Vaccine Therapy Combined With Adjuvant Chemoradiotherapy in Treating Patients With Resected Stage I or Stage II Adenocarcinoma (Cancer) of the Pancreas

• Estimate overall survival and disease-free survival in patients treated with adjuvant chemoradiotherapy in sequence with the irradiated allogeneic GM-CSF transfected pancreatic tumor cell lines versus chemoradiotherapy alone. [ Time Frame: Continuous ] [ Designated as safety issue: No ]
  

• To further identify and characterize toxicities associated with intradermal injections of the vaccine that were initially reported in the phase 1 trial. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  
• Estimate the association of specific in vivo parameters of immune response with clinical responses in patients treated with combination chemoradiotherapy together with the irradiated allogeneic GM-CSF transfected pancreatic tumor cell lines. [ Time Frame: Continuous ] [ Designated as safety issue: No ]
  The specific immune parameters include: post-vaccination delayed type hypersensitivity reactions to autologous tumor and the degree of local eosinophil, macrophage, and T cell infiltration at the vaccine site, and mesothelin-specific T cell responses.
  
  

Biological: GVAX pancreatic cancer vaccine
Patients will receive vaccinations consisting of 5E8 vaccine cells. The first vaccination is administered 6-8 weeks after surgery. Four to eight weeks following the completion of the last cycle of adjuvant radiation and chemotherapy eligible patients will receive three additional vaccinations at one month intervals. Patients who continue to remain disease-free will receive a fifth "booster" vaccination, six months following the fourth vaccination.
Procedure: Adjuvant therapy (5-FU and radiation)
4 weeks after vaccination patients will start a 26-28 week course of adjuvant therapy consisting of combined chemotherapy and local radiation. 5-FU based chemotherapy and radiation therapy as adjuvant treatment following surgical resection of pancreatic adenocarcinoma is the accepted standard of care as described by a number of pancreas cancer groups including the RTOG, the American College of Surgeons Oncology Group (ACOSOG) and the National Comprehensive Cancer Network (NCCN) pancreatic adenocarcinoma practice guideline expert panel.

OBJECTIVES:

Primary

• Determine overall and disease-free survival of patients with resected stage I or II adenocarcinoma of the pancreas treated with adjuvant chemoradiotherapy in combination with GVAX pancreatic cancer vaccine.

Secondary

• Correlate specific in vivo parameters of immune response (post-vaccination delayed-type hypersensitivity reactions to autologous tumor, mesothelin-specific T-cell response, and the degree of local eosinophil, macrophage, and T-cell infiltration at the vaccine site) with clinical responses in patients treated with this regimen.
• Determine the toxic effects associated with intradermal injections of this vaccine in these patients.

OUTLINE: This is an open-label study.

• Post surgery vaccination: Within 8-10 weeks after pancreaticoduodenectomy, patients receive GVAX pancreatic cancer vaccine intradermally (ID) on day 0.
• Adjuvant chemoradiotherapy: Within 16-28 days after the first vaccination, patients receive fluorouracil (5-FU) IV continuously for 3 weeks. Approximately 1-2 weeks after completion of 5-FU, patients receive chemoradiotherapy comprising radiotherapy daily and 5-FU IV continuously for 26-28 weeks. Approximately 3-5 weeks after completion of chemoradiotherapy, patients receive 5-FU IV continuously for 4 weeks. 5-FU repeats every 6 weeks for 2 courses.
• Post chemoradiotherapy vaccination: Within 4-8 weeks after the completion of chemoradiotherapy, patients receive GVAX pancreatic cancer vaccine ID on days 0, 28, 56, and 196.

Treatment continues in the absence of unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.