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

DFMO

• 批准号: 7603734
• 负责人: Danielle Kim Turgeon
• 金额: $ 0.93万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2007-09-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7603734
• 关键词: Adenomatous Polyps; Adverse effects; Biopsy; Chemicals; Coin; Colon; Colon, Rectum; Colonoscopy; Colorectal Polyp; Computer Retrieval of Information on Scientific Projects Database; Condition; DL-alpha-Difluoromethylornithine; Development; Dose; Funding; Genus Cola; Grant; Growth; Institution; Intestines; Investigational Drugs; Malignant Neoplasms; Malignant neoplasm of large intestine; Measures; Oral cavity; Participant; Patients; Persons; Pharmaceutical Preparations; Physicians; Placebos; Polyamines; Polyps; Procedures; Process; Prostaglandins; Purpose; Randomized; Rate; Rectal Polyp; Recurrence; Research; Research Personnel; Resources; Risk; Site; Source; Sulindac; Tissue Sample; Tissues; United States; United States Food and Drug Administration; United States National Institutes of Health; day; research study

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.'

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 本研究通过研究结肠或直肠息肉（异常组织生长）患者来调查大肠癌（结肠和直肠）。 患有这种疾病的人患息肉和大肠癌的风险增加。 息肉的通常治疗方法是在可能的情况下切除它们，或者仔细地进行结肠镜检查（一种用于观察肠道，直肠和结肠内部的程序）和活检（采集组织样本）。 进行活检以确保组织中没有提示癌症发展的变化。 大肠癌的发展与肠内壁中存在某些化学物质（多胺，三尖杉酯碱）有关。 本研究的目的是确定DFMO 500 mg（250 mg x 2）/天加舒林酸150 mg/天，每天口服，在36个月内是否会减少息肉的发展。 还将测量多胺和三尖杉酯碱的水平。 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。 本研究的参与者将被要求每天口服DFMO+舒林酸或安慰剂（非活性药物），共3年。 您将被分配到一个称为随机化的治疗过程中，这类似于抛硬币。 虽然局部DFMO是一种获批用于专门适应症的药物，但DFMO被视为一种研究药物（未被美国食品药品监督管理局批准用于医生的一般用途）。 舒林酸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。 通过美国的招募中心网络，约500例患者将入组本研究。'