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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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-020397-42-NL
Enrollment
Unknown
Registered
2010-10-12
Start date
2010-12-22
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Trade Name: Proleukin Product Name: NA Product Code: NA Pharmaceutical Form: Powder for solution for infusion

Sponsors

VUmc Dept Urology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with a multiple (=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Main Objective: To demonstrate that treatment of non-muscle invasive bladder carcinoma with incomplete TUR and Il-2 is therapeutically more effective than treatment with complete TUR and IL-2;Secondary Objective: To establish the mechanism of action of incomplete TUR in combination with IL-2 instillations in patients with multiple, Ta / T1, G1 / G2, non-muscle invasive bladder carcinoma.;Primary end point(s): 1. The recurrence-free period after intervention. 2. The percentage of recurrence-free patients 2 years after intervention. 3. The percentage of complete regression of the marker tumours 3 months after intervention.—

Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026