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Analyzing Childhood Recall Antigens in Patients With Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT03848182
Recruitment Status : Recruiting
First Posted : February 20, 2019
Last Update Posted : February 20, 2019
Sponsor:
Collaborator:
Pancreatic Cancer Action Network
Information provided by (Responsible Party):
Claudia Gravekamp, Albert Einstein College of Medicine

Tracking Information
First Submitted Date  ICMJE February 19, 2019
First Posted Date  ICMJE February 20, 2019
Last Update Posted Date February 20, 2019
Actual Study Start Date  ICMJE July 21, 2017
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2019)
  • Change in CD4 T cell responses before TT booster vaccine [ Time Frame: Day 8 ]
    Blood will be drawn
  • Change in CD4 T cell responses after TT booster vaccine [ Time Frame: Day 8 ]
    Blood will be drawn
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2019)
  • Change in CD8 T cell responses before TT booster vaccine [ Time Frame: Day 8 ]
    Blood will be drawn
  • Change in CD8 T cell responses after TT booster vaccine [ Time Frame: Day 8 ]
    Blood will be drawn
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 19, 2019)
Change in myeloid-derived suppressor cells [ Time Frame: Day 8 ]
Blood will be drawn
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Analyzing Childhood Recall Antigens in Patients With Pancreatic Cancer
Official Title  ICMJE Analysis of T Cells to Tetanus Toxoid Antigens in Patients With Pancreatic Cancer Treated With Gemcitabine
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE
  • Drug: Gemcitabine
    Gemcitabine will be administered on days 1, 8, 15 every 28 days
  • Biological: TT vaccine booster
    One human TT childhood vaccine booster will be administered on day 8
Study Arms  ICMJE Experimental: 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
Interventions:
  • Drug: Gemcitabine
  • Biological: TT vaccine booster
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 19, 2019)
25
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2019
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03848182
Other Study ID Numbers  ICMJE 2016-7197
422247 ( Other Grant/Funding Number: Pancreatic Cancer Action Network )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Claudia Gravekamp, Albert Einstein College of Medicine
Study Sponsor  ICMJE Albert Einstein College of Medicine
Collaborators  ICMJE Pancreatic Cancer Action Network
Investigators  ICMJE
Principal Investigator: Claudia Gravekamp, PhD Albert Einstein College of Medicine
PRS Account Albert Einstein College of Medicine
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP