Study of the efficacy of intravesical instillations of interleukin-2 in treatment of superficial bladder cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-002821-30-LT

Enrollment

Registered

2004-10-11

Start date

2004-12-09

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

Ta,T1 /G1,G2,G3 superficial bladder cancer MedDRA version: 9.1 Level: LLT Classification code 10005003 Term: Bladder cancer

Interventions

Product Name: Proleukin Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: Aldesleukin Other descriptive name: Interleukin-2 Concentration unit: IU/ml international unit(s)/mil

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Signed patient informed consent form 2. Histologically confirmed diagnosis of multifocal Ta,T1 /G1,G2 superficial bladder cancer 3. WHO-performance status 0-2 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

Exclusion criteria: 1. The presence of a cancer type other than transitional cell carcinoma 2. Previous intravesical chemotherapy within 3 months before treatment 3. Previous radiotherapy to the bladder 4. Urinary tract infection 5. Decompensated cardiovascular, renal or liver diseases

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the therapeutic effect of intravesical instillations of IL-2 after transurethral resections (TUR) for recurrence-free survival in patients with Ta,T1 /G1,G2, G3 superficial bladder carcinoma ;Secondary Objective: 1.To determine the significance of biomarkers (immunologic, genomic, proteomic) for the therapeutic effect of IL-2 2.To determine possible side effects. ;Primary end point(s): Recurrence-free survival	—

Measure

Time frame

Main Objective: To determine the therapeutic effect of intravesical instillations of IL-2 after transurethral resections (TUR) for recurrence-free survival in patients with Ta,T1 /G1,G2, G3 superficial bladder carcinoma ;Secondary Objective: 1.To determine the significance of biomarkers (immunologic, genomic, proteomic) for the therapeutic effect of IL-2 2.To determine possible side effects. ;Primary end point(s): Recurrence-free survival

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Countries

Lithuania

Outcome results

None listed

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