Mature Dendritic Cell Vaccine in Treating Patients with Stage I-II Resected Hypermutated Colorectal Cancer

Inclusion Criteria

• Pathologically-confirmed stage I and II hypermutated colorectal cancer (CRC). Hypermutated CRC is defined by one of the following categories: * Microsatellite instability-high (MSI-H) by polymerase chain reaction (PCR). MSI-H is defined as two or more of the five markers for microsatellite instability being positive. These markers are: BAT25, BAT26, D2S123, D5S346 and D17S250 * Mismatch repair deficient (MMRd) as defined by loss of expression of mismatch repair (MMR) protein(s) (MLH1, MSH2, MSH6, and/or PMS2) on MMR immunohistochemistry (IHC), which includes hereditary syndromes such as Lynch syndrome and congenital mismatch repair deficiency (CMMRD) as well as CRCs with somatic MMRd * Those arising in patients with polymerase proofreading associated polyposis (PPAP) with inherited mutations in either POLE or POLD1. (Hypermutated malignancies including CRC typically harbor > 10 mutations/mutational burden [Mb])
• Surgically resected disease
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• White blood cells (WBC) > 3 THO/uL (within 14 days prior to eligibility confirmation by physician-investigator)
• Hemoglobin (Hg) >= 9.0 gm/dl (within 14 days prior to eligibility confirmation by physician-investigator)
• Platelets > 75 THO/uL (within 14 days prior to eligibility confirmation by physician-investigator)
• Serum total bilirubin < 2.0 mg/dl (within 14 days prior to eligibility confirmation by physician-investigator)
• Serum creatinine < 2.0 mg/dl (within 14 days prior to eligibility confirmation by physician-investigator)
• Subjects of reproductive potential must agree to use a medically accepted birth control method during the trial and for at least two months following the trial
• Provide written informed consent

Exclusion Criteria

• Prior malignancy within 3 years that, in opinion of the physician-investigator, would put subject at additional risk
• Pregnant or nursing (lactating) women
• Concurrent treatment with systemic immunosuppressants including corticosteroids (e.g prednisone), calcineurin inhibitors (e.g tacrolimus, cyclosporine), antiproliferative agents (e.g mycophenolate mofetil, azathioprine) within 2 weeks of eligibility confirmation by physician-investigator. Local (inhaled or topical) steroids or replacement dose prednisone (=< 10 mg daily) are permitted
• Known allergy to eggs
• Any uncontrolled intercurrent illness or active ongoing infection that, in the opinion of the physician-investigator, would put the subject at additional risk