Safety Trial of Vancomycin and Radiation for Early Stage Lung Cancer
This study is testing the safety of adding vancomycin, an antibiotic, to precision radiation therapy for people with early stage non-small cell lung cancer that has shown some growth (oligoprogressive). The study is looking at how safe this combination treatment is over 3 years. You might be able to join if you are over 18 and are planning to receive precision radiation for your lung cancer. The first part of this study is complete, and the current phase is a single-arm safety study. This means everyone in this phase will receive the same treatment.
- Study design
- This is a single-arm Phase 1 safety study, meaning all participants will receive the same treatment. The planned enrollment is 10 participants.
- What's involved
- You would receive vancomycin for 1 week before radiation and for 1 month after starting radiation. You would also be asked to provide stool and blood samples.
- Compensation
- Not stated in the trial record.
- Follow-up
- The safety of the treatment will be measured for 3 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Safety Trial of Antimicrobial Therapy and Precision Radiation Therapy in Patients With Oligoprogressive Non-small Cell Lung Cancer
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Steven Feigenberg, MD · PRINCIPAL_INVESTIGATOR · University of Pennsylvania
Who to contact
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What this trial measures
- Randomized Pilot: Th1 immune response measured by cytokine expression (IFN gamma).2 years
The primary endpoint is IFN-gamma cytokine expression at Day 30 (+/- 2) collection compared to the pre-radiation level. It will be analyzed using generalized linear mixed models.
- Randomized Pilot: the safety of the addition of vancomycin to Stereotactic Body Radiotherapy2 years
The primary safety endpoint is uncontrolled diarrhea, as defined by CTCAE v4.0 \> or = grade 3 (Increase of \>=7 stools per day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self-care ADL). This will be evaluated during treatment and at 1 month, 3 months, 6 months and 12 months.
- Safety Trial: the safety of the addition of vancomycin to precision hypofractionated radiation3 years
Safety Trial: The primary safety endpoint is uncontrolled diarrhea, as defined by CTCAE v5.0 \> or = grade 3 Increase of \>=7 stools per day over baseline; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self care ADL). This will be evaluated weekly during vancomycin use and RT, at 1 month post-vancomycin, 3 months post-vancomycin, 6 months post-vancomycin and 12 months post-vancomycin.