Back to resultsAnalyzing Childhood Recall Antigens in Patients With Pancreatic Cancer
Primary Purpose
Pancreatic Cancer
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gemcitabine
TT vaccine booster
Sponsored by
About this trial
This is an interventional screening trial for Pancreatic Cancer focused on measuring T-cell responses, Pancreatic cancer, Gemcitabine, Perforin, Granzyme-B, Myeloid-derived suppressor cells
Eligibility Criteria
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
Sites / Locations
- Albert Einstein College of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gemcitabine with TT vaccine booster
Arm Description
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
Outcomes
Primary Outcome Measures
Change in CD4 T cell responses before TT booster vaccine
Blood will be drawn
Change in CD4 T cell responses after TT booster vaccine
Blood will be drawn
Secondary Outcome Measures
Change in CD8 T cell responses before TT booster vaccine
Blood will be drawn
Change in CD8 T cell responses after TT booster vaccine
Blood will be drawn
Full Information
NCT ID
NCT03848182
First Posted
February 19, 2019
Last Updated
November 12, 2019
Sponsor
Albert Einstein College of Medicine
Collaborators
Pancreatic Cancer Action Network
1. Study Identification
Unique Protocol Identification Number
NCT03848182
Brief Title
Analyzing Childhood Recall Antigens in Patients With Pancreatic Cancer
Official Title
Analysis of T Cells to Tetanus Toxoid Antigens in Patients With Pancreatic Cancer Treated With Gemcitabine
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual
Study Start Date
July 21, 2017 (Actual)
Primary Completion Date
November 11, 2019 (Actual)
Study Completion Date
November 11, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albert Einstein College of Medicine
Collaborators
Pancreatic Cancer Action Network
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
T-cell responses, Pancreatic cancer, Gemcitabine, Perforin, Granzyme-B, Myeloid-derived suppressor cells
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gemcitabine with TT vaccine booster
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Gemcitabine will be administered on days 1, 8, 15 every 28 days
Intervention Type
Biological
Intervention Name(s)
TT vaccine booster
Intervention Description
One human TT childhood vaccine booster will be administered on day 8
Primary Outcome Measure Information:
Title
Change in CD4 T cell responses before TT booster vaccine
Description
Blood will be drawn
Time Frame
Day 8
Title
Change in CD4 T cell responses after TT booster vaccine
Description
Blood will be drawn
Time Frame
Day 8
Secondary Outcome Measure Information:
Title
Change in CD8 T cell responses before TT booster vaccine
Description
Blood will be drawn
Time Frame
Day 8
Title
Change in CD8 T cell responses after TT booster vaccine
Description
Blood will be drawn
Time Frame
Day 8
Other Pre-specified Outcome Measures:
Title
Change in myeloid-derived suppressor cells
Description
Blood will be drawn
Time Frame
Day 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia Gravekamp, PhD
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Analyzing Childhood Recall Antigens in Patients With Pancreatic Cancer
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