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.
Full Title of Study: “Fecal Microbiota Transplantation (FMT) for Immune-Checkpoint Inhibitor Induced-Diarrhea/Colitis in Genitourinary Cancer Patients”
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: July 31, 2021
PRIMARY OBJECTIVES: I. To assess the safety and tolerability of fecal microbiota transplantation (FMT). II. To assess the efficacy of FMT for clinical remission/response of immune-related diarrhea/colitis. SECONDARY OBJECTIVES: I. To measure the recurrence rate after achieving clinical remission/response of immune-related diarrhea/colitis. EXPLORATORY OBJECTIVES: I. To assess the efficacy of FMT to achieve endoscopic remission of immune-related diarrhea/colitis. II. To assess the efficacy of FMT to achieve histological remission of immune-related diarrhea/colitis. III. To assess the efficacy of FMT on recurrence of immune-related diarrhea/colitis after resumption of immune checkpoint inhibitors (ICPI). IV. To assess immunological, molecular and microbiome changes in tissue/blood/stool. 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.
- Procedure: Fecal Microbiota Transplantation
- Undergo FMT via colonoscopy
- Drug: Loperamide
- Given PO
Arms, Groups and Cohorts
- Experimental: Treatment (loperamide, colonoscopy, FMT)
- Patients receive loperamide PO. After 4 hours, patients undergo FMT via colonoscopy over 15-30 minutes.
Clinical Trial Outcome Measