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



Status:Recruiting
Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:6/7/2018
Start Date:April 24, 2018
End Date:December 24, 2020
Contact:Abigail Berman, MD
Email:PennCancerTrials@emergingmed.com
Phone:855-216-0098

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


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
We found this trial at
1
site
3400 Civic Center Blvd
Philadelphia, Pennsylvania 19104
(215) 662-6065
Principal Investigator: Abigail Berman, MD
Phone: 855-216-0098
Abramson Cancer Center of the University of Pennsylvania The Abramson Cancer Center of the University...
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mi
from
Philadelphia, PA
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