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.
Clinical Trials /
DC Vaccine in Colorectal Cancer
NCT03730948
Related Conditions:
- Colorectal Carcinoma
Recruiting Status:
Recruiting
Phase:
Phase 1
Trial Eligibility
Document
Title
- Brief Title: DC Vaccine in Colorectal Cancer
- Official Title: Pilot Study of Mature Dendritic Cell Vaccination for Resected Hypermutated Colorectal Cancer
Clinical Trial IDs
- ORG STUDY ID: UPCC 16218, 831453
- NCT ID: NCT03730948
Conditions
- Colorectal Cancer
Interventions
| Drug | Synonyms | Arms |
|---|---|---|
| DC vaccine | All subjects |
Purpose
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.
Detailed 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.
Trial Arms
| Name | Type | Description | Interventions |
|---|---|---|---|
| All subjects | Experimental | All subjects will receive the vaccine and be followed per the schedule of procedures. |
|
Eligibility Criteria
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Changes in numbers of peptide-specific CD8+ T cells (post-vaccine immune response) |
| Time Frame: | Screening, Day 1, Day 43, Day 85. Also at following timepoints, which will vary by subject: 7-14 days after last vaccine; 30 days after last vaccine; every 3 months beginning 6 months since first vaccine until month 12. |
| Safety Issue: | |
| Description: | Numbers of peptide-specific CD8+ T cells will be measured by flow cytometric-based intracellular cytokine or tetramer staining |
Secondary Outcome Measures
| Measure: | Percentage of CD8+ cells in primary tumor tissue |
| Time Frame: | Screening, Day 1, Day 43, Day 85. Also at following timepoints, which will vary by subject: 7-14 days after last vaccine; 30 days after last vaccine; every 3 months beginning 6 months since first vaccine until month 12. |
| Safety Issue: | |
| Description: | Descriptive models |
Details
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | University of Pennsylvania |
Trial Keywords
- colorectal cancer
- cancer vaccine
- dendritic cell vaccine
Last Updated
December 17, 2020
