Antimicrobial Therapy + SBRT for Lung Cancer

Recruiting at1 trial location

Overseen by Steven Feigenberg, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Abramson Cancer Center at Penn Medicine

Must be taking: Vancomycin

Must not be taking: Antibiotics, Antifungals, Antivirals, Antiparasitics

Disqualifiers: HIV, HBV, HCV, uncontrolled GI disorders, others

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

You may need to stop taking certain medications, such as antibiotics, antifungals, antivirals, antiparasitics, corticosteroids, methotrexate, immunosuppressive drugs, chemotherapy, anti-diarrheal medications, and probiotics, at least 4 weeks before joining the trial. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment Stereotactic Body Radiation Therapy (SBRT) for lung cancer?

Research shows that Stereotactic Body Radiation Therapy (SBRT) is effective for treating early-stage non-small cell lung cancer (NSCLC), especially for patients who cannot or choose not to have surgery. Studies indicate that SBRT can improve survival rates and control the cancer locally. ^{1 2 3 4 5}

Is the combination of antimicrobial therapy and SBRT generally safe for humans?

Stereotactic Body Radiation Therapy (SBRT) is generally well-tolerated for lung cancer, but it can cause side effects like fatigue, esophagitis (inflammation of the esophagus), pneumonitis (lung inflammation), and rib fractures. These side effects vary in severity, and efforts are ongoing to better understand and reduce them. ^{1 6 7 8 9}

How is the treatment of Stereotactic Body Radiation Therapy (SBRT) for lung cancer different from other treatments?

Stereotactic Body Radiation Therapy (SBRT) is unique because it delivers highly focused radiation doses to lung tumors with precision, minimizing damage to surrounding healthy tissue. This makes it particularly suitable for patients with early-stage non-small cell lung cancer (NSCLC) who cannot undergo surgery, offering high local control rates with acceptable side effects. ^{1 10 11 12 13}

Research Team

Steven Feigenberg, MD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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.

Inclusion Criteria

I am scheduled for targeted radiation therapy for my lung cancer.

I understand the details of the trial and can agree to participate.

I am 18 years old or older.

Exclusion Criteria

I have not taken antibiotics, antifungals, antivirals, or antiparasitics in the last 4 weeks.

I haven't started chemotherapy in the last 4 weeks or during my radiotherapy.

I have a documented history of HIV, hepatitis B, or hepatitis C.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive vancomycin for 1 week before and 1 month after precision hypofractionated radiation therapy

5 weeks

Weekly visits during treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Visits at 1, 3, 6, and 12 months post-treatment

Treatment Details

Interventions

• Stereotactic Body Radiation Therapy (SBRT) (Radiation Therapy)
• Vancomycin (Anti-infective Agent)

Trial Overview 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.

Participant Groups

Group I: Arm 1 - Experimental Experimental Treatment 2 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.

Stereotactic Body Radiation Therapy (SBRT) is already approved in Canada, Japan for the following indications:

Approved in Canada as Stereotactic Body Radiation Therapy for:

• Prostate cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer
• Spinal tumors

Approved in Japan as Stereotactic Body Radiation Therapy for:

• Prostate cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer
• Spinal tumors

Who Is Running the Clinical Trial?

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

Dr. Robert H. Vonderheide

Abramson Cancer Center at Penn Medicine

Chief Executive Officer since 2017

MD from Harvard Medical School

Dr. Bonnie Ky

Abramson Cancer Center at Penn Medicine

Chief Medical Officer

MD, MSCE from University of Pennsylvania

Abramson Cancer Center of the University of Pennsylvania

Lead Sponsor

Trials

360

Recruited

108,000+

Dr. Robert H. Vonderheide

Abramson Cancer Center of the University of Pennsylvania

Chief Executive Officer since 2017

DPhil in Immunology from Oxford University, MD from Harvard Medical School

Dr. Lawrence N. Shulman

Abramson Cancer Center of the University of Pennsylvania

Chief Medical Officer since 2017

MD from Harvard Medical School

Findings from Research

Stereotactic body radiation therapy (SBRT) demonstrated high effectiveness in treating early-stage non-small cell lung cancer (NSCLC), with 3-year local control, progression-free survival, and overall survival rates of 91%, 55%, and 71%, respectively, based on a study of 55 patients with 59 lesions.

The treatment was associated with minimal toxicity, with only a few cases of grade 2 pneumonitis and chest wall tenderness, indicating that SBRT is a safe option for patients who are not surgical candidates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiation Therapy for Stage I Non-Small Cell Lung Cancer: A Retrospective, Single-Center Study of 55 Patients. Bhandari, RP., Stanford, JD., Packianathan, S., et al.[2018]

Lung stereotactic body radiation therapy (SBRT) is an effective treatment option for early-stage non-small cell lung cancer (NSCLC) and is increasingly being used for more advanced cases.

The review highlights current treatment recommendations and planning for SBRT, indicating its growing role in managing lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung Stereotactic Body Radiation Therapy. Rehman, S., Roach, MC., Bradley, JD., et al.[2018]

In a study of 130 lung cancer patients treated with stereotactic body radiotherapy (SBRT), regimens of 10 Gy × 5 and 18 Gy × 3 showed significantly better local control and overall survival compared to the 9 Gy × 5 regimen.

