A Pilot Study to Evaluate Radiotherapy-Induced Anti-Tumor Immunity in Metastatic Carcinoma of the Pancreas

A Pilot Study to Evaluate Radiotherapy-Induced Ant-Tumor Immunity in Metastatic Carcinoma of the Pancreas

Primary Objective: To estimate the rate at which radiotherapy to the primary or a metastatic lesion produces an immune response in patients with metastatic carcinoma of the pancreas.

Secondary Objectives: To characterize the kinetics of an immune response induced by radiotherapy. To characterize the dependency of the immune response on prior exposure to chemotherapy.

Inclusion Criteria:

• Histological or cytological diagnosis of pancreatic carcinoma
• Patients ≥ 18 years of age
• Eastern Cooperative Oncology Group (ECOG) performance status 0,1,or 2
• Patients must have distant metastatic disease (stage 4)
• Satisfactory organ and bone marrow function as defined by: Absolute neutrophil count> 1,000/uL, Platelets > 75,000uL Hemoglobin > 9 Bilirubin ≤ 2.0x the institutional normal upper limit unless secondary to bile duct obstruction by tumor,
• Creatinine ≤ 1.5x the institutional normal upper limit
• Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 5x the institutional normal upper limit.
• A clinical recommendation for radiotherapy to the primary or a metastatic lesion had been made.
• Must be able to provide informed consent.

Exclusion Criteria:

• No prior radiation to the area planned for radiotherapy
• Active invasive cancer other than pancreatic adenocarcinoma. Non-melanoma skin cancer, superficial cervical or bladder cancer and prostate cancer with PSA level < 1.0 are not excluded.
• Known HIV, HCV and/or HBV positive (by patient report/medical record)
• Patients with ongoing or active infection
• Planned concurrent treatment with systemic high dose corticosteroids.
• Received an anticancer treatment (systemic therapy or radiation therapy)within 21 days prior to enrollment.
• Immunotherapy (e.g. monoclonal antibodies)within 21 days prior to enrollment.
• Immunosuppressive therapies (e.g. steroids, cyclosporine) are not permitted.