A Phase III Study of Chemotherapy and Chemoradiotherapy With or Without Algenpantucel-L (HyperAcuteŽ-Pancreas) Immunotherapy in Subjects With Surgically Resected Pancreatic Cancer
The purpose of this study is to assess overall survival after treatment with a regimen of adjuvant therapy (Gemcitabine alone or with 5-FU chemoradiation) with or without HyperAcuteŽ-Pancreas (algenpantucel-L) immunotherapy in subjects who have undergone surgical resection.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- biological : HyperAcute-Pancreas Immunotherapy
- drug : Gemcitabine
- radiation : 5FU Chemoradiation
Phase: Phase 3
Ages Eligible For Study:
- 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 (WBC) ?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. - First vaccination must be within 10 weeks after surgery. - Patients 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. Patients may not be consented by a durable power of attorney (DPA). - All subjects of child producing potential must agree to use contraception or avoidance of pregnancy measures while enrolled on study and receiving the experimental product, and for one month after the last immunization.