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

Early Stage Non-Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03546829
• Other study ID #: UPCC 08517
• Status: Recruiting
• Phase: Early Phase 1
• Start date: April 24, 2018
• Est. completion date: December 31, 2027

Study information

• Verified date: December 2023
• Source: Abramson Cancer Center at Penn Medicine
• Contact: Ching Lai
• Phone: 267-250-9244
• Email: ching.lai[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Early Stage Non-Small Cell Lung Cancer
• Lung Neoplasms

Intervention

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,

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Th1 immune response measured by cytokine expression (IFN gamma).		2 years