Immunotherapy vs immuno-chemotherapy in patients with metastatic kidney carcinoma - ND

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-003746-42-IT

Enrollment

210

Registered

2006-10-03

Start date

2003-02-11

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

metastatic kidney carcinoma MedDRA version: 6.1 Level: HLT Classification code 10038408

Interventions

Trade Name: PROLEUKIN*EV 1FL 18MUI 5ML Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Aldesleukin CAS Number: 110942-02-4 Concentration unit: IU international unit(s)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologic diagnosis of kidney carcinoma 2. Presence of metastases and/or locally advanced primary tumour 3. Age 18 years old 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. Severe infections 2. Previous treatment with IL-2 3. Brain metastasis 4. Pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: To estimate if the addition of Gemcitabine and Navelbine leads to increase of activity and therapeutic efficacy with respect to immunotherapy alone;Secondary Objective: 1. To estimate the toxicity of the two treatments 2. To estimate the treatment impact on the patient s life quality 3. To find the meaning of some predictive factors VES, PCR, LDH, total lymphocytes ;Primary end point(s): To estimate if immunotherapy with IL-2, Gemcitabina e Navelbine is more effective with respect to immunotherapy alone in patients with kidney carcinoma	—

Measure

Time frame

Main Objective: To estimate if the addition of Gemcitabine and Navelbine leads to increase of activity and therapeutic efficacy with respect to immunotherapy alone;Secondary Objective: 1. To estimate the toxicity of the two treatments 2. To estimate the treatment impact on the patient s life quality 3. To find the meaning of some predictive factors VES, PCR, LDH, total lymphocytes ;Primary end point(s): To estimate if immunotherapy with IL-2, Gemcitabina e Navelbine is more effective with respect to immunotherapy alone in patients with kidney carcinoma

—

Countries

Italy

Outcome results

None listed

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