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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

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 24, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


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,




Primary Outcome Measures :
  1. Th1 immune response measured by cytokine expression (IFN gamma). [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03546829


Locations
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United States, Pennsylvania
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
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Principal Investigator: Abigail Berman, MD Abramson Cancer Center of the University of Pennsylvania
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Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03546829    
Other Study ID Numbers: UPCC 08517
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents