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