A Pilot Study To Evaluate Radiotherapy-Induced Anti-Tumor Immunity In Metastatic Carcinoma Of The Pancreas

Study Overview

A Pilot Study to Evaluate Radiotherapy-Induced Anti-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.

N/A

Histological or Cytological Diagnosis of Pancreatic Carcinoma

DEVICE: Radiation therapy

UPCC 14213

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2013-11-11	Results First Submitted 2019-10-15	Last Update Submitted that met QC Criteria 2020-04-03
First Submitted that Met QC Criteria 2013-11-15	Results First Submitted that Met QC Criteria 2019-11-04	Last Update Posted (ACTUAL) 2020-04-20
First Posted (ACTUAL) 2013-11-18	Results First Posted 2019-11-05	Last Verified 2020-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Diagnostic

Allocation:
Na

Interventional Model:
Single Group

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Single arm 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	DEVICE: Radiation therapy

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Single arm

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

DEVICE: Radiation therapy

Primary Outcome Measures	Measure Description	Time Frame
Number of Participants With Adverse Events		One Year

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Edgar Ben-Josef, MD, Abramson Cancer Center at Penn Medicine

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record