Dendritic Cell Vaccine and Chemotherapy for Patients With Pancreatic Cancer

This is a single center, exploratory pilot safety, open label, phase I trial that will
evaluate the combination of DC vaccination in 2 groups of patients when combined with
chemotherapy including FOLFIRINOX and gemcitabine+nab-paclitaxel in patients with pancreatic
cancer. The investigations will accrue 20 evaluable subjects over 20 months with 10 patients
in each group. Subjects will be assigned to group 1 or group 2 according to the subject's
disease stage.

The protocol will be conducted in two stages:

The 1st 3 patients will be enrolled to either group to receive DC vaccinations combined with
standard chemotherapy. A safety analysis will be performed after the first 3 patients have
completed 6 vaccines. If no vaccine dose-limiting toxicity occurs in any of the 3 patients
then the study will proceed with stage 2. Stage 2 will include the enrollment of the
remaining 17 patients.

Inclusion Criteria:

- Suspected pancreatic ductal adenocarcinoma (PDAC) prior to diagnosis or histological
diagnosis of adenocarcinoma of the pancreas confirmed by pathology.

- Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2.

- Serum Albumin greater than or equal to 2.0 gm/dL

- Expected survival greater than or equal to 6 months.

- Adequate hematologic function as defined by

- Absolute Neutrophil Count (ANC) greater than 1500/mm^3

- Platelets greater than or equal to 70,000/mm^3

- Hemoglobin greater than 9 g/dL

- Adequate liver function, as defined by:

- Serum Total Bilirubin less than or equal to 2 x Upper limit of normal (ULN) mg/dL

- Alanine transaminase (ALT) and Aspartate transaminase (AST) less than or equal to 2.5x
Upper limit of normal (ULN)

- Serum Creatinine less than or equal to 2 x Upper limit of normal (ULN) or creatinine
clearance greater than or equal to 30 ml/min

- All females of child bearing potential must agree to use contraception to avoid
pregnancy throughout the study and for 1 month after the last DC vaccination.

- Subjects must have the ability to understand the study, its inherent risks, side
effects and potential benefits and be able to give written informed consent to
participate. Subjects may not be consented by a medical power of attorney.

- Subject must be accessible for treatment and follow up.

Exclusion Criteria:

- History of Organ transplant

- Other malignancy within 5 years, unless the probability of recurrence of the prior
malignancy is <5% as determined by the principal investigator.

- Current, active immunosuppressive therapy such as cyclosporine, tacrolimus

- Subjects taking chronic systemic corticosteroid therapy for any reason are not
eligible. Subjects may receive steroids as prophylactic anti-emetics, not toe exceed
10mg Decadron weekly. Subjects receiving inhaled or topical corticosteroids are
eligible. Subjects who require chronic systemic corticosteroids after beginning
vaccination will be removed from the study.

- Significant or uncontrolled congestive heart failure, myocardial infarction or
significant ventricular arrhythmias within the last 6 months

- Active infection or antibiotics within 48 hours prior to study enrollment, including
unexplained fever

- Autoimmune disease ( e.g. systemic lupus erythematosis, rheumatoid arthritis).
Subjects with remote history of asthma or mild active asthma are eligible.

- Other severe and/or uncontrolled medical conditions or other conditions that could
affect their participation such as:

- Severe impaired lung functions as defined by spirometry and diffusing capacity of lung
for carbon monoxide (DLCO) that is 50% of the normal predicted value and/or O2
saturation that is 88% or less at rest on room air

- Uncontrolled diabetes as defined by fasting serum glucose >250 mg/dL

- Live disease such as cirrhosis or severe hepatic impairment (child pugh class C)

- Presence of a condition or abnormality that in the opinion of the investigator would
compromise the safety of the patient or quality of the data.

- Other investigational or anti-cancer treatments while participating in this study.

- Other active cancer

- Women who are pregnant or breastfeeding

- Known to be HIV positive