DC Vaccine in Colorectal Cancer
Primary Purpose
Colorectal Cancer
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
DC vaccine
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring colorectal cancer, cancer vaccine, dendritic cell vaccine
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
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
All subjects
Arm Description
All subjects will receive the vaccine and be followed per the schedule of procedures.
Outcomes
Primary Outcome Measures
Changes in numbers of peptide-specific CD8+ T cells (post-vaccine immune response)
Numbers of peptide-specific CD8+ T cells will be measured by flow cytometric-based intracellular cytokine or tetramer staining
Adverse events experienced by subjects (i.e. safety of DC vaccine in subjects with surgically resected hypermutated CRC)
Review of adverse events experienced by subjects
Secondary Outcome Measures
Percentage of CD8+ cells in primary tumor tissue
Descriptive models
Full Information
NCT ID
NCT03730948
First Posted
October 30, 2018
Last Updated
July 25, 2023
Sponsor
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT03730948
Brief Title
DC Vaccine in Colorectal Cancer
Official Title
Pilot Study of Mature Dendritic Cell Vaccination for Resected Hypermutated Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
Lack of enrollment
Study Start Date
March 12, 2019 (Actual)
Primary Completion Date
February 22, 2022 (Actual)
Study Completion Date
December 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colorectal cancer, cancer vaccine, dendritic cell vaccine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
All subjects
Arm Type
Experimental
Arm Description
All subjects will receive the vaccine and be followed per the schedule of procedures.
Intervention Type
Biological
Intervention Name(s)
DC vaccine
Intervention Description
DC vaccine for colorectal cancer
Primary Outcome Measure Information:
Title
Changes in numbers of peptide-specific CD8+ T cells (post-vaccine immune response)
Description
Numbers of peptide-specific CD8+ T cells will be measured by flow cytometric-based intracellular cytokine or tetramer staining
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.
Title
Adverse events experienced by subjects (i.e. safety of DC vaccine in subjects with surgically resected hypermutated CRC)
Description
Review of adverse events experienced by subjects
Time Frame
Through study completion (at 12 months)
Secondary Outcome Measure Information:
Title
Percentage of CD8+ cells in primary tumor tissue
Description
Descriptive models
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim Reiss-Binder, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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DC Vaccine in Colorectal Cancer
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