Open-label, Multi-center Study of the Efficacy and Safety of MCC in the Treatment of Patients With Non-muscle Invasive (Superficial) Bladder Cancer at High Risk of Progression and Who Are Refractory to BCG
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 129
- 试验地点
- 31
- 主要终点
- One year disease-free survival rate
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of intravesical Mycobacterial Cell Wall-DNA Complex (MCC) in patients with non-muscle invasive transitional cell carcinoma (papillary tumors and/or carcinoma in situ) of the urinary bladder at high risk of progression who are refractory to therapy with bacillus Calmette-Guerin (BCG).
详细描述
The study will be divided into 3 phases: Induction, Maintenance, and Follow-up.
The Induction Phase will cover a period of 6 weeks. During this time, patients will receive 6 weekly intravesical instillations of 8 mg MCC. The patients will be evaluated at month 3, at which time the patients will enter the Maintenance Phase. The Maintenance Phase will last from month 3 to month 24, and during this time, patients will receive weekly MCC instillations for three weeks at months 3, 6, 12, 18, and 24 and evaluations will be performed at months 3, 6, 9, 12, 15, 18, 21 and 24.
At month 3, the patient will be evaluated to assure that the disease is not progressing. Cytology, cystoscopy and biopsies will be performed to obtain adequate staging (if residual tumor persists). If the patient is disease-free, maintenance therapy will be initiated. Patients with non-muscle invasive tumors at month 3 will, at the discretion of the investigator, receive either a second 6-week induction course or a 3-week maintenance course. Patients who show progression to muscle invasive disease will be referred to other treatments.
At month 6 and thereafter at each evaluation visit, patients will be evaluated and managed according to the following results:
- Patients who are disease-free will continue on maintenance treatment.
- Patients who are not disease-free (evidence of papillary lesions, CIS or muscle invasive disease) will be withdrawn from further study treatment and will be referred to other therapies at the discretion of the investigator.
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 refractory to BCG therapy;
- •Patients with histologically confirmed diagnosis of high grade lesions;
- •Diagnosis of high grade lesion must be within 56 days prior to beginning of study treatment;
- •Have had all visible papillary lesion(s) resected by TURBT within 56 days prior to beginning of study treatment;
- •Available for the whole duration of the study including follow-up (60 months);
- •Life expectancy of > 5 years;
- •Patients with an ECOG performance status grade of 2 or less;
- •Absence of urothelial carcinoma involving the upper urinary tract or prostatic urethra within 12 months from beginning of study treatment;
- •Able to understand and give written informed consent;
- •In the investigator's judgment, the patient is able to participate in the study.
排除标准
- •Current or previous history of muscle invasive tumors;
- •Current or previous history of lymph node or distant metastases from bladder cancer;
- •Current systemic cancer therapy;
- •Current or prior pelvic external beam radiotherapy;
- •Pelvic brachytherapy within 2 years of study entry;
- •Prior treatment with MCC;
- •Patients with existing urinary tract infection or recurrent severe bacterial cystitis;
- •Clinically significant and unexplained elevations of liver or renal function tests;
- •White blood cell count below 3 x109/L (3,000/mm3) or platelet count below 100 x 109/L(100,000/mm3);
- •Severe cardiovascular disease;
- •Women who are pregnant or lactating;
- •Congenital or acquired immune deficiency;
- •With history of malignancy of any organ system, treated or untreated, within the past 5 years (with the exception of adequately treated basal cell or squamous cell carcinoma of the skin, stage T1 prostate cancer, carcinoma in situ of the cervix or colon polyps);
- •Previous investigational treatment within 3 months from beginning of study treatment;
- •Patients who cannot hold the instillation for one hour;
- •Patients who cannot tolerate intravesical administration or intravesical surgical manipulation (cystoscopy or biopsy);
- •Clinically significant active infections;
- •Any medical or psychiatric condition which, in the opinion of the investigator, would preclude the participant from adhering to the protocol or completing the trial per protocol.
研究组 & 干预措施
Mycobacterial cell wall-DNA complex
Mycobacterial cell wall-DNA complex
干预措施: Mycobacterial cell wall-DNA complex (Drug)
结局指标
主要结局
One year disease-free survival rate
时间窗: Prospective
次要结局
- Duration of disease-free survival in all patients(Prospective)
- Time to progression to muscle invasive disease(Prospective)
- Overall survival in all patients(Prospective)
- Rate of overall drug-related adverse events leading to two consecutive treatment delays of one week each or to the discontinuation of treatment.(Prospective)
- The 3, 6 and 24 month disease-free survival rate(Prospective)