A Pilot Study to Evaluate Radiotherapy-Induced Anti-Tumor Immunity in Metastatic Carcinoma of the Pancreas
Completed · Not applicable
Conditions studied: Histological or Cytological Diagnosis of Pancreatic Carcinoma
In brief
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.
Key facts
- Study ID
- NCT01985958
- Run by
- Abramson Cancer Center at Penn Medicine
- People needed
- 4
- Starts
- 2013-07-01
- Expected to finish
- 2019-12-01
- Last updated by the study team
- 2020-04-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Abramson Cancer Center of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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