Immunotherapy vs immuno-chemotherapy in patients with metastatic kidney carcinoma - ND
- Conditions
- metastatic kidney carcinomaMedDRA version: 6.1Level: HLTClassification code 10038408
- Registration Number
- EUCTR2006-003746-42-IT
- Lead Sponsor
- OSPEDALE ONCOLOGICO DI BARI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 210
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
1. Severe infections 2. Previous treatment with IL-2 3. Brain metastasis 4. Pregnancy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method