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A Feasibility and Safety Study of Vaccination With Poly-ICLC and Dendritic Cells in HLA-A2 Negative Patients With Locally Advanced Unresectable Pancreatic Adenocarcinoma

Phase 0
18 Years
Open (Enrolling)
Pancreatic Adenocarcinoma Non-resectable, HLA A2 Negative, Poly ICLC, Dendritic Cells

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Trial Information

A Feasibility and Safety Study of Vaccination With Poly-ICLC and Dendritic Cells in HLA-A2 Negative Patients With Locally Advanced Unresectable Pancreatic Adenocarcinoma

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

- Patients must complete an HLA-A2 evaluation by serological testing and must be HLA-A2

- 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 who are identified as HLA-A2 positive will be excluded.

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Primary Outcome

Outcome Description:

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.

Outcome Time Frame:

from study consent to last treatment (Day 56)

Safety Issue:


Principal Investigator

Steve Chin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical University of South Carolina


United States: Food and Drug Administration

Study ID:




Start Date:

August 2012

Completion Date:

August 2014

Related Keywords:

  • Pancreatic Adenocarcinoma Non-resectable
  • HLA A2 Negative
  • Poly ICLC
  • Dendritic Cells
  • locally advanced, unresectable pancreatic adenocarcinoma
  • HLA A2 negative
  • Poly ICLC
  • dendritic cells
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous



Medical University of South CarolinaCharleston, South Carolina  29425-0721