A Pilot Study to Evaluate Radiotherapy-Induced Anti-Tumor Immunity in Metastatic Carcinoma of the Pancreas
Conditions
Histological or Cytological Diagnosis of Pancreatic Carcinoma
Conditions: official terms
Carcinoma - Pancreatic Neoplasms
Study Type
Interventional
Study Phase
N/A
Study Design
Intervention Model: Single Group Assignment, Primary Purpose: Diagnostic
Intervention
Name: Radiation therapy
Type: Device
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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.
Location
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Status: Recruiting
Contact: Edgar Ben-Josef, MD - 855-216-0098 - PennCancerTrials@emergingmed.com
Start Date
July 2013
Completion Date
July 2015
Sponsors
Abramson Cancer Center of the University of Pennsylvania
Source
Abramson Cancer Center of the University of Pennsylvania
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page