DFMO & SULINDAC TO DECREASE RATE OF RECURRENCE OF ADENOMATOUS POLYPS IN COLON

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。这项研究是通过研究患有结肠或直肠息肉（异常组织生长）的人来调查大肠（结肠和直肠）的癌症。患有这种疾病的人患息肉和大肠癌的风险会增加。通常治疗息肉的方法是在可能的情况下切除息肉，或者通过结肠镜检查（一种检查肠道、直肠和结肠内部的程序）和活检（取组织样本）仔细观察息肉。活组织检查是为了确保组织中没有表明癌症发展的变化。大肠癌的发生与肠壁中某些化学物质（多胺、前列腺素）的存在有关。本研究的目的是确定DFMO 500mg (250mg × 2)/天加Sulindac 150mg/天口服超过36个月是否会减少息肉的发展。多胺和前列腺素的水平也将被测量。这项研究的另一个目的是确定这些药物在这些剂量下是否会产生副作用。这项研究的参与者将被要求每天口服DFMO加舒林达克或安慰剂（非活性药物）的组合，共3年。你将被分配到一个叫做随机化的治疗过程中，这个过程类似于抛硬币。虽然局部DFMO是一种被批准用于特殊适应症的药物，但DFMO被认为是一种研究药物（未被美国食品和药物管理局批准供医生一般使用）。Sulindac被批准用于某些目的，但尚未被批准用于我的病情，因此被认为是研究性的。在美国的累积站点网络中，大约有500名患者将被纳入研究。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This research study is investigating cancer of the large bowel (colon and rectum) by studying persons with colon or rectal polyps (abnormal tissue growth). People with this condition are at increased risk for subsequent polyps and large bowel cancer. The usual treatment for polyps is to remove them when possible or carefully follow them with colonoscopy (a procedure used to look at the inside of the bowel, rectum and colon) and biopsy (taking samples of tissue.) Biopsies are done to make sure that there are no changes in the tissue suggesting the development of cancer. The development of large bowel cancer has been related to the presence of certain chemical substances (polyamines, prostaglandins) in the lining of the bowel. The purpose of this study is to determine whether DFMO 500mg (250mg x 2)/day plus Sulindac 150mg/day taken by mouth every day, will decrease the development of polyps when given over 36 months. The levels of polyamines and prostaglandins will also be measured. Another purpose for this study is to determine if side effects develop as the result of these drugs at these doses. Participants in this study will be asked to take either the combination of DFMO plus Sulindac or a placebo (inactive agent) orally each day for a total of 3 years. You will be assigned to a treatment using a process called randomization, which is similar to flipping a coin. Although topical DFMO is an approved drug for a specialized indication, DFMO is regarded an investigational drug (not approved by the United States Food and Drug Administration for general use by physicians). Sulindac is approved for certain purposes but has not been approved for my condition and is therefore considered investigational. Over the Network of accrual sites across the United States, approximately 500 patients will be entered into the study.