A Phase III Study of Chemotherapy and Chemoradiotherapy With or Without HyperAcute®-Pancreas Immunotherapy in Subjects with Surgically Resected Pancreatic Cancer
This trial is an open-label, randomized, multi-institutional efficacy study. In this Phase III trial, patients with pancreatic cancer who have undergone surgical resection with minimal residual disease will be randomized (1:1) to receive standard of care adjuvant therapy plus or minus HyperAcute(TM)-Pancreatic Cancer Vaccine. The primary endpoint of the study is overall survival.Endpoints of the study include overall survival, disease-free survival, safety/toxicity, and immune responses. We plan to enroll 20 subjects onto this study at UT Southwestern Medical Center. The projected enrollment will be 722 subjects (361 SOC + vaccine; 361 SOC alone) in this research study throughout the United States.
Subjects randomized to the vaccine group will receive up to a total of 18 vaccinations with the HyperAcute(TM) vaccine cells given prior to and during chemotherapy and chemoradiation. All subjects (SOC + vaccine and SOC alone) will be followed during treatment, every 6 months for 36 months, then every 6 months for 2 years, then annually thereafter for a lifetime. Subjects will continue to be followed even if enrollment of subjects stops early due to success or lack of effectiveness or success.
1. A histological diagnosis of adenocarcinoma of the pancreas confirmed by pathology. Mixed subtypes of adenocarcinoma are acceptable as long as majority of cells are ductal adenocarcinoma.
2. AJCC Stage I or II Pancreatic carcinoma (See Appendix A). 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).
3. Eastern Cooperative Oncology Group (ECOG) Performance Status < 2. Appendix B
4. Serum albumin > 2.0 gm/dL.
5. Expected survival > 6 months.
6. Subjects must be able to take in adequate daily calorie intake based on judgment of clinical investigator.
7. Adequate organ function including:
A. Marrow: 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.
8. First vaccination must be within 8 weeks after surgery.
9. 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).
10. 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.
11. Male and Female patients of all ethnic and racial groups.