NCT03848182 · REGISTRY CONDITION SEARCH

Analyzing Childhood Recall Antigens in Patients With Pancreatic Cancer

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: TERMINATED
Registry last update: 2024-04-18

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Change in CD4 T Cell Responses Before TT Booster

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outcome · POSTED

Change in CD4 T Cell Responses Before TT Booster

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outcome · POSTED

Change in CD4 T Cell Responses After TT Booster

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outcome · POSTED

Change in CD4 T Cell Responses After TT Booster

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outcome · POSTED

Change in CD8 T Cell Responses Before TT Booster

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outcome · POSTED

Change in CD8 T Cell Responses Before TT Booster Vaccine

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outcome · POSTED

Change in CD8 T Cell Responses After TT Booster

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outcome · POSTED

Change in CD8 T Cell Responses After TT Booster

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outcome · POSTED

Change in Myeloid-derived Suppressor Cells

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility 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
healthy Volunteers: true
maximum Age: 100 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

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 Names
Drug: Gemcitabine
Biological: TT vaccine booster
label
Gemcitabine with TT vaccine booster
type
EXPERIMENTAL

interventions

arm Group Labels
Gemcitabine with TT vaccine booster
description
Gemcitabine will be administered on days 1, 8, 15 every 28 days
name
Gemcitabine
other Names
Gemzar
type
DRUG
arm Group Labels
Gemcitabine with TT vaccine booster
description
One human TT childhood vaccine booster will be administered on day 8
name
TT vaccine booster
other Names
Tetanus vaccine
type
BIOLOGICAL

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

SCREENING

Enrollment

count: 10
type: ACTUAL

Registered outcome plans (not posted results)

other Outcomes

measure
Change in Myeloid-derived Suppressor Cells
time Frame
Day 8

primary Outcomes

description
The relative difference in CD4 T cell counts before and after administration of the TT booster vaccine (Day 8) will be compared. The number of cells per microliter (cells/µL) will be determined. The proportion of at least 3-fold increase will be reported along with its 95% CI. The actual magnitude of change will be examined by taking a log scale of CD4 counts and report a mean of change on CD4 on its log scale along with its 95% CI.
measure
Change in CD4 T Cell Responses Before TT Booster
time Frame
Day 1
description
The relative difference in CD4 T cell counts before and after administration of the TT booster vaccine (Day 8) will be compared. The number of cells per microliter (cells/µL) will be determined. The proportion of at least 3-fold increase will be reported along with its 95% CI. The actual magnitude of change will be examined by taking a log scale of CD4 counts and report a mean of change on CD4 on its log scale along with its 95% CI.
measure
Change in CD4 T Cell Responses Before TT Booster
time Frame
Day 8
description
The relative difference in CD4 T cell counts before and after administration of the TT booster vaccine (Day 8) will be compared. The number of cells per microliter (cells/µL) will be determined. The proportion of at least 3-fold increase will be reported along with its 95% CI. The actual magnitude of change will be examined by taking a log scale of CD4 counts and report a mean of change on CD4 on its log scale along with its 95% CI.
measure
Change in CD4 T Cell Responses After TT Booster
time Frame
Day 15
description
The relative difference in CD4 T cell counts before and after administration of the TT booster vaccine (Day 8) will be compared. The number of cells per microliter (cells/µL) will be determined. The proportion of at least 3-fold increase will be reported along with its 95% CI. The actual magnitude of change will be examined by taking a log scale of CD4 counts and report a mean of change on CD4 on its log scale along with its 95% CI.
measure
Change in CD4 T Cell Responses After TT Booster
time Frame
Day 28

secondary Outcomes

description
The relative difference in CD8 T cell counts before and after administration of the TT booster vaccine (Day 8) will be compared. The number of cells per microliter (cells/µL) will be determined. The proportion of at least 3-fold increase will be reported along with its 95% CI. The actual magnitude of change will be examined by taking a log scale of CD8 counts and report a mean of change on CD8 on its log scale along with its 95% CI.
measure
Change in CD8 T Cell Responses Before TT Booster
time Frame
Day 1
description
The relative difference in CD8 T cell counts before and after administration of the TT booster vaccine (Day 8) will be compared. The number of cells per microliter (cells/µL) will be determined. The proportion of at least 3-fold increase will be reported along with its 95% CI. The actual magnitude of change will be examined by taking a log scale of CD8 counts and report a mean of change on CD8 on its log scale along with its 95% CI.
measure
Change in CD8 T Cell Responses Before TT Booster Vaccine
time Frame
Day 8
description
The relative difference in CD8 T cell counts before and after administration of the TT booster vaccine (Day 8) will be compared. The number of cells per microliter (cells/µL) will be determined. The proportion of at least 3-fold increase will be reported along with its 95% CI. The actual magnitude of change will be examined by taking a log scale of CD8 counts and report a mean of change on CD8 on its log scale along with its 95% CI.
measure
Change in CD8 T Cell Responses After TT Booster
time Frame
Day 15
description
The relative difference in CD8 T cell counts before and after administration of the TT booster vaccine (Day 8) will be compared. The number of cells per microliter (cells/µL) will be determined. The proportion of at least 3-fold increase will be reported along with its 95% CI. The actual magnitude of change will be examined by taking a log scale of CD8 counts and report a mean of change on CD8 on its log scale along with its 95% CI.
measure
Change in CD8 T Cell Responses After TT Booster
time Frame
Day 28

Full 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.
detailed Description: Treating PDAC patients with gemcitabine and one TT booster Gemcitabine will be delivered as is standard of care. However, doses may be modified by the treating physician based on patient tolerance. Patients diagnosed with PDAC will be treated with Gemcitabine and boosted once with the human childhood vaccine to TT by Dr. Chuy as outlined in Fig 2. Gemcitabine will be administered on days 1, 8, 15 every 28 days, and one booster with the human TT childhood vaccine will be administered on day 8 (there must be 2 hrs between the TT booster and the Gemcitabine treatment). Blood will be drawn just before each Gemcitabine treatment, except on day 8 at least 2 hrs will be needed between the blood draw and Gemcitabine treatment because the TT booster needs to be given just after the blood draw but 2 hrs before the Gemcitabine treatment (Fig 2). Three tubes of 10 mls each with heparinized blood will be needed for the isolation of peripheral blood mononuclear cells (PBMC). Two tubes will be used to analyze the T cells and one tube for analyzing the MDSC. The memory T cells and MDSC will be analyzed in the laboratory of Dr. Gravekamp.

Source references

Source notices and limitations

Discovery and provenance

release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-54590961e189f849a401
requested nct id
NCT03848182
primary nct id
NCT03848182
source kind
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source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Childhood+Pancreatic+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
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nct id
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occurrences
context exact
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end
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exact text
NCT03848182
start
0
offset unit
unicode_code_points
query cond
Childhood Pancreatic Cancer
query disease state id
ds-pancreatic-cancer-pediatric
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-childhood-pancreatic-cancer-000.json
source file sha256
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source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Childhood+Pancreatic+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice