Safety of combining antimicrobial therapy with precision radiation for lung cancer
Safety Trial of Antimicrobial Therapy and Precision Radiation Therapy in Patients With Oligoprogressive Non-small Cell Lung Cancer
This study is testing if adding an antibiotic called vancomycin to a specific type of radiation treatment can safely help people with early-stage lung cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Abramson Cancer Center at Penn Medicine Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation, methotrexate |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT03546829 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety of using vancomycin alongside precision hypofractionated radiation therapy in patients with oligoprogressive non-small cell lung cancer (NSCLC). In the second phase, participants will receive vancomycin for one week prior to radiation treatment and for one month afterward, while providing stool and blood samples for analysis. The study aims to assess the safety and potential benefits of this combined approach in managing early-stage NSCLC.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with biopsy-proven or clinically-suspected early-stage non-small cell lung cancer who are scheduled for stereotactic body radiotherapy.
Not a fit: Patients with active infections, recent antibiotic use, or certain gastrointestinal disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance treatment outcomes for patients with oligoprogressive NSCLC by improving the effectiveness of radiation therapy.
How similar studies have performed: While this specific combination of treatments is novel, similar approaches in using antimicrobial therapy with radiation have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Philadelphia, Pennsylvania
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Steven Feigenberg, MD — University of Pennsylvania
- Study coordinator: Ching Lai
- Email: ching.lai@pennmedicine.upenn.edu
- Phone: 267-250-9244
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.