A Phase III Study of Chemotherapy and Chemoradiotherapy with or without HyperAcute®-Pancreas (Algenpantucel-L) Immunotherapy in Subjects with Surgically Resected Pancreatic Cancer

This randomized phase III trial studies the overall survival of patients with surgically resected pancreatic cancer treated afterward with gemcitabine alone or with 5-FU chemoradiation with or without HyperAcute®-Pancreas, or algenpantucel-L immunotherapy.

Eligibility criteria

• 18 years or older with a histological diagnosis of adenocarcinoma of the pancreas confirmed by pathology.
• American Joint Committee on Cancer (AJCC) Stage I or II Pancreatic carcinoma. Patients must have undergone surgical resection for the tumor, and extent of resection must be either R0 (complete resection with grossly and microscopically negative margins of resection) or R1 (grossly negative but positive microscopically margins of resection).
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
• Serum albumin ≥2.0 gm/dL.
• Expected survival ≥6 months.
• Subjects must be able to take in adequate daily calorie intake based on judgment of clinical investigator.
• Adequate organ function including:
  A. Marrow: white blood cells ≥3000/mm3 and platelets ≥100,000/mm3.
  B. Hepatic: serum total bilirubin ≤2 x ULN mg/dL, ALT (SGPT) and AST (SGOT) ≤3 x upper limit of normal (ULN).
  C. Renal: serum creatinine (sCr) ≤2.0 x ULN, or creatinine clearance (Ccr) ≥30 mL/min.

Steven Williamson, MD - Principal Investigator