Clinical trial NCT03546829: Safety Trial of Antimicrobial Therapy and Precision Radiation Therapy in Patients With Oligoprogressive Non-small Cell Lung Cancer
Official title: Safety Trial of Antimicrobial Therapy and Precision Radiation Therapy in Patients With Oligoprogressive Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Early Stage Non-Small Cell Lung Cancer
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2018-06-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 criteria: 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 which included immunotherapy
* The number of sites of progression are \< 5 sites.
* Age \>18 years' old
* Patient capable of giving informed consent

Safety Trial Exclusion

* Evidence of 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 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
* 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
* Use of probiotics during the 4 weeks prior to radiotherapy or during radiotherapy

Primary outcomes:
measure: Randomized Pilot: Th1 immune response measured by cytokine expression (IFN gamma).
timeFrame: 2 years
measure: Randomized Pilot: the safety of the addition of vancomycin to Stereotactic Body Radiotherapy
timeFrame: 2 years
measure: Safety Trial: the safety of the addition of vancomycin to precision hypofractionated radiation
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Steven Feigenberg, MD
role: PRINCIPAL_INVESTIGATOR
References: