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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03546829
Recruitment Status : Suspended (Covid-19)
First Posted : June 6, 2018
Last Update Posted : May 18, 2020
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE May 23, 2018
First Posted Date  ICMJE June 6, 2018
Last Update Posted Date May 18, 2020
Actual Study Start Date  ICMJE April 24, 2018
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2018)
Th1 immune response measured by cytokine expression (IFN gamma). [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Pilot Trial of Antimicrobial Therapy and Stereotactic Body Radiation Therapy in Early-stage Non-small Cell Lung Cancer
Official Title  ICMJE Randomized Pilot Trial of Antimicrobial Therapy and Stereotactic Body Radiation Therapy in Early-stage Non-small Cell Lung Cancer
Brief Summary To determine if the addition of vancomycin to SBRT increases a Th1 immune response measured by cytokine expression (IFN gamma)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Early Stage Non-Small Cell Lung Cancer
Intervention  ICMJE
  • 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,
Study Arms  ICMJE
  • Experimental: Arm 1 - Experimental
    Interventions:
    • Drug: Vancomycin
    • Radiation: Stereotactic Body Radiation Therapy (SBRT)
  • Active Comparator: Arm 2 - Control Arm
    Interventions:
    • Drug: Vancomycin
    • Radiation: Stereotactic Body Radiation Therapy (SBRT)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: May 23, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03546829
Other Study ID Numbers  ICMJE UPCC 08517
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Abramson Cancer Center of the University of Pennsylvania
Study Sponsor  ICMJE Abramson Cancer Center of the University of Pennsylvania
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Abigail Berman, MD Abramson Cancer Center of the University of Pennsylvania
PRS Account Abramson Cancer Center of the University of Pennsylvania
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP