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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
125 mg, 4x daily for 5 weeks
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.
University of Pennsylvania
Philadelphia, Pennsylvania, United States
RECRUITINGRandomized Pilot: Th1 immune response measured by cytokine expression (IFN gamma).
The primary endpoint is IFN-gamma cytokine expression at Day 30 (+/- 2) collection compared to the pre-radiation level. It will be analyzed using generalized linear mixed models.
Time frame: 2 years
Randomized Pilot: the safety of the addition of vancomycin to Stereotactic Body Radiotherapy
The primary safety endpoint is uncontrolled diarrhea, as defined by CTCAE v4.0 \> or = grade 3 (Increase of \>=7 stools per day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self-care ADL). This will be evaluated during treatment and at 1 month, 3 months, 6 months and 12 months.
Time frame: 2 years
Safety Trial: the safety of the addition of vancomycin to precision hypofractionated radiation
Safety Trial: The primary safety endpoint is uncontrolled diarrhea, as defined by CTCAE v5.0 \> or = grade 3 Increase of \>=7 stools per day over baseline; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self care ADL). This will be evaluated weekly during vancomycin use and RT, at 1 month post-vancomycin, 3 months post-vancomycin, 6 months post-vancomycin and 12 months post-vancomycin.
Time frame: 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.