Fecal Microbiota Transplantation (FMT) for Immune-Checkpoint Inhibitor Induced-Diarrhea/Colitis in Genitourinary Cancer Patients
M.D. Anderson Cancer Center
Summary
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.
Description
PRIMARY OBJECTIVES: * To assess the safety and tolerability of fecal microbiota transplantation (FMT). * To assess the efficacy of FMT for clinical remission/response of immune-related diarrhea/colitis. SECONDARY OBJECTIVES: \- To measure the recurrence rate after achieving clinical remission/response of immune-related diarrhea/colitis. EXPLORATORY OBJECTIVES: * To assess the efficacy of FMT to achieve endoscopic remission of immune-related diarrhea/colitis. * To assess the efficacy of FMT to achieve histological remission of immune-related diarrhea/colitis. * To assess the efficacy of FM…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. 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 2. Treatment with any ICPI agent(s) 3. 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 4. Par…
Interventions
- ProcedureFecal Microbiota Transplantation
Undergo FMT via colonoscopy
- DrugLoperamide
Given PO
Location
- M D Anderson Cancer CenterHouston, Texas