Immunotherapy vs immuno-chemotherapy in patients with metastatic kidney carcinoma

INTERVENTION: 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) Concentration type: equal Concentration number: 18000000‐ Trade Name: GEMZAR*INFUS 1FL 1G POLV Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Gemcitabine CAS Number: 122111‐03‐9 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1000‐ Trade Name: NAVELBINE 50*IV 50MG 5ML Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Vinorelbine CAS Number: 122111‐03‐9 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50‐ CONDITION: metastatic kidney carcinoma ; MedDRA version: 6.1 Level: HLT Classification code 10038408 PRIMARY OUTCOME: Main Objective: To estimate if the addition of Gemcitabine and Navelbine leads to increase of activity and therapeutic efficacy with respect to immunotherapy alone 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 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 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