The 10 Gy × 5 and 18 Gy × 3 treatments resulted in 100% local control at 1 year and 91% at 2 years, while the 9 Gy × 5 regimen had a local control rate of only 75% at 1 year and 50% at 2 years, highlighting the efficacy of higher dose regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose-response for stereotactic body radiotherapy in early-stage non-small-cell lung cancer. Olsen, JR., Robinson, CG., El Naqa, I., et al.[2022]

Stereotactic body radiation therapy (SBRT) is an effective treatment for early-stage non-small cell lung cancer (NSCLC) and is generally well tolerated, but it can lead to adverse effects ranging from mild fatigue to severe complications like pneumonitis or hemorrhage.

The review highlights the importance of understanding the mechanisms behind these adverse effects and discusses dosimetric constraints and strategies to mitigate treatment-related toxicities, especially as SBRT is increasingly used alongside chemoradiotherapy and immunotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The evolving toxicity profile of SBRT for lung cancer. Thompson, M., Rosenzweig, KE.[2023]

Stereotactic body radiation therapy (SBRT) is effective for treating inoperable early-stage non-small cell lung cancer, but radiation-induced lung toxicity (RILT) remains a significant concern, particularly in patients with interstitial lung disease.

The study found that a mean lung dose (MLD) of ≤8 Gy in 3 to 5 fractions and less than 10% to 15% of total lung volume receiving more than 20 Gy (V20) are associated with a lower risk of symptomatic RILT, indicating safe treatment parameters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Organs at Risk Considerations for Thoracic Stereotactic Body Radiation Therapy: What Is Safe for Lung Parenchyma? Kong, FS., Moiseenko, V., Zhao, J., et al.[2022]

A 68-year-old woman treated with stereotactic body radiation therapy (SBRT) for lung metastases experienced pathological vertebral fractures ten months post-treatment, highlighting a previously unreported adverse effect of SBRT.

Despite achieving a complete response of the metastatic disease without signs of radiation pneumonitis, the case emphasizes the need for oncologists to consider the risk of bone toxicity, particularly in older patients with potential low bone mineral density (BMD).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pathological vertebral fracture after stereotactic body radiation therapy for lung metastases. Case report and literature review. Rodríguez-Ruiz, ME., San Miguel, I., Gil-Bazo, I., et al.[2022]

Stereotactic body radiation therapy (SBRT) has evolved from stereotactic radiosurgery and is now widely used for treating lung cancer, demonstrating high local control rates.

Clinical studies indicate that SBRT has acceptable toxicity levels, making it a promising option for lung cancer treatment, with ongoing trials continuing to evaluate its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy (SBRT) for Stage I lung cancer. Nagata, Y., Kimura, T.[2018]

Stereotactic body radiotherapy (SBRT) is effective for treating early-stage non-small cell lung cancer (NSCLC) in patients who cannot undergo surgery, showing good outcomes and low toxicity for tumors located in the periphery.

However, the risk of severe toxicity increases for tumors near critical structures like the bronchial tree or mediastinum, highlighting the importance of careful dose-fractionation planning in these cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An optimal dose-fractionation for stereotactic body radiotherapy in peripherally, centrally and ultracentrally located early-stage non-small lung cancer. Zarębska, I., Harat, M.[2023]

Stereotactic body radiation therapy (SBRT) is a preferred treatment for early-stage non-small cell lung cancer (NSCLC) patients who cannot undergo surgery, but accurate lymph node staging is crucial for optimal patient selection.

Current staging methods like PET/CT and EBUS have limited sensitivity in detecting lymph node metastases, which can lead to undetected cancer spread and poorer outcomes; thus, invasive staging procedures are often necessary to improve detection and potentially enhance survival with adjuvant therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Undetected lymph node metastases in presumed early stage NSCLC SABR patients. Cerra-Franco, A., Diab, K., Lautenschlaeger, T.[2017]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiation Therapy for Stage I Non-Small Cell Lung Cancer: A Retrospective, Single-Center Study of 55 Patients. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Lung Stereotactic Body Radiation Therapy. [2018]

3. England pubmed.ncbi.nlm.nih.gov

The impact of histology in the outcomes of patients with early-stage non-small cell lung cancer (NSCLC) treated with stereotactic body radiation therapy (SBRT) and adjuvant chemotherapy. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Dose-response for stereotactic body radiotherapy in early-stage non-small-cell lung cancer. [2022]

5. Poland pubmed.ncbi.nlm.nih.gov

Local control and survival after stereotactic body radiation therapy of early-stage lung cancer patients in Slovenia. [2023]

6. China pubmed.ncbi.nlm.nih.gov

The evolving toxicity profile of SBRT for lung cancer. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Rib fracture after stereotactic radiotherapy for primary lung cancer: prevalence, degree of clinical symptoms, and risk factors. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Organs at Risk Considerations for Thoracic Stereotactic Body Radiation Therapy: What Is Safe for Lung Parenchyma? [2022]

9. England pubmed.ncbi.nlm.nih.gov

Pathological vertebral fracture after stereotactic body radiation therapy for lung metastases. Case report and literature review. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy (SBRT) for Stage I lung cancer. [2018]

11. Singapore pubmed.ncbi.nlm.nih.gov

An optimal dose-fractionation for stereotactic body radiotherapy in peripherally, centrally and ultracentrally located early-stage non-small lung cancer. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Undetected lymph node metastases in presumed early stage NSCLC SABR patients. [2017]

13. Korea (South) pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for early stage lung cancer. [2021]