This trial studies how well fecal microbiota transplantation works in treating diarrhea or colitis (inflammation of the intestines) that is caused by certain types of medications (called immune-checkpoint inhibitors) in patients with genitourinary cancer. Fecal microbiota transplantation may effectively reduce the incidence of immune checkpoint inhibitor-induced diarrhea/colitis.
Diagnosis of any type of genitourinary (kidney, bladder and prostate), melanoma, non-melanoma skin cancer, lung, head & neck, sarcoma/lymphoma, gastrointestinal system (luminal GI, hepatobiliary, pancreas), gynecology system (ovarian, uterine, cervical), and breast malignancies
Treatment with any ICPI agent(s)
Participants with new onset of ≥ grade 2 ICPI-induced diarrhea and/or colitis symptoms based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5 within 45 days prior to date of FMT treatment without involvement of non- GI toxicity
Participants with a history of steroid use before FMT can be allowed if last dose was > 30 days prior to FMT treatment or treatment duration was for <7 days beyond one week prior to FMT treatment
Age younger than 18 years
Participants with persistent GI infection confirmed with positive stool test(s) despite completing 5 days of antibiotics prior to initiation of protocol therapy
History of inflammatory bowel disease, and/or radiation enteritis or colitis with active disease status at the time of study treatment initiation
Pregnant and breastfeeding women
Single group
Fecal Microbiota Transplantation
Procedure/SurgeryUndergo FMT via colonoscopy
Loperamide
DrugGiven PO
Incidence of fecal microbiota transplantation (FMT)-related adverse events
Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5. All events are recorded with grade and attribution to FMT.
Clinical response/remission of immune-related diarrhea/colitis
Clinical remission of immune related events defined as improvement of symptoms of grade 1 or lower within 2 weeks post-FMT. Clinical partial response of immune related diarrhea/colitis defined as improvement of diarrhea/colitis to a lower grade than the initial presentation but not meeting criteria of clinical remission at 2 week post-FMT time point.
Recurrent immune-related diarrhea/colitis within 3 months post-FMT after initially achieving clinical remission/response
Recurrent immune-related diarrhea colitis events occurring post-FMT are recorded throughout the follow-up period.
Endoscopic remission (Mayo Clinic sub-score 0-1) of immune-related diarrhea/colitis
Endoscopic remission is defined as Mayo Clinic endoscopic subscore 0 or 1 (absence of ulcers, with or without mild erythema, friability and decreased vascular pattern).
Histological remission (resolution of active inflammation) of immune-related diarrhea/colitis
Histological remission is defined resolution of active inflammation on biopsy sample.
Recurrent immune-related diarrhea/colitis following FMT and immune checkpoint inhibitors (ICPI) resumption within 6 months of ICPI resumption
Recurrent immune-related diarrhea colitis events occurring post-FMT will be recorded throughout the follow-up period.
Measure immunological measures (including levels of cytokines (IL-6, 17, TNF, etc.) in tissue/blood/stool samples
Blood, stool, and colon tissues will be collected from at each scheduled time point. Markers of interest for immunological and biological profiles include levels of cytokines (IL-6, 17, TNF, etc). Special attention will focus on Bacteroidetes, Akkermansia, and Blautia.
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M.D. Anderson Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
