A Phase 1 Study of the Safety and Tolerability of Intravesical Administration of SCH 721015 in Patients With Transitional Cell Carcinoma of the Bladder
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 主要终点
- Adverse events, laboratory safety tests, dose-limiting toxicity
研究概览
简要总结
The purpose of this first-in-human study is to determine the safety and tolerability of SCH 721015 in subjects with transitional cell carcinoma of the bladder.
详细描述
A nonrandomized, open-label, rising-dose, parallel-group, multi-center study of SCH 721015 in patients with papillary bladder cancer, or carcinoma in situ that is refractory to Bacillus Calmette-Guerin. Subjects will receive a single intravesical administration of SCH 721015 with SCH 209702 in a total volume of 75 mL with a 1-hour dwell time. Subjects who at 3 months post administration demonstrate a complete response (CR on cystoscopy/biopsy and cytology) and who did not experience dose-limiting toxicity will be allowed to receive a second intravesical administration at the same dose level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Histologically proven recurrent transitional cell carcinoma of the bladder, Stage Tis, Ta.
- •Patients with recurrent T1 disease who do not wish to have cystectomy.
- •Subjects must have failed at least two prior courses of BCG with or without recombinant interferon alpha administration.
- •At least 3 months must have passed since last intravesical treatment for bladder carcinoma.
- •Subjects must be 18 years of age or older.
- •Life expectancy of at least 3 months.
- •Adequate performance status (Karnofsky score >=70%).
- •Adequate laboratory values.
排除标准
- •Suspected hypersensitivity to interferon alpha.
- •Subjects with organ transplants.
- •Any known preexisting medical condition that could interfere with the subject's participation in and completion of the study such as:
- •History of psychosis or presence of poorly controlled depression;
- •CNS trauma or active seizure disorders requiring medication;
- •Significant cardiovascular dysfunction within the past 6 months including symptomatic cardiac ischemia, arrhythmia or congestive heart failure requiring hospitalization or emergency room visit within last 3 months;
- •Poorly controlled diabetes mellitus (HbA1C >10.0%);
- •Unstable chronic pulmonary disease requiring hospitalization or emergency room visit within the last 3 months;
- •Immunologically mediated disease (eg, rheumatoid arthritis, autoimmune hepatitis, immune mediated glomerulonephritis).
- •History of any clinically significant local or systemic infectious disease within 4 weeks prior to initial treatment administration.
- •Untreated bladder infection.
- •Positive for hepatitis BsAg or HIV Ab or hepatitis C.
- •Immunosuppressive therapy within the last 3 months.
- •BCG therapy or intravesical therapy within 3 months.
- •Traumatic catheterization within 1 month.
结局指标
主要结局
Adverse events, laboratory safety tests, dose-limiting toxicity
时间窗: ECG and VS - predose and selected postdose time points.
次要结局
- Timed urine collections for IFNα2b excretion & IP-10.(Days 1-7, 10, 14, 21, & 28/29.)
- Urine samples for SCH 721015 DNA content.(Predose, Days 1-7 & 14.)
- Blood samples for SCH 721015 DNA; SCH 209702, & IFNα2b levels; antiadenoviral & anti-IFNα2b antibodies(Pre- & postdose for SCH 721015 DNA; SCH 721015, & IFNα2b levels; & postdose for antibodies.)
- Urine cytology & FISH(Days 1, 30 & 90)
- Cystoscopy & bladder biopsies(Screening & Day 90)