BEAUMONT/FORD INTERSTITIAL CYSTITIS CLINICAL CENTER

说明（申请摘要） 博蒙/亨利福特间质性膀胱炎（IC）的目的 临床中心是（1）提供经验丰富的临床中心， 与其他IC中心和数据协调中心协作， 进行临床试验治疗IC患者，（2）进行 前瞻性随机安慰剂对照试验比较膀胱内BCG 在接受膀胱内多硫酸戊聚糖（PPS）预治疗的IC患者中 或安慰剂，（3）进行初步（试点）研究，以重新诱导IC 初次膀胱内BCG治疗失败的患者， 膀胱内BCG诱导。 第一个临床试验将测试 假设在膀胱灌注PPS之前， 与膀胱内灌注相比， BCG单独 PPS对BCG膀胱灌注治疗的增效作用 据信是由于BC与PPS的牢固附着，PPS与 膀胱粘膜内层。 通过增加BCG与 膀胱，我们推测BCG的免疫效应可能增强。 第二项临床试验将检验以下假设： 对BCG无应答者进行膀胱内BCG治疗将使其中50例转化为 反应者，与原位癌患者的反应率相似， 接受再诱导卡介苗治疗。 假设第二种疗法 将增强这些无应答者的初始免疫力。 的 博蒙/亨利福特中心将为NIH试验组提供一个团队， 研究者在临床合作研究中有丰富的经验， 已成为IC数据库的一部分，并有成功招聘的良好记录 和保留IC科目。 该团队拥有临床试验方面的专业知识 特别是BCG在IC治疗中的应用。 如果拟议的 试验证明是成功的，我们将配备一个高效， IC的持久治疗。 联合治疗也可能 减少BCG用量，降低成本，降低潜力 这个治疗方案的发病率。

DESCRIPTION (Abstract of the application) The objectives of the Beaumont/Henry Ford interstitial cystitis (IC) clinical center are (1) to provide an experienced clinical center that will collaborate with the other IC centers and the data coordinating center to conduct clinical trials for treating patients with IC, (2) to conduct a prospective randomized placebo controlled trial comparing intravesical BCG in patients with IC pretreated with intravesical pentosan Polysulfate (PPS) or placebo, (3) to perform a preliminary (pilot) study to reinduce IC patients who failed the initial intravesical BCG therapy with a second induction of intravesical BCG. The first clinical trial will test the hypothesis that pretreatment of the bladder with intravesical PPS prior to instillation of BCG will increase the response rate compared to intravesical BCG alone. The enhancing effect of PPS on intravesical BCG treatment is believed to be due to strong attachment of BC to PPS, which binds tightly to the bladder mucosal lining. By increasing the binding of BCG to the bladder, we hypothesize that the immunologic effect of BCG may be enhanced. The second clinical trail will test the hypothesis that re-induction of intravesical BCG therapy to BCG non-responders will convert 50 of these to responders, similar to the response rate of carcinoma-in-situ patients who receive a reinduction BCG therapy. It is assumed that the second therapy will enhance the initial immunity conferred to these non-responders. The Beaumont/Henry Ford center will provide the NIH trial group a team of investigators experienced in clinical collaborative research as they have been part of the IC Data Base with a proven record of successful recruitment and retention of IC subjects. The team has expertise in clinical trials specifically in the use of BCG in the treatment of IC. If the proposed trials prove to be successful, we will be armed with a highly effective and durable treatment for IC. The combination therapy will also potentially reduce the dos of BCG, which will lower the cost and decrease the potential morbidity of this treatment program.