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Radiation Therapy

Antimicrobial Therapy + SBRT for Lung Cancer

Phase 1
Recruiting
Led By Abigail Berman, MD
Research Sponsored by Abramson Cancer Center at Penn Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient is planned to receive Stereotactic Body Radiotherapy (SBRT) to a biopsy-proven NSCLC
Age 18 years old or older
Must not have
Active infection with oral temperature >100°F
Patients on anti-diarrheal medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Summary

This trial tests if adding the antibiotic vancomycin to a precise radiation therapy can enhance the immune response in cancer patients by increasing certain immune signals.

Who is the study for?
This trial is for adults who can consent and are set to receive SBRT for confirmed NSCLC. It's not open to those with chronic constipation, recent use of steroids or immunosuppressants, antibiotics, antifungals, antivirals, or chemotherapy. People with uncontrolled GI disorders, certain infections or a history of major GI surgery aren't eligible.
What is being tested?
The study tests if adding vancomycin (an antibiotic) to SBRT boosts the Th1 immune response in early-stage non-small cell lung cancer patients by measuring specific immune signals like IFN gamma after treatment.
What are the potential side effects?
Potential side effects may include typical reactions to antibiotics such as stomach upset and diarrhea. SBRT might cause localized pain, skin changes at the radiation site, fatigue and rarely more serious complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for targeted radiation therapy for my lung cancer.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I currently have a fever over 100°F.
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I am currently taking medication for diarrhea.
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I have a documented history of HIV, hepatitis B, or hepatitis C.
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I am currently taking probiotics.
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I have chronic constipation, with bowel movements less frequent than every other day.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Randomized Pilot: Th1 immune response measured by cytokine expression (IFN gamma).
Randomized Pilot: the safety of the addition of vancomycin to Stereotactic Body Radiotherapy
Safety Trial: the safety of the addition of vancomycin to precision hypofractionated radiation

Trial Design

1Treatment groups
Experimental Treatment
Group I: Arm 1 - ExperimentalExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vancomycin
2020
Completed Phase 4
~7920

Find a Location

Who is running the clinical trial?

Abramson Cancer Center at Penn MedicineLead Sponsor
403 Previous Clinical Trials
155,985 Total Patients Enrolled
Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
105,876 Total Patients Enrolled
Abigail Berman, MDPrincipal InvestigatorAbramson Cancer Center of the University of Pennsylvania
2 Previous Clinical Trials
65 Total Patients Enrolled

Media Library

Stereotactic Body Radiation Therapy (SBRT) (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03546829 — Phase 1
Non-Small Cell Lung Cancer Research Study Groups: Arm 1 - Experimental
Non-Small Cell Lung Cancer Clinical Trial 2023: Stereotactic Body Radiation Therapy (SBRT) Highlights & Side Effects. Trial Name: NCT03546829 — Phase 1
Stereotactic Body Radiation Therapy (SBRT) (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03546829 — Phase 1
~3 spots leftby Dec 2026
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