Generation of large-scale mature, monocyte-derived dendritic cells from adult cancer patients for the development of dendritic cell anti-cancer immunotherapy.
- Conditions
- cancercarcinomaneoplasm1001799010017991
- Registration Number
- NL-OMON32620
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 6
Inclusion Criteria
histologically confirmed PC/EAC
karnofsky performance status >60%
patient must be eligible to undergo leukapheresis (see inclusion criteria in protocol)
patient must have signed written consent
Exclusion Criteria
infection with hepatitis B, hepatitis C, HIV, HTLV and/or T. Pallidum
severe hyperbilirubinemia, leukopenia, anaemia (see exclusioncriteria in protocol)
karnofsky performance status <60%
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1. To determine if the vaccine meets the following releasecriteria: sterility,<br /><br>maturation state, phenotype and migratory<br /><br>capacity of the DCs<br /><br>2. Determination of the amount of functional DCs obtained from 1 leukapheresis<br /><br>3. Determination of the immunopotency of the DC vaccines by performing an IFN*<br /><br>ELISPOT assay.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Not applicable</p><br>