A Study of Vaccination With Poly-ICLC and Dendritic Cells in Patients With Pancreatic Adenocarcinoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Medical University of South Carolina
Sponsor:
Information provided by (Responsible Party):
Steve H. Chin, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01677962
First received: August 17, 2012
Last updated: October 11, 2013
Last verified: October 2013
  Purpose

The main purpose of this study is to examine the safety of the study drug in patients with locally advanced unresectable pancreatic adenocarcinoma. The study team would like to know about any side effects a patient may have when given the study drug. Another goal of the study is to determine if combining dendritic cells and the study drug can be possibly used as a vaccine for this disease. Dendritic cells are cells that are present in the body's immune system that help your body fight disease.


Condition Intervention Phase
Pancreatic Adenocarcinoma Non-resectable
Poly ICLC
Dendritic Cells
Biological: Poly-ICLC
Biological: dendritic cell
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Feasibility and Safety Study of Vaccination With Poly-ICLC and Dendritic Cells in Patients With Locally Advanced Unresectable Pancreatic Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Primary Outcome [ Time Frame: from study consent to last treatment (Day 56) ] [ Designated as safety issue: Yes ]

    Number of Participants With Adverse Events (AEs)

    Evaluate the frequency of toxicities by type and severity, and dose of study drug according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.


  • Primary Objective [ Time Frame: from study consent to last treatment (Day 56) ] [ Designated as safety issue: Yes ]
    Determining the feasibility of generating dendritic cells and administering these cells as a vaccine to patients


Secondary Outcome Measures:
  • Secondary Outcome [ Time Frame: Average three months Per Participant ] [ Designated as safety issue: No ]
    Number of Participants With Tumor Response

  • Secondary Objective [ Time Frame: Post treatment ] [ Designated as safety issue: No ]
    Measure overall Survival


Estimated Enrollment: 12
Study Start Date: August 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dendritic cell and Poly-ICLC vaccination
Dendritic cell and Poly-ICLC vaccination will be administered directly into the tumor on Day 0 and Day 14 of Treatment Phase. Subjects will then have standard of care procedures along with injections of Poly-ICLC and dendritic cells for the remainder of the study.
Biological: Poly-ICLC Biological: dendritic cell

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Each of the following criteria must be met in order for a patient to be considered eligible for enrollment.

  • Patients must have histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma that is locally advanced and unresectable. Patients with endocrine or neuroendocrine tumors, lymphoma of the pancreas, or ampullary cancer are not eligible.
  • Patients must have measurable disease per RECIST 1.1. One or more tumors measurable on CT scan per RECIST 1.1. (Eisenhauer)
  • Patients may have had prior cancer therapy. Patients do not need to demonstrate progression to be considered for this trial.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
  • Age ≥ 18 years.
  • Patient must have an expected life expectancy greater than 3 months.
  • Signed, written IRB-approved informed consent.
  • Bilirubin ≤ 3 times upper limit of normal (CTCAE Grade 2 baseline)
  • AST (SGOT), ALT (SGPT) ≤ 3 x ULN (CTCAE Grade 1 baseline)
  • Serum creatinine ≤1.5 XULN (CTCAE Grade 1 baseline)
  • Acceptable hematologic status, defined as:
  • Absolute neutrophil count ≥ 1000 cells/mm3
  • Platelet count ≥ 75,000 (plt/mm3), (CTCAE Grade 1 baseline)
  • Hemoglobin ≥ 9 g/dL.
  • Urinalysis with no clinically significant abnormalities.
  • PT and PTT ≤ 1.5 X ULN after correction of nutritional deficiencies that may contribute to prolonged PT/PTT

Exclusion Criteria:

Each of the following criteria should not be present in order for the patient to be considered eligible for enrollment.

  • Patients must not have metastatic disease. Patients with evidence of metastatic disease at the time of screening or prior to the administration of DC vaccination will be considered a screen failure and excluded from study.
  • Prior surgery is allowed provided at least 14 days has elapsed between surgery and registration. Prior radiation/chemo is allowed provided that at least 28 days have elapsed since the last treatment.
  • Patients must not have any serious uncontrolled acute or chronic medical condition that would interfere with this treatment. Examples would include active acute or chronic infection requiring antibiotics, uncontrolled cardiovascular, endocrine, or infectious disease.
  • Patient must not have clinically significant ascites.
  • Patients must not have significant ongoing cardiac problems, myocardial infarction within the last six months, uncontrolled hypertension, unstable angina, uncontrolled arrhythmia or congestive heart failure.
  • Patients with known brain metastases are not eligible. However, brain-imaging studies are not required for eligibility if the patient has no neurologic signs or symptoms. If brainimaging studies are performed, they must be negative for disease. Patients must have no plans to receive concurrent chemotherapy, hormonal therapy, radiotherapy, immunotherapy or any other type of therapy for treatment of cancer while on this protocol treatment.
  • Due to the undetermined effect of this treatment regimen in patients with HIV-1 infection and the potential for serious interaction with anti-HIV medications, patients known to be infected with HIV are not eligible for this study.
  • Due to the possibility of harm to a fetus or nursing infant from this treatment regimen, patients must not be pregnant or nursing. Women of child bearing potential must have a negative pregnancy test completed during study screening. Women and men of reproductive potential must have agreed to use an effective contraceptive method.
  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01677962

Contacts
Contact: Steve Chin, M.D. 843792-1648 chin@musc.edu
Contact: Alan Brisendine 843-792-9007 brisend@musc.edu

Locations
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Steve Chin, MD    843-792-1648    chin@musc.edu   
Contact: Alan Brisendine    843-792-9007    brisend@musc.edu   
Principal Investigator: Steve Chin, MD         
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Steve Chin, MD Medical University of South Carolina
  More Information

No publications provided

Responsible Party: Steve H. Chin, Asst. Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01677962     History of Changes
Other Study ID Numbers: 101778
Study First Received: August 17, 2012
Last Updated: October 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Medical University of South Carolina:
locally advanced, unresectable pancreatic adenocarcinoma
Poly ICLC
dendritic cells

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Poly ICLC
Interferon Inducers
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 02, 2014