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DC Vaccine in Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03592888
Recruitment Status : Recruiting
First Posted : July 19, 2018
Last Update Posted : April 6, 2023
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Study Description
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Brief Summary:
This research study is designed to evaluate the effects of a dendritic cell (kind of white blood cell) vaccine for pancreatic cancer.

Condition or disease Intervention/treatment Phase
Pancreatic Ductal Adenocarcinoma Drug: mDC3/8-KRAS Vaccine Phase 1

Detailed Description:

This is a single arm open label trial that will assess the safety and tolerability of mature dendritic cell (mDC3/8) vaccine (primer and booster) in subjects with resected pancreatic adenocarcinoma.

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 mutant KRAS peptides corresponding to the subject's specific tumor mutation and human leukocyte antigen type. 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 recurrence.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Mature Dendritic Cell Vaccination Against Mutated KRAS in Patients With Resectable Pancreatic Cancer
Actual Study Start Date : November 20, 2018
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: All subjects
All subjects will receive the vaccine and be followed per the schedule of procedures.
 Drug: mDC3/8-KRAS Vaccine
Mature dendritic cell (mDC3/8) vaccine (primer and booster) in subjects with resected pancreatic adenocarcinoma


Outcome Measures
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Primary Outcome Measures :
  1. Safety and side effects of vaccine per CTCAE 4.0 [ Time Frame: At time of consent through 30 days after the subject's last DC vaccine ]

Secondary Outcome Measures :
  1. Immune response measuring increased numbers of peptide specific T cells as calculated by the peptide-MHC multimer assay. [ Time Frame: Day 1 through week 12 ]
  2. Disease Free Survival [ Time Frame: 30 days following second vaccine through study completion approximately 12 months after the first DC vaccine ]

Eligibility Criteria
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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 KRAS(G12D-), KRAS(G12V-), KRAS(G12R-) or KRAS(G12C-mutated) pancreatic ductal adenocarcinoma who are at high risk of relapse and have no evidence of disease.
  • Expression of one or more of the following HLA class I alleles: HLA-A02, HLA-A03, HLA-A11, HLA-B07 and HLA-C08.
  • Male or female, age 18+
  • ECOG performance status 0-1
  • Certain required 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 treatment with more than two lines of cytotoxic chemotherapy. Radiotherapy is not considered a line of therapy.
  • Prior malignancy (except non-melanoma skin cancer) within 3 years.
  • Pregnant or nursing 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. Local (inhaled or topical) steroids or replacement dose prednisone (≤ 10 mg daily) are permitted.
  • Known chronic viral infections including hepatitis B, hepatitis C, and HIV.
  • Known allergy to eggs.
  • Prior history of uveitis or autoimmune inflammatory eye disease.
  • Uncontrolled intercurrent illness.
  • Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
Contacts and Locations
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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): NCT03592888


Contacts
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Contact: Gerald Linette, MD, PhD 215.573.7032 glinette@upenn.edu
Contact: Abramson Cancer Center 855.216.0098 PennCancerTrials@emergingmed.com

Locations
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United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Mark O'Hara, MD    215-360-0735    Mark.OHara@uphs.upenn.edu   
Contact: Abramson Cancer Center    855-216-0098    PennCancerTrials@emergingmed.com   
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Mark O'Hara, MD University of Pennsylvania
More Information
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03592888    
Other Study ID Numbers: UPCC 04218
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: April 6, 2023
Last Verified: April 2023

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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:
Pancreatic Adenocarcinoma
Cancer vaccine
Dendritic cell vaccine
Mutant KRAS
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms