Description:
To determine if the addition of vancomycin to SBRT increases a Th1 immune response measured by cytokine expression (IFN gamma)
To determine if the addition of vancomycin to SBRT increases a Th1 immune response measured by cytokine expression (IFN gamma)
Recruiting
Early Phase 1
Drug | Synonyms | Arms |
---|---|---|
Vancomycin | Arm 1 - Experimental |
Name | Type | Description | Interventions |
---|---|---|---|
Arm 1 - Experimental | Experimental |
| |
Arm 2 - Control Arm | Active Comparator |
|
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 |
Measure: | Th1 immune response measured by cytokine expression (IFN gamma). |
Time Frame: | 2 years |
Safety Issue: | |
Description: |
Phase: | Early Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Abramson Cancer Center of the University of Pennsylvania |
May 18, 2021