Adjuvant Sequential Intravesical BCG (Bacillus Calmette-Guérin) and Electromotive Mitomycin-C (EMDA/MMC) After Transuretheral Resection (TUR) in Patients With Primary High Risk Non-Muscle Invasive Transitional Cell Carcinoma of the Bladder
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 4
- 主要终点
- To Assess Disease Recurrence Rate
研究概览
简要总结
The primary objective of the study is to assess the bladder cancer recurrence free rate, according to a phase II pilot study, of intravesical instillation of sequential BCG and EMDA/MMC after TUR. The study is designed as a one-sample investigation: the outcome measure is disease recurrence rate. Follow up will continue up to 5 years.
For sample size determination, disease recurrence rate will be compared with literature data of recurrence rate obtained in standard BCG alone administration (Lamm's protocol).
详细描述
TURBT (TransUrethral Resection of Bladder Tumor)
Prior to enrolment, all patients must sign a consent form and will have a Complete Blood Count (CBC), Basic Metabolic Panel (BMP) and a Urinalysis (UA) performed. The patients White Blood Count (WBC) must be greater than 4.0 10^9/L and platelet count greater than 150 10^9/L to receive drug.
Week 1, 2, 4, 5, 7 and 8: BCG instillation: 50 mg wet weight (10•2±9•0x108 colony-forming units) BCG Connaught substrain. Lyophilised (ie, freeze-dried) BCG are suspended in 50 ml bacteriostatic-free 0.9% Sodium Chloride (NaCl) solution. After bladder draining, the suspension is infused intravesically through a 14 Fr Foley catheter and retained in the bladder for 60-90 min; bladder emptying is followed by catheter removal.
Week 3, 6 and 9: A Foley catheter is inserted and the bladder is carefully drained. 40 mg MMC dissolved in 100 ml NaCl 0.9% solution are instilled intravesically through the electrode catheter by gravity and retained in the bladder for 30 min, while 23 mA for 30 min pulsed electric current is given externally. Two dispersive cathode electrodes are placed on lower abdominal skin after degreasing with alcohol. The bladder is then emptied and the catheter removed. Patients are assigned one course of treatment per week for 6 weeks with sequential BCG and EMDA/MMC. Two BCG instillations and one EMDA/MMC instillation constitute one cycle for a total of two cycles.
A CBC and basic metabolic panel (BMP) will be performed weekly and at the beginning of each cycle. Prior to dosing with mitomycin C at week 3, a CBC will be performed and also at weeks 4 and 5 if the CBC has changed. A UA will be performed prior to each intravesicular instillation.
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 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •After a restaging TURBT patients with histologically proven primary high grade (grade3) and/or pT1 transitional cell carcinoma of the bladder, with or without pTis and pTis alone are regarded as being at high risk for tumour recurrence and progression.
- •Patients may enroll in this study if they are thought to have no residual disease after TURBT.
- •Age 18 years or over
- •Adequate bone-marrow reserve- ECOG performance status between 0 and 2
- •Patients who are known PPD positive will be screened for active tuberculosis prior to starting treatment with BCG.
排除标准
- •known allergy to BCG or MMC
- •prior systemic infection with BCG
- •prior or concomitant urothelial tumours of the upper urinary tract or urethra
- •previous muscle-invasive (ie, stage T2 or higher) transitional-cell carcinoma of the bladder
- •bladder capacity of less than 200 ml
- •untreated urinary-tract infection
- •severe systemic infection (ie, sepsis)
- •known HIV-positivity; therapy with immunosuppressive agents
- •urethral strictures that would prevent endoscopic procedures and repeated catheterisation
- •upper urinary tract disease (eg, vesicoureteral reflux or urinary-tract stones) that would make multiple transurethral procedures a risk
- •previous radiotherapy to the pelvis
- •other concurrent chemotherapy
- •treatment with radiotherapy-response or biological-response modifiers
- •history of tuberculosis;
- •other malignant diseases within 5 years of trial registration (except for adequately treated basal-cell or squamous cell skin cancer, in situ cervical cancer and any other cancer from which patients has been disease-free for 3 years);
- •pregnancy or nursing
- •psychological, familial, sociological, or geographical factors that would preclude study participation.
- •Patients with implantable or wearable electrical devices will be excluded from this study.
- •Patients with active tuberculosis
研究组 & 干预措施
Intravesical BCG and EMDA/MMC
Patients are assigned one course of treatment per week for 6 weeks of Intravesical Intravesical BCG and EMDA/MMC
干预措施: Intravesical BCG and EMDA/MMC (Device)
结局指标
主要结局
To Assess Disease Recurrence Rate
时间窗: 5 years
次要结局
- To Compare Complete Response Rates at 3 and 6 Months in Patients With Carcinoma in Situ.(5 years)