Analyzing Childhood Recall Antigens in Patients With Pancreatic Cancer

NCT03848182 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: 2016-7197422247
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

T-cell responses; Pancreatic cancer; Gemcitabine; Perforin; Granzyme-B; Myeloid-derived suppressor cells

Outcome Measures

Primary Outcomes (4)

• Change in CD4 T Cell Responses Before TT Booster

  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.

  Day 1

• Change in CD4 T Cell Responses Before TT Booster

  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.

  Day 8

• Change in CD4 T Cell Responses After TT Booster

  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.

  Day 15

• Change in CD4 T Cell Responses After TT Booster

  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.

  Day 28

Secondary Outcomes (4)

• Change in CD8 T Cell Responses Before TT Booster

  Day 1

• Change in CD8 T Cell Responses Before TT Booster Vaccine

  Day 8

• Change in CD8 T Cell Responses After TT Booster

  Day 15

• Change in CD8 T Cell Responses After TT Booster

  Day 28

Other Outcomes (1)

• Change in Myeloid-derived Suppressor Cells

  Day 8

Study Arms (1)

Gemcitabine with TT vaccine booster

EXPERIMENTAL

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

Drug: Gemcitabine; Biological: TT vaccine booster

Interventions

Gemcitabine DRUG

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

Also known as: Gemzar

Gemcitabine with TT vaccine booster

TT vaccine booster BIOLOGICAL

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

Also known as: Tetanus vaccine

Gemcitabine with TT vaccine booster

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• Pancreatic Cancer Action Network: collaborator

Study Sites (1)

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Lipodystrophy, Congenital Generalized

Interventions

Gemcitabine; Tetanus Toxoid

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lipodystrophy; Skin Diseases, Metabolic; Skin Diseases; Skin and Connective Tissue Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Toxoids; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Dr. Jennifer Chuy, Co-Investigator, Assistant Professor (Oncology)
• Organization: Montefiore Medical Center; 1695 Eastchester Road

jchuy@montefiore.org

718-405-8505

Study Officials

• Claudia Gravekamp, PhD

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: February 20, 2019
• Study Start: July 21, 2017
• Primary Completion: November 23, 2018
• Study Completion: November 11, 2019
• Last Updated: April 18, 2024
• Results First Posted: April 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)