Analyzing Childhood Recall Antigens in Patients With Pancreatic Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Analysis of T Cells to Tetanus Toxoid Antigens in Patients With Pancreatic Cancer Treated With Gemcitabine

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: Gemcitabine
* Biological: TT vaccine booster


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically confirmed adenocarcinoma of the pancreas Patients is a candidate for gemcitabine chemotherapy (adjuvant, metastatic, locally advanced, borderline resectable settings all permitted) Patients at least 18 years of age ECOG performance status 0-2 Consent to donate 12 tubes of peripheral blood of 10 mL each 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 Ability to understand and willingness to sign a written informed consent document 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. Patients may receive other concurrent chemotherapy, immunotherapy, or radiotherapy Exclusion Criteria: 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 Patients may not be receiving any investigational agents Pregnant women Patients with HIV

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gemcitabine with TT vaccine booster<br>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<br>* Gemcitabine will be administered on days 1, 8, 15 every 28 days<br>Biological: TT vaccine booster<br>* One human TT childhood vaccine booster will be administered on day 8<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in CD4 T cell responses before TT booster vaccine | Blood will be drawn | Day 8 | 
| Change in CD4 T cell responses after TT booster vaccine | Blood will be drawn | Day 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in CD8 T cell responses before TT booster vaccine | Blood will be drawn | Day 8 | 
| Change in CD8 T cell responses after TT booster vaccine | Blood will be drawn | Day 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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T-cell responses, Pancreatic cancer, Gemcitabine, Perforin, Granzyme-B, Myeloid-derived suppressor cells