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

Обзор

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.

Вмешательства

• Препарат Vancomycin
  125 mg, 4x daily for 5 weeks
• Лучевая терапия Precision 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.

Первичные конечные точки

• Randomized Pilot: Th1 immune response measured by cytokine expression (IFN gamma). [Срок оценки: 2 years]
• Randomized Pilot: the safety of the addition of vancomycin to Stereotactic Body Radiotherapy [Срок оценки: 2 years]
• Safety Trial: the safety of the addition of vancomycin to precision hypofractionated radiation [Срок оценки: 3 years]

Критерии участия

Randomized Pilot Inclusion

• 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

Randomized Pilot Exclusion

• Use of antibiotics, antifungal, antivirals or antiparasitics during the 4 weeks prior to registration
• Active infection with oral temperature >100°F
• Use of corticosteroids, methotrexate or immunosuppressive drugs during the 4 weeks prior to registration
• Use of chemotherapy during the 4 weeks prior to radiotherapy or during radiotherapy. Chemotherapy cannot begin before the collection of the 30-day post treatment sample (S4).
• Documented history of HIV, HBV or HCV
• Active uncontrolled gastrointestinal disorders such as inflammatory bowel disease, moderate/severe irritable bowel syndrome, persistent, infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhea of unknown etiology, Clostridium Difficile infection (within 2 years of lung cancer diagnosis) or Helicobacter Pylori infection (untreated)
• Major surgery of the GI tract, with the exception of cholecystectomy and appendectomy, in the past five years. Any major bowel resection at any time
• Patients on anti-diarrheal medications
• Patients on probiotics

Safety Trial Inclusion

• 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 for metastatic disease which included immunotherapy or a tyrosine kinase inhibitors (TKI) for NSCLC
• The number of sites of progression are < 5 sites.
• Age >18 years' old
• Patient capable of giving informed consent

Safety Trial Exclusion

• Evidence of untreated CNS or leptomeningeal disease
• Use of antibiotics, antifungal, antivirals or antiparasitics during the 4 weeks prior to registration
• Active infection with oral temperature >100°F
• Use of oral corticosteroids, methotrexate or immunosuppressive drugs during the 4 weeks prior to registration
• Use of chemotherapy during the 4 weeks prior to radiotherapy or during radiotherapy. Chemotherapy cannot begin before the collection of the 30-day post treatment sample (S3).
• Documented history of HIV, HBV or HCV
• Patients on daily anti-diarrheal medications
• Use of probiotics during the 4 weeks prior to radiotherapy or during radiotherapy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Pennsylvania — Philadelphia

Публикации

• Feigenberg SJ, Costabile F, Tanes C, Bittinger K, O'Connor R, Agarwal D, Skoufos G, Salaris S, Hatzigeorgiou A, Kostopoulos N, Lloyd S, Friedes C, Chen L, Yegya-Raman N, Cengel K, Levin W, Valentic B, Quarton T, Shestov AA, Berman A, Bradley J, Maity A, Koumenis C, Ben-Josef E, Facciabene A. Enhancing outcomes in medically inoperable early-stage NSCLC with gut-targeted antibiotics and stereotactic PMID 40639850

Идентификаторы

NCT: NCT03546829 · UPCC 08517 · 827551

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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