Clinical Trials /

Randomized Pilot Trial of Antimicrobial Therapy and Stereotactic Body Radiation Therapy in Early-stage Non-small Cell Lung Cancer

NCT03546829

Description:

To determine if the addition of vancomycin to SBRT increases a Th1 immune response measured by cytokine expression (IFN gamma)

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Early Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Randomized Pilot Trial of Antimicrobial Therapy and Stereotactic Body Radiation Therapy in Early-stage Non-small Cell Lung Cancer
  • Official Title: Randomized Pilot Trial of Antimicrobial Therapy and Stereotactic Body Radiation Therapy in Early-stage Non-small Cell Lung Cancer

Clinical Trial IDs

  • ORG STUDY ID: UPCC 08517
  • NCT ID: NCT03546829

Conditions

  • Early Stage Non-Small Cell Lung Cancer

Interventions

DrugSynonymsArms
VancomycinArm 1 - Experimental

Purpose

To determine if the addition of vancomycin to SBRT increases a Th1 immune response measured by cytokine expression (IFN gamma)

Trial Arms

NameTypeDescriptionInterventions
Arm 1 - ExperimentalExperimental
  • Vancomycin
Arm 2 - Control ArmActive Comparator
  • Vancomycin

Eligibility Criteria

        Inclusion Criteria:

          -  Patient is planned to receive Stereotactic Body Radiotherapy (SBRT) to a biopsy-proven
             NSCLC

          -  Age 18 years old or older

          -  Patient capable of giving informed consent

        Exclusion Criteria:

          -  Use of antibiotics, antifungal, antivirals or antiparasitics during the 4 weeks prior
             to registration

          -  Active infection with oral temperature >100°F

          -  Use of corticosteroids, methotrexate or immunosuppressive drugs during the 4 weeks
             prior to registration

          -  Use of chemotherapy during the 4 weeks prior to radiotherapy or during radiotherapy.
             Chemotherapy cannot begin before the collection of the 30-day post treatment sample
             (S4).

          -  Documented history of HIV, HBV or HCV

          -  Chronic constipation (bowel movements less frequent than every other day)

          -  Active uncontrolled gastrointestinal disorders such as inflammatory bowel disease,
             moderate/severe irritable bowel syndrome, persistent, infectious gastroenteritis,
             colitis or gastritis, persistent or chronic diarrhea of unknown etiology, Clostridium
             Difficile infection (within 2 years of lung cancer diagnosis) or Helicobacter Pylori
             infection (untreated)

          -  Major surgery of the GI tract, with the exception of cholecystectomy and appendectomy,
             in the past five years. Any major bowel resection at any time

          -  Patients on anti-diarrheal medications

          -  Patients on probiotics
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Th1 immune response measured by cytokine expression (IFN gamma).
Time Frame:2 years
Safety Issue:
Description:

Details

Phase:Early Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Abramson Cancer Center of the University of Pennsylvania

Last Updated

November 5, 2019