Back to resultsRandomized Pilot Trial of Antimicrobial Therapy and Stereotactic Body Radiation Therapy in Early-stage Non-small Cell Lung Cancer
Primary Purpose
Early Stage Non-Small Cell Lung Cancer
Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Vancomycin
Stereotactic Body Radiation Therapy (SBRT)
Sponsored by
About this trial
This is an interventional treatment trial for Early Stage Non-Small Cell Lung Cancer
Eligibility Criteria
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
Sites / Locations
- Abramson Cancer Center of the University of PennsylvaniaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm 1 - Experimental
Arm 2 - Control Arm
Arm Description
Outcomes
Primary Outcome Measures
Th1 immune response measured by cytokine expression (IFN gamma).
Secondary Outcome Measures
Full Information
NCT ID
NCT03546829
First Posted
May 23, 2018
Last Updated
November 1, 2022
Sponsor
Abramson Cancer Center at Penn Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03546829
Brief Title
Randomized Pilot Trial of Antimicrobial Therapy and Stereotactic Body Radiation Therapy in Early-stage Non-small Cell Lung Cancer
Official Title
Randomized Pilot Trial of Antimicrobial Therapy and Stereotactic Body Radiation Therapy in Early-stage Non-small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 24, 2018 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To determine if the addition of vancomycin to SBRT increases a Th1 immune response measured by cytokine expression (IFN gamma)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Stage Non-Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1 - Experimental
Arm Type
Experimental
Arm Title
Arm 2 - Control Arm
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Intervention Description
125 mg, 4x daily for 5 weeks
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiation Therapy (SBRT)
Intervention Description
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,
Primary Outcome Measure Information:
Title
Th1 immune response measured by cytokine expression (IFN gamma).
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ching Lai
Phone
267-250-9244
Email
ching.lai@pennmedicine.upenn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Feigenberg, MD
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abigail Berman, MD
Phone
855-216-0098
Email
PennCancerTrials@emergingmed.com
First Name & Middle Initial & Last Name & Degree
Abigail Berman, MD
12. IPD Sharing Statement
Learn more about this trial
Randomized Pilot Trial of Antimicrobial Therapy and Stereotactic Body Radiation Therapy in Early-stage Non-small Cell Lung Cancer
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