A Feasibility and Safety Study of Vaccination With Poly-ICLC and Peptide-pulsed Dendritic Cells in Patients With Metastatic, Locally Advanced, Unresectable, or Recurrent Pancreatic Adenocarcinoma

Patient must not have clinically significant ascites.

Patients must be HLA-A2 positivity by serological testing.

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.

One or more tumors measurable on CT scan per RECIST 1.1. (Eisenhauer)

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.

A negative pregnancy test (if female).

Acceptable organ function:

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:

Absolute neutrophil count \> 1000 cells/mm3,

Platelet count \> 75,000 (plt/mm3), (CTCAE Grade 1 baseline)

Hemoglobin \> 9 g/dL.

Urinalysis: No clinically significant abnormalities.

PT and PTT \< 1.5 X ULN after correction of nutritional deficiencies that may contribute to prolonged PT/PTT.

No evidence of clinically significant, uncontrolled cardiovascular, endocrine, or infectious disease.

Patients must not have any serious uncontrolled acute or chronic medical condition that would interfere with this treatment. An example would be an active acute or chronic infection requiring antibiotics

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 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 possibility of harm to a fetus or nursing infant from this treatment regimen, patients must not be pregnant or nursing. 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.

What this study is about