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Vaccine with dendritic cells pulsed tumoral cell line or with autologue tumor in patients with kidney carcinoma - ND

Conditions
kidney carcinoma
MedDRA version: 6.1Level: PTClassification code 10038415
Registration Number
EUCTR2006-004751-38-IT
Lead Sponsor
OSPEDALE ONCOLOGICO DI BARI
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

1. Patients with hystologically proved MRCC
2. Good performance status
3. Life expectancy > 3 months
4. Absence of brain metastasis
5. Age < 70 years
Are the trial subjects under 18? yes
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Brain metastasis
2. Active infections

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Main Objective: 1. CHEMICAL: administration of the vaccine, clinical monitoring, clinical safety and efficacy, <br>2. BIOLOGICAL: methods of colture, evaluation of the biological efficacy,;Secondary Objective: 1. CHEMICAL: immunologic monitoring in vivo<br>2. BIOLOGICAL: critical and statistic evaluation of the results;Primary end point(s): Preparation of the vaccine antigenic format
Secondary Outcome Measures
NameTimeMethod
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