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Safety Trial of Antimicrobial Therapy and Precision Radiation Therapy in Patients With Oligoprogressive Non-small Cell Lung Cancer

NCT03546829 · Abramson Cancer Center at Penn Medicine
In plain English

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About this study
The first phase of this study was an open label, randomized pilot study. Enrollment for this phase is now complete. The second phase is a single arm phase 1 safety study. Patients planned to undergo precision hypofractionated radiation to all sites of oligoprogression will receive vancomycin for 1 week before RT and for 1 month after start of RT, and asked to provide stool and blood samples as outlined in the Safety Trial study table.
Eligibility criteria
Randomized Pilot Inclusion * Patients planned to receive Stereotactic Body Radiotherapy (SBRT) to a biopsy-proven or clinically-suspected NSCLC * Age \>18 years' old * Patient capable of giving informed consent Randomized Pilot Exclusion * 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 * 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 Safety Trial Inclusion * Patients planned to receive precision hypofractionated radiation (SBRT or an ablative dose of radiation is used if SBRT is not appropriate or if insurance does not approve - i.e. \> 30 Gy in 10 fraction equivalent) to all sites of oligoprogressive NSCLC who progressed after 1st line systemic therapy for metastatic disease which included immunotherapy or a tyrosine kinase inhibitors (TKI) for NSCLC * The number of sites of progression are \< 5 sites. * Age \>18 years' old * Patient capable of giving informed consent Safety Trial Exclusion * Evidence of untreated CNS or leptomeningeal disease * Use of antibiotics, antifungal, antivirals or antiparasitics during the 4 weeks prior to registration * Active infection with oral temperature \>100°F * Use of oral 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 (S3). * Documented history of HIV, HBV or HCV * Patients on daily anti-diarrheal medications * Use of probiotics during the 4 weeks prior to radiotherapy or during radiotherapy
Study design
Enrollment target: 10 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2019-03-05
Estimated completion: 2028-12-31
Last updated: 2026-01-14
Interventions
Drug: VancomycinRadiation: Precision hypofractionated radiation
Primary outcomes
  • Randomized Pilot: Th1 immune response measured by cytokine expression (IFN gamma). (2 years)
  • Randomized Pilot: the safety of the addition of vancomycin to Stereotactic Body Radiotherapy (2 years)
  • Safety Trial: the safety of the addition of vancomycin to precision hypofractionated radiation (3 years)
Sponsor
Abramson Cancer Center at Penn Medicine · other
Contacts & investigators
ContactChing Lai · contact · ching.lai@pennmedicine.upenn.edu · 267-250-9244
ContactRadOnc Clinical Research Unit · contact · radonccru@pennmedicine.upenn.edu
InvestigatorSteven Feigenberg, MD · principal_investigator, University of Pennsylvania
All locations (1)
University of PennsylvaniaRecruiting
Philadelphia, Pennsylvania, United States
Safety Trial of Antimicrobial Therapy and Precision Radiation Therapy in Patients With Oligoprogressive Non-small Cell Lung Cancer · TrialPath