Dendritic cell vaccination in patients with Lynch Syndrome or colorectal cancer with MSI

Completed

• Conditions: 10083624; 10017990; 10027656; hereditary non-polyposis colorectal cancer; Lynch syndrome

• Registration Number: NL-OMON39056
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 25

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 >3.0×109/l, lymphocytes >0.8×109/l, platelets >100×109/l, serum creatinine <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
* autoimmune diseases or organ allografts
* concomitant use of immunosuppressive drugs
* known allergy to shell fish
* pregnant or lactating women

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The first objective of this study is to evaluate safety and feasibility of<br /><br>vaccination with frameshift-derived neoantigen-loaded DC.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objectives of the study are to evaluate whether peptide-loaded DC<br /><br>can induce or enhance an immune response to tumor-associated antigen CEA and<br /><br>specific frameshift-derived neoantigens in the study population and the<br /><br>pathological and or clinical responses, e.g. disease-free survival, determined<br /><br>according to the standard protocol.</p><br>