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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 7Eligibility criteria met