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

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

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

Conditions
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Early Stage Non-Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Vancomycin
* Radiation: Stereotactic Body Radiation Therapy (SBRT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1 - Experimental<br> | Drug: Vancomycin<br>* 125 mg, 4x daily for 5 weeks<br>Radiation: Stereotactic Body Radiation Therapy (SBRT)<br>* Patients planned to undergo SBRT to a lung lesion will be randomized to either vancomycin for 1 week before RT and for 1 month after start of RT,<br>|
| Active Comparator: Arm 2 - Control Arm<br> | Drug: Vancomycin<br>* 125 mg, 4x daily for 5 weeks<br>Radiation: Stereotactic Body Radiation Therapy (SBRT)<br>* Patients planned to undergo SBRT to a lung lesion will be randomized to either vancomycin for 1 week before RT and for 1 month after start of RT,<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Th1 immune response measured by cytokine expression (IFN gamma). |  | 2 years |