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Analyzing Childhood Recall Antigens in Patients With Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT03848182
Recruitment Status : Recruiting
First Posted : February 20, 2019
Last Update Posted : February 20, 2019
Sponsor:
Collaborator:
Pancreatic Cancer Action Network
Information provided by (Responsible Party):
Claudia Gravekamp, Albert Einstein College of Medicine

Brief Summary:
The investigator is developing an immune therapy against pancreatic cancer. Immune cells, known as "T cells with tumor killing capacity", are involved in this immune therapy. In mice with pancreatic cance there is evidence that one tetanus toxoid (TT) vaccination (that patients receive from childhood) combined with Gemcitabine activates these killer T cells. (Gemcitabine improves T cell responses) These killer T cells are able to destroy tumor cells uploaded with TT protein (such studies are planned in future clinical trials). The goal of this study is to test whether one TT vaccination combined with Gemcitabine treatment activates the same T cells in pancreatic cancer patients.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Gemcitabine Biological: TT vaccine booster Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Analysis of T Cells to Tetanus Toxoid Antigens in Patients With Pancreatic Cancer Treated With Gemcitabine
Actual Study Start Date : July 21, 2017
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019


Arm Intervention/treatment
Experimental: Gemcitabine with TT vaccine booster
Gemcitabine will be delivered as is standard of care. Patients diagnosed with pancreatic ductal carcinoma (PCD) will be treated with Gemcitabine and boosted once with the human childhood vaccine to TT
Drug: Gemcitabine
Gemcitabine will be administered on days 1, 8, 15 every 28 days

Biological: TT vaccine booster
One human TT childhood vaccine booster will be administered on day 8




Primary Outcome Measures :
  1. Change in CD4 T cell responses before TT booster vaccine [ Time Frame: Day 8 ]
    Blood will be drawn

  2. Change in CD4 T cell responses after TT booster vaccine [ Time Frame: Day 8 ]
    Blood will be drawn


Secondary Outcome Measures :
  1. Change in CD8 T cell responses before TT booster vaccine [ Time Frame: Day 8 ]
    Blood will be drawn

  2. Change in CD8 T cell responses after TT booster vaccine [ Time Frame: Day 8 ]
    Blood will be drawn


Other Outcome Measures:
  1. Change in myeloid-derived suppressor cells [ Time Frame: Day 8 ]
    Blood will be drawn



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Histologically or cytologically confirmed adenocarcinoma of the pancreas
  2. Patients is a candidate for gemcitabine chemotherapy (adjuvant, metastatic, locally advanced, borderline resectable settings all permitted)
  3. Patients at least 18 years of age
  4. ECOG performance status 0-2
  5. Consent to donate 12 tubes of peripheral blood of 10 mL each
  6. Adequate organ function as defined as -neutrophil count ≥ 1200 -platelets ≥ 75,000 -hemoglobin ≥ 8.0 -bilirubin ≤ 2.0 -creatinine ≤2.0 or calculated GFR ≥ 30
  7. Ability to understand and willingness to sign a written informed consent document
  8. Prior chemotherapy permitted, as long as 60 days have lapsed since last dose. Prior radiation therapy permitted, as long as 28 days lapsed since last treatment.
  9. Patients may receive other concurrent chemotherapy, immunotherapy, or radiotherapy

Exclusion Criteria:

  1. Patients never been immunized with tetanus toxoid (TT). Patients with a history of adverse reaction to tetanus vaccine (with the exception of self-limited fever or local tissue reaction
  2. Patients may not be receiving any investigational agents
  3. Pregnant women
  4. Patients with HIV

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): NCT03848182


Locations
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United States, New York
Albert Einstein College of Medicine Recruiting
Bronx, New York, United States, 10461
Contact: Claudia Gravekamp, PhD    718-430-4048    claudia.gravekamp@einstein.yu.edu   
Contact: Jennifer Chuy, MD    718-405-8404    jchuy@montefiore.org   
Sub-Investigator: Jennifer Chuy, MD         
Sponsors and Collaborators
Albert Einstein College of Medicine
Pancreatic Cancer Action Network
Investigators
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Principal Investigator: Claudia Gravekamp, PhD Albert Einstein College of Medicine

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Responsible Party: Claudia Gravekamp, Principal Investigator, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT03848182     History of Changes
Other Study ID Numbers: 2016-7197
422247 ( Other Grant/Funding Number: Pancreatic Cancer Action Network )
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Claudia Gravekamp, Albert Einstein College of Medicine:
T-cell responses
Pancreatic cancer
Gemcitabine
Perforin
Granzyme-B
Myeloid-derived suppressor cells
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Vaccines
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents