Analyzing Childhood Recall Antigens in Patients With Pancreatic Cancer

NCT ID: NCT03848182

Last Updated: 2024-04-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-21
• Study Completion Date: 2019-11-11

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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Gemcitabine with TT vaccine booster

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

Group Type: EXPERIMENTAL

Gemcitabine

Intervention Type: DRUG

Gemcitabine will be administered on days 1, 8, 15 every 28 days

TT vaccine booster

Intervention Type: BIOLOGICAL

One human TT childhood vaccine booster will be administered on day 8

Interventions

Gemcitabine

Gemcitabine will be administered on days 1, 8, 15 every 28 days

Intervention Type: DRUG

TT vaccine booster

One human TT childhood vaccine booster will be administered on day 8

Intervention Type: BIOLOGICAL

Other Intervention Names

Gemzar; Tetanus vaccine

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pancreatic Cancer Action Network

OTHER

Sponsor Role: collaborator

Albert Einstein College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claudia Gravekamp, PhD

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine

Locations

Albert Einstein College of Medicine

The Bronx, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

422247

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2016-7197

Identifier Type: -

Identifier Source: org_study_id