The efficacy of an antigenic marker lesion for the therapeutic effect in patients with multiple, Ta/T1, G1/G2, non-muscle invasive bladder cancer (NMIBC) treated with TUR followed by IL-2 instillation - Incomplete TUR and IL-2

VUmc Dept Urology0 个研究点开始时间: 2010年10月12日最近更新: 2012年3月19日

试验速览

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•Patients with a multiple (< 10) resectable Ta(G1,2) or T1(G1,2) transitional cell carcinoma of the bladder as diagnosed by pathological examination.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•- Excluded are patients with CIS, or a cancer type other than urothelial cell carcinoma, or with a second malignancy (except treated basal carcinoma of the skin), or a tumour in the prostatic urethra or in a diverticulum or in the upper urinary tract.
•- Patients who received local or systemic chemotherapy within 3 months before inclusion, or BCG within 6 months of inclusion, or any prior treatment with IL-2.
•- Patients who received local radiotherapy for any muscle invasive bladder cancer.
•- Patients who have recurrent severe bacterial or drug-induced cystitis.
•- Patients that received less than 3 months earlier systemically applied immune suppressive drugs.
•- Patients who require or are likely to require corticosteroids systemically or locally in the bladder or kidney for intercurrent disease.
•- HIV positive patients
•- Pregnancy or lactation. Or the patient is likely to become pregnant within 2 months after TUR.

发起方

VUmc Dept Urology