RecruitingPhase 1NCT03546829

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


Sponsor

Abramson Cancer Center at Penn Medicine

Enrollment

10 participants

Start Date

Mar 5, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether taking antibiotics around the time of precision radiation therapy (called SBRT — a focused, high-dose form of radiation) affects how well the treatment works in patients with non-small cell lung cancer, potentially through changes to gut bacteria. **You may be eligible if...** - You are over 18 years old - You have non-small cell lung cancer (either confirmed by biopsy or suspected based on scans) - You are scheduled to receive SBRT or a similar ablative (high-dose focused) radiation treatment - You are able to give informed consent **You may NOT be eligible if...** - You have taken antibiotics, antifungals, antivirals, or antiparasitics in the 4 weeks before enrolling - You have an active infection with a fever - You have been on steroids, methotrexate, or other immune-suppressing drugs in the past 4 weeks - You recently had chemotherapy or will have it during the radiation period - You have a history of HIV, hepatitis B, or hepatitis C - You have uncontrolled inflammatory bowel disease, persistent diarrhea, or a recent C. difficile infection - You have had major bowel surgery in the past 5 years - You currently take anti-diarrheal medications or probiotics Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVancomycin

125 mg, 4x daily for 5 weeks

RADIATIONPrecision hypofractionated radiation

Patients planned to undergo precision hypofractionated radiation to all sites of oligoprogression and 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.


Locations(1)

University of Pennsylvania

Philadelphia, Pennsylvania, United States

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NCT03546829