Vaccine Therapy in Treating Patients With Pancreatic Cancer That Has Been Removed by Surgery

OBJECTIVES:

Primary

- Determine the safety of primary and boost vaccinations with lethally irradiated
allogeneic pancreatic tumor cells transfected with sargramostim (GM-CSF) gene vaccine in
patients with surgically resected adenocarcinoma of the head, neck, or uncinate of the
pancreas.

Secondary

- Correlate specific in vivo parameters of immune response (e.g., mesothelin, prostate
stem cell antigen, and mutated k-ras-specific T-cell responses) with clinical response
in patients treated with this regimen.

- Determine the efficacy, in terms of overall and recurrence-free survival, of this
regimen in these patients.

- Correlate serum GM-CSF levels with longevity of an allogeneic vaccine after semi-annual
boosting in these patients.

- Determine the psychosocial (e.g., demographics, quality of life, hope, trust, social
support, decision control, and advanced directives) and symptom (e.g., pain, anorexia,
fatigue, and mood state) profiles in these patients and explore changes over time.

OUTLINE: This is a open-label study. Patients are stratified according to prior vaccination
with allogeneic sargramostim (GM-CSF)-secreting pancreatic tumor cell vaccine (yes [stratum
I] vs no [stratum II]).

- Stratum I: Patients receive booster vaccination comprising allogeneic GM-CSF plasmid DNA
pancreatic tumor cell vaccine subcutaneously (SC). Treatment repeats every 6 months in
the absence of disease progression or unacceptable toxicity.

- Stratum II: Patients receive priming vaccinations SC once a month for 3 months and then
receive booster vaccinations as in stratum I.

Patients complete self-reported psychosocial (including quality of life, hope, and trust) and
symptom (including pain, fatigue, anorexia, and mood) questionnaires at day 0 and day 28.

After completion of study treatment, patients are followed at day 28 and then annually for 15
years.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

- Confirmed diagnosis of adenocarcinoma of the head, neck, tail, or uncinate of the
pancreas meeting the following criteria:

- Stage I-III disease

- Prior surgical resection required

- No radiographic evidence of disease recurrence

PATIENT CHARACTERISTICS:

- ECOG performance status 0-1

- Hemoglobin ≥ 9 g/dL

- Absolute neutrophil count ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Creatinine ≤ 2.0 mg/dL

- Bilirubin ≤ 2.0 mg/dL (unless due to known Gilbert's syndrome)

- AST, ALT, and amylase ≤ 2 times upper limit of normal (ULN)

- Alkaline phosphatase ≤ 5 times ULN

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other uncontrolled illness

- No active, ongoing infection

- No history of autoimmune disease (e.g., systemic lupus erythematosus, sarcoidosis,
rheumatoid arthritis, glomerulonephritis, or vasculitis)

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- At least 28 days since prior anticancer therapy (e.g., adjuvant chemoradiotherapy)

- At least 28 days since prior systemic steroid therapy

- At least 6 months since last vaccination with sargramostim (GM-CSF) plasmid DNA
pancreatic tumor cell vaccine (cell lines Panc 10.05 and Panc 6.03) while enrolled on
SKCCC-J9617 or SKCCC-J9988

- No concurrent systemic steroid therapy during and for ≥ 28 days after vaccination

- No concurrent radiation therapy

- No other concurrent immunotherapy, biologic therapy, or gene therapy