DC Vaccine in Colorectal Cancer
Status and phase
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Details and patient eligibility
About
This is a pilot study to assess the safety and tolerability, as well as the immune response rate, of mDC3 vaccine in patients with colorectal cancer.
Full description
This is a pilot study to assess the safety and tolerability, as well as the immune response rate, of mDC3 vaccine in patients with colorectal cancer.
Eligible patients that provide written informed consent will undergo apheresis to collect blood mononuclear cells for vaccine production approximately 1 week prior to vaccine infusion. Each study subject will receive cyclophosphamide 300mg/m^2 intravenously 3 to 4 days prior to the vaccine dose to deplete regulatory T cells. For each vaccine dose, all subjects will receive autologous dendritic cells pulsed with mutated peptides. On Day 1, the subject will receive the primer vaccine dose; this will be followed by one booster vaccine dose approximately 8 weeks later. Peripheral blood will be taken weekly, and a second apheresis procedure will be performed at the end of study to monitor the immune response to the vaccine. Information will be gathered from usual clinic visits for approximately 1 year following the End of Treatment Study Visit to evaluate for disease progression.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Pathologically-confirmed stage I and II hypermutated colorectal cancer (CRC)
- Surgically resected disease
- Male or female patients 18+ years of age
- ECOG performance status 0-1
- Certain laboratory values, performed within 14 days prior to consent
- 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 may put subject at risk
- Pregnant or nursing women
- Concurrent treatment with systemic immunosuppressants including corticosteroids, calcineurin inhibitors, antiproliferative agents within 2 weeks of consent. Local (inhaled or topical) steroids or replacement dose prednisone are permitted.
- Known allergy to eggs
- Any uncontrolled intercurrent illness or active ongoing infection thta may put subject at additional risk
Trial design
Primary purpose
Allocation
Interventional model
Masking
4 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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