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

Not Applicable

Completed

• Conditions: Histological or Cytological Diagnosis of Pancreatic Carcinoma
• Interventions: Device: Radiation therapy

• Registration Number: NCT01985958
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-11-11
• Study First Submitted QC: 2013-11-15
• Study First Posted: 2013-11-18
• Primary Completion: 2015-09
• Results First Submitted: 2019-10-15
• Results First Submitted QC: 2019-11-04
• Results First Posted: 2019-11-05
• Study Completion: 2019-12
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-03
• Last Update Posted: 2020-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	Radiation therapy	In this trial, we will deliver low-dose (8Gy in a single fraction) radiotherapy (SBRT or any other acceptable delivery method as determined by the treating physician) for palliation of symptoms in patients in whom it is clinically indicated. This dose is far lower than what has been used in the definitive settings described above. This is a safe dose, and is entirely consistent with the dose range used for routine palliation. Therefore, this trial does not involve an experimental intervention; the research aspect of this protocol is the evaluation of the immune response to clinically indicated palliative radiotherapy.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	One Year

Trial Locations

Locations (1)

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States