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

Who is this study for? Patients with Non-Small Cell Lung Cancer
What treatments are being studied? Vancomycin+Stereotactic Body Radiation Therapy (SBRT)
Status: Recruiting
Location: See location...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• 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 which included immunotherapy

• The number of sites of progression are \< 5 sites.

• Age \>18 years' old

• Patient capable of giving informed consent

Locations
United States
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Contact Information
Primary
Ching Lai
ching.lai@pennmedicine.upenn.edu
267-250-9244
Backup
RadOnc Clinical Research Unit
radonccru@pennmedicine.upenn.edu
Time Frame
Start Date: 2019-03-05
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 10
Treatments
Experimental: Arm 1 - Experimental
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.
Sponsors
Leads: Abramson Cancer Center at Penn Medicine

This content was sourced from clinicaltrials.gov