Status:
ACTIVE_NOT_RECRUITING
Dendritic Cell Vaccination in Patients With Lynch Syndrome or Colorectal Cancer With MSI
Lead Sponsor:
Radboud University Medical Center
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
Objectives: In this Radboud University Nijmegen Medical Centre (RUNMC) initiated study our first objective is to investigate toxicity (safety and feasibility) of vaccination with frameshift-derived n...
Detailed Description
Rationale of this study: Ex vivo generated and tumor-antigen-loaded dendritic cells (DC) are currently used in clinical vaccination protocols in cancer patients. DC vaccines are safe, with minimal si...
Eligibility Criteria
Inclusion
- histologically documented evidence of CRC (group I) and Lynch syndrome carrier without signs of disease (group II)
- HLA-A2.1 phenotype is required
- MSI high tumor
- WBC \>3.0 x 109/l, lymphocytes \>0.8 x 109/l, platelets \>100 x 109/l, serum crea¬tinine \<150 µmol/l, serum bilirubin \<25 µmol/l
- WHO performance status 0-1 (Karnofsky 100-70%)
- Age 18-75 years
- Expected adequacy of follow-up
- Written informed consent
Exclusion
- History of malignancy in the past 5 years with the exception of adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix
- Serious active infections, HbsAg or HIV positive (test only in case of high risk or clinical suspicion)
- Autoimmune diseases or organ allografts
- Concomitant use of immunosuppressive drugs
- Known allergy to shell fish
- Pregnant or lactating women
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01885702
Start Date
October 1 2010
End Date
September 1 2025
Last Update
April 4 2025
Active Locations (1)
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1
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands, 6500 HB