Back to resultsA Pilot Study to Evaluate Radiotherapy-Induced Anti-Tumor Immunity in Metastatic Carcinoma of the Pancreas
Primary Purpose
Histological or Cytological Diagnosis of Pancreatic Carcinoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Radiation therapy
Sponsored by
About this trial
This is an interventional diagnostic trial for Histological or Cytological Diagnosis of Pancreatic Carcinoma
Eligibility 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.
Sites / Locations
- Abramson Cancer Center of the University of Pennsylvania
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single arm
Arm Description
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.
Outcomes
Primary Outcome Measures
Number of Participants With Adverse Events
Secondary Outcome Measures
Full Information
NCT ID
NCT01985958
First Posted
November 11, 2013
Last Updated
April 3, 2020
Sponsor
Abramson Cancer Center at Penn Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01985958
Brief Title
A Pilot Study to Evaluate Radiotherapy-Induced Anti-Tumor Immunity in Metastatic Carcinoma of the Pancreas
Official Title
A Pilot Study to Evaluate Radiotherapy-Induced Ant-Tumor Immunity in Metastatic Carcinoma of the Pancreas
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
December 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Histological or Cytological Diagnosis of Pancreatic Carcinoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Radiation therapy
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Time Frame
One Year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edgar Ben-Josef, MD
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study to Evaluate Radiotherapy-Induced Anti-Tumor Immunity in Metastatic Carcinoma of the Pancreas
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