Phase I/II clinical trial:Immunotherapy of hormone-refractory prostate cancer patients with dendritic cell-based vaccine (Fáze I/II klinické studie imunoterapie hormonálne refrakterního karcinomu prostaty pomocí vakcinace dendritickými bunkami) - Imunoterapie karcinomu prostaty dendritickými bunkami
- Conditions
- Patients with hormone-refractory prostate cancer
- Registration Number
- EUCTR2009-017295-24-CZ
- Lead Sponsor
- niversity Hospital Motol
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- Not specified
Inclusion Criteria
Histological confirmed prostatic adenocarcinoma
Progression of PSA serum concentration after the failure of second line hormonal therapy in generalized disease
Karnofsky performance status more than 80%
Signed informed consent
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
HIV positivity, active B or C hepatitis
Severe cardiac or other internal disease limiting patient survival
History of primary immunodeficiency, active autoimmunity requiring tratment or anaphylactic reaction after previous vaccination
Negative informed consent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Safety and toxicity;Secondary Objective: Immunological and biochemical responses;Primary end point(s): Evaluation of adverse reaction to the vaccination with DC, immunological and biochemical response to vaccine
- Secondary Outcome Measures
Name Time Method