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

• Conditions: Multiple, Ta / T1, G1 / G2, non-muscle invasive bladder carcinoma

• Registration Number: EUCTR2010-020397-42-NL
• Lead Sponsor: VUmc Dept Urology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified