Dendritic Cell Vaccination in Patients With Lynch Syndrome or Colorectal Cancer With MSI (NCT01885702) | Clinical Trial Compass
UnknownPhase 1/2
Dendritic Cell Vaccination in Patients With Lynch Syndrome or Colorectal Cancer With MSI
Netherlands25 participantsStarted 2010-10
Plain-language 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 neoantigen-loaded DC of CRC patients with an MSI-positive CRC and persons who are known to be carrier of a germline MMR-gene mutation with no signs of disease yet.
The secondary objectives of the study are:
* to demonstrate that peptide-loaded DC can induce or enhance an immune response to tumor-associated antigen CEA and specific frameshift-derived neoantigens in the study population.
* to study the pathological and clinical responses, e.g. disease-free survival, determined according to the standard protocol.
Study design:
This study is a phase I/II open-label study.
Study population:
Two groups of adults will be vaccinated:
Group I) CRC patients, who are known to carry a germline MMR-gene mutation and patients with an MSI-positive CRC and yet unknown or negative MMR-gene mutation status.
Group II) persons who are known to be carrier of a germline MMR-gene mutation with no signs of disease yet. All participants need to be HLA-A2.1 positive.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and feasibility of vaccination with frameshift-derived neoantigen-loaded DC of CRC patients