials in endemic regions is necessary to advance the field.

描述（由申请人提供）：要求资金通过纽约州纽约市和阿姆里塔医学科学院（Amrita of Medical Sciences of Medical Sciences in India）之间的国际合作计划，以计划对苏氏苏氏硫酸的多中心，随机，双盲，安慰剂控制的化学预防试验，用于口服白细胞。拟议试验的一个非正式但关键的目标是确定在口腔癌和Ieukoplakia的患病率中进行此类国际研究的可行性。主要的科学目标是测试硫酸对OPL组织中口服前病变（OPL）（OPL）（OPL）和生物标志物（DNA ploidy，Ki67和p53 IHC，COX-2表达）的临床疗效和安全性。 66名AIMS和MSKCC的口服白细胞病患者将被招募。患者将被随机接收Sulindac 150毫克竞标或安慰剂竞标6个月，并将继续观察两个月。除了DNA ploidy外，所有数据管理和生物标志物都将在MSKCC上进行，该数据将以AIMS进行测量。该计划赠款的目的是制定完整的程序手册（MOP），以促进患者和诊所之间的协议实施和数据收集的一致性。计划赠款的具体目的是：1）完善研究方案，数据和安全监控计划，2）准备临床试验的代理（生物利用度，包装，运输，监管）3）建立包装，标签和运输药物和生物学标本的程序，4）进一步完善包括DNA Ploidy Ploidy和Genterymorphismss和Genterymorphismss的生物标志的计划。这项国际审判的各个方面的适当计划是耗时的，但对于安全和成功的完成至关重要。在流行区域进行这些试验对于推进该领域是必要的。