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DC Vaccine in Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT03730948
Recruitment Status : Recruiting
First Posted : November 5, 2018
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Biological: DC vaccine Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Mature Dendritic Cell Vaccination for Resected Hypermutated Colorectal Cancer
Actual Study Start Date : March 12, 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: All subjects
All subjects will receive the vaccine and be followed per the schedule of procedures.
Biological: DC vaccine
DC vaccine for colorectal cancer




Primary Outcome Measures :
  1. 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. ]
    Numbers of peptide-specific CD8+ T cells will be measured by flow cytometric-based intracellular cytokine or tetramer staining

  2. Adverse events experienced by subjects (i.e. safety of DC vaccine in subjects with surgically resected hypermutated CRC) [ Time Frame: Through study completion (at 12 months) ]
    Review of adverse events experienced by subjects


Secondary Outcome Measures :
  1. 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. ]
    Descriptive models



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03730948


Contacts
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Contact: Emerging Medicine 855.216.0098 PennCancerTrials@emergingmed.com

Locations
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United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Kim Reiss-Binder, MD    215-360-0735    Kim.ReissBinder@uphs.upenn.edu   
Contact: Emerging Medicine    855-216-0098    PennCancerTrials@emergingmed.com   
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Kim Reiss-Binder, MD University of Pennsylvania

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03730948     History of Changes
Other Study ID Numbers: UPCC 16218, 831453
First Posted: November 5, 2018    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Pennsylvania:
colorectal cancer
cancer vaccine
dendritic cell vaccine
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs