Analyzing Childhood Recall Antigens in Patients With Pancreatic Cancer

• Status: Terminated
• Trial end date: 2019-11-11
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Albert Einstein College of Medicine
• Collaborators: Pancreatic Cancer Action Network; Pancreatic Cancer Action Network (PCAN)
• Treatments: Gemcitabine; Vaccines

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