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

Not Applicable

Completed

Brief Summary: 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.

Recruitment & Eligibility

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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	One Year

Secondary Outcome Measures

Name	Time	Method

Locations (1): Abramson Cancer Center of the University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
Abramson Cancer Center of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States