Analyzing Childhood Recall Antigens in Patients With Pancreatic Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Cancer, Pancreatic Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 2/22/2019 |
| Start Date: | July 21, 2017 |
| End Date: | June 30, 2019 |
Analysis of T Cells to Tetanus Toxoid Antigens in Patients With Pancreatic Cancer Treated With Gemcitabine
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.
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.
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
We found this trial at
1
site
1300 Morris Park Ave
Bronx, New York 10461
Bronx, New York 10461
(718) 430-2000
Phone: 718-430-4048
Albert Einstein College of Medicine The Albert Einstein College of Medicine of Yeshiva University is...
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