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

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abramson Cancer Center of the University of Pennsylvania
• Treatments: Anti-Bacterial Agents; Anti-Infective Agents; Vancomycin

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