NCT01878188已完成1 期
Phase I Study of BC-819/PEI and BCG in Patients With Superficial Transitional Cell Bladder Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 7
- 主要终点
- Safety and tolerability of three regimens of intravesically administered BC-819/PEI and BCG by number of subjects with AEs and change from baseline for clinical safety laboratory tests
研究概览
简要总结
- Safety and tolerability of three regimens of intravesically administered BC-819/PEI and BCG (number of participants with AEs, discontinuations due to AEs)
- Recurrence after treatment with BC-819/PEI and BCG
- Approximately 38 patients with superficial transitional cell carcinoma TCC) of the bladder
- After initial evaluation and qualification, patients will be randomized to one of three treatment groups, either alternating, sequential or twice weekly
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 with superficial papillary transitional cell carcinoma of the bladder for whom BCG is clinically indicated. If CIS is present, diagnosis needs to be confirmed by biopsy prior to the start of the study.
- •Males or females more than 18 years old
- •All papillary tumors must be resected within 8 weeks prior to the start of study therapy.
- •ECOG performance status 2 or less.
- •Adequate hematologic function, as demonstrated by
- •Hemoglobin 10 g/dL or higher
- •ANC 1.5 x 109/L or higher
- •Platelets higher than 100 x 109/L
- •Adequate liver and renal function as demonstrated by
- •AST and ALT each 3.0 x ULN or less
- •Total bilirubin 1.5 x ULN or less
- •Creatinine 1.5 X ULN OR less, creatinine clearance >60 mL/min
- •If fertile and sexually active, must use adequate contraception
- •Must be able to comply with protocol requirements, including attendance at required clinic visits.
- •Patients must provide written informed consent.
排除标准
- •Patients who are candidates for either partial or total bladder resection, unless either medically contraindicated or who have refused surgery.
- •Patients with a tumor in a diverticulum, in the prostatic urethra, or covering the ureteral orifice.
- •Patients who have received cytotoxic drugs, systemic corticosteroids or any investigational drug for any indication within 4 weeks of the start of protocol treatment.
- •Patients who have received any intravesical therapy other than surgical resection within 8 weeks prior to the start of protocol treatment.
- •Patients who have received radiation therapy for bladder cancer at any time or for any condition within 4 months prior to the start of protocol treatment.
- •Patients who have active infections, including urinary tract infections, whether viral, bacterial or fungal and requiring therapy.
- •Patients who are receiving coumadin.
- •Patients who have had to discontinue a past course of BCG due to toxicity.
- •Patients who are having urinary tract signs or symptoms from recent urinary tract procedures or manipulations, such as biopsies or catheterizations.
- •Patients who are known to be HIV positive.
- •Females who are pregnant or breast feeding.
- •Presence of any medical, psychological or social condition or situation which may, in the investigator's opinion, make it difficult for the patient to tolerate study medication or comply with study procedures and other requirements. This includes but is not limited to active infections, poorly controlled diabetes, uncontrolled cardiac arrhythmias, angina pectoris, or hypertension.
研究组 & 干预措施
BC-819/PEI and BCG alternating
Experimental
4 or 6 weekly treatments of BC-819/PEI alternating with 6 treatments of BCG
干预措施: BC-819/PEI (Drug)
BC-819/PEI and BCG alternating
Experimental
4 or 6 weekly treatments of BC-819/PEI alternating with 6 treatments of BCG
干预措施: BCG Vaccine (Drug)
BC-819/PEI and BCG Vaccine sequential
Experimental
4 weekly treatments of BC-819/PEI followed by 6 weekly treatments of BCG
干预措施: BC-819/PEI (Drug)
BC-819/PEI and BCG Vaccine sequential
Experimental
4 weekly treatments of BC-819/PEI followed by 6 weekly treatments of BCG
干预措施: BCG Vaccine (Drug)
twice-weekly treatments of BC-819 and BCG
Experimental
6 twice-weekly treatments of BC-819/PEI and BCG
干预措施: BC-819/PEI (Drug)
twice-weekly treatments of BC-819 and BCG
Experimental
6 twice-weekly treatments of BC-819/PEI and BCG
干预措施: BCG Vaccine (Drug)
结局指标
主要结局
Safety and tolerability of three regimens of intravesically administered BC-819/PEI and BCG by number of subjects with AEs and change from baseline for clinical safety laboratory tests
时间窗: 3 months
次要结局
- Recurrence of bladder cancer after treatment with BC-819/PEI and BCG(3 months)
研究者
研究点 (7)
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