N/A
N=4
A Pilot Study to Evaluate Radiotherapy-Induced Anti-Tumor Immunity in Metastatic Carcinoma of the Pancreas
Histological or Cytological Diagnosis of Pancreatic Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT01985958 ↗Enrolled (actual)
4
Serious AEs
25.0%
Results posted
Nov 2019
Primary outcome: Primary: Number of Participants With Adverse Events — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Radiation therapy (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abramson Cancer Center at Penn Medicine
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
— | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01985958). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.