Safety Trial of Antimicrobial Therapy and Precision Radiation Therapy in Patients With Oligoprogressive Non-small Cell Lung Cancer
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 1 week, 1 month
- Procedures mentioned: Blood draws
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests the safety of vancomycin, an antibiotic, with focused radiation for non-small cell lung cancer that is growing in fewer than 5 spots after treatment. Patients take vancomycin for 1 week before radiation and 1 month after radiation starts, and give stool and blood samples. The first phase is full; the rules below are for the second phase, the safety 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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are older than 18.
- You can understand the study and agree to take part.
- You have non-small cell lung cancer that has spread and grew after your first treatment for the spread cancer. That treatment included immunotherapy, which helps the immune system fight cancer, or a TKI, a targeted cancer drug.
- Your cancer is growing in fewer than 5 spots.
- You plan to have focused, high-dose radiation to all spots where the cancer is growing.
Who can't join
- You have untreated cancer in the brain, spinal cord, or the tissue covering them.
- You used drugs for bacteria, fungi, viruses, or parasites in the 4 weeks before signing up.
- You have an active infection with a temperature above 100°F measured by mouth.
- You used steroid pills, methotrexate, or drugs that weaken the immune system in the 4 weeks before signing up.
- You had chemotherapy in the 4 weeks before radiation or will have it during radiation. Chemotherapy must wait until after the sample taken 30 days after treatment.
- You have a recorded history of HIV, hepatitis B, or hepatitis C.
- You take medicine for diarrhea every day.
- You used probiotics, products with helpful live germs, in the 4 weeks before radiation or will use them during radiation.
Simplified for readability. The official criteria below are what the study team uses.
Official 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 sites (1)
PA
- University of Pennsylvania · Philadelphia, PA 19104Ching Lai · Study contact · 267-250-9244 · ching.lai@pennmedicine.upenn.eduRadOnc Clinical Research Unit · Study contact · radonccru@pennmedicine.upenn.eduSteven Feigenberg, MD · Principal investigatorMore trials in Philadelphia