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

• Sponsor: Abramson Cancer Center of the University of Pennsylvania (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03546829
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 116.2
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Early Stage Non-Small Cell Lung Cancer	Drug: Vancomycin; Radiation: Stereotactic Body Radiation Therapy (SBRT)	Early Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized Pilot Trial of Antimicrobial Therapy and Stereotactic Body Radiation Therapy in Early-stage Non-small Cell Lung Cancer
• Actual Study Start Date: Apr 24, 2018
• Anticipated Primary Completion Date: Dec 31, 2026
• Anticipated Study Completion Date: Dec 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 - Experimental	Drug: Vancomycin; 125 mg, 4x daily for 5 weeks; Radiation: Stereotactic Body Radiation Therapy (SBRT); 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,
Active Comparator: Arm 2 - Control Arm	Drug: Vancomycin; 125 mg, 4x daily for 5 weeks; Radiation: Stereotactic Body Radiation Therapy (SBRT); 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,

Outcome Measures

Primary Outcome Measures

1. Th1 immune response measured by cytokine expression (IFN gamma). [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• Abramson Cancer Center of the University of Pennsylvania

Investigators

• Principal Investigator: Abigail Berman, MD, Abramson Cancer Center of the University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abramson Cancer Center of the University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT03546829
• Other Study ID Numbers: UPCC 08517
• First Posted: Jun 6, 2018
• Last Update Posted: Dec 6, 2021
• Last Verified: Dec 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Vancomycin

Study Results

No Results Posted as of Dec 6, 2021