Fecal Microbiota Transplantation (FMT) for Immune-Checkpoint Inhibitor Induced-Diarrhea/Colitis in Genitourinary Cancer Patients
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.
Detailed 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 FMT on recurrence of immune-related diarrhea/colitis after resumption of immune checkpoint inhibitors (ICPI). * To assess immunological, molecular and microbiome changes in tissue/blood/stool. To study the efficacy and/ or benefit of PuraStat gel in the healing of mucosal ulcers and its hemostatic effect on bleeding lesions OUTLINE: Patients receive loperamide orally (PO). After 4 hours, patients undergo FMT via colonoscopy over 15-30 minutes. After completion of study treatment, patients are followed up at 2, 4, and 8 weeks, and then at 3 months.
Arms & interventions
- ProcedureFecal Microbiota Transplantation
Undergo FMT via colonoscopy
- DrugLoperamide
Given PO
Outcome measures
Primary
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.
Time frame: Up to 3 months post-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.
Time frame: At 2 weeks post-FMT
Secondary
Recurrent immune-related diarrhea/colitis within 3 months post-FMT after initially achieving clinical remission/response
Time frame: Up to 3 months post-FMT
Eligibility criteria
Study locations (1)
M D Anderson Cancer Center
Houston, Texas, 77030