NCT02281383已完成2 期
Phase II Study to Evaluate the Response to 2 Induction Courses (12 Intravesical Instillations) of Bacillus Calmette-Guérin (BCG) for High Risk Superficial Bladder Cancer
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 8
- 主要终点
- Response Rate
研究概览
简要总结
This is a phase II study. This means that BCG therapy has already been found to be safe in humans. The investigators just want to see if using more treatments works better.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have high risk non-muscle invasive urothelial bladder carcinoma (Tis, TaHG, or T1) that is pathologically confirmed by the Memorial Sloan Kettering Department of Pathology or a documented history of TaHG or T1 non-muscle invasive urothelial bladder tumors.
- •18 years and older
- •All visible papillary lesions must be macroscopically resected within 60 days of treatment initiation.
- •Absence of urothelial carcinoma involving the upper urinary tract (documented by radiological imaging or biopsy) preferably within 12 months from the start of treatment. Should the imaging or biopsy be performed outside this window it will be up to the physicians discretion to re-scan/biopsy.
- •Patients who have received a single dose of mitomycin C following staging TUR.
排除标准
- •Currently being treated or scheduled to have radiation treatment for bladder cancer during the study.
- •Treatment with intravesical BCG or chemotherapy for a patient's current <T2 tumor during the 12 months prior to the current diagnosis.
- •Currently being treated or scheduled to have treatment with any systemic or intravesical chemotherapeutic agent during the study.
- •Currently being treated with or having been treated in the last 12 months with any investigational drug for high risk superficial bladder cancer.
- •Previous muscle-invasive (i.e., stage T2 or higher) transitional cell carcinoma of the bladder.
- •Currently being treated for metastatic transitional cell carcinoma.
- •Scheduled to have surgery for bladder cancer during the study.
- •Presence of clinically significant infections or congenital or acquired immunodeficiency.
结局指标
主要结局
Response Rate
时间窗: 6 months
(by cystoscopy and cytology) Participants who have a response are those who have no evidence of disease in their bladder by both urine cytology and cystoscopy. Participants whose disease remains at the same stage or is downstaged without complete resolution are considered nonresponders and will be documented as having recurred. Participants with worsening tumor, defined as the upstaging from non-muscle invasive to muscle invasive disease, or metastatic disease will be documented as disease progression.
次要结局
- Percentage of Participants With Recurrence-free Survival After Complete Response(2 years)
研究者
研究点 (8)
Loading locations...
相似试验
Unknown
2 期
HPTN 081 AMP StudyHIV/AIDSPACTR202005582198497Division of AIDS82
终止
1 期
NBE-002 in Patients With Advanced Solid TumorsAdvanced Solid TumorAdvanced CancerTriple Negative Breast CancerNCT04441099NBE-Therapeutics AG12
尚未招募
1 期
BC-101 in Treatment of Nasolabial Fold WrinklesNasolabial Fold WrinklesNCT05162326Bright Cell, Inc.9
进行中（未招募）
2 期
A study to test a new type of treatment for blood cancer. In this new treatment the blood cells ofpatients are modified to kill cancer cell on their own.CTRI/2022/03/041162Immuneel Therapeutics Private Limited
已完成
2 期
A Phase 2 study to assess the safety, immunogenicity and recommended dose of DS-5670a in Japanese healthy adultsJPRN-jRCT2071210086Inoguchi Akihiro80