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

NCT01985958 | Completed Results DMC

• 1 other identifier: UPCC 14213
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Histological or Cytological Diagnosis of Pancreatic Carcinoma

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

  One Year

Study Arms (1)

Single arm

EXPERIMENTAL

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.

Device: Radiation therapy

Interventions

Radiation therapy DEVICE

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Interventions

Radiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Edgar Ben-Josef, M.D.
• Organization: University of Pennsylvania

Edgar.Ben-Josef@uphs.upenn.edu

215-662-3932

Study Officials

• Edgar Ben-Josef, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2013
• First Posted: November 18, 2013
• Study Start: July 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: December 1, 2019
• Last Updated: April 20, 2020
• Results First Posted: November 5, 2019

Record last verified: 2020-04

Locations

US (1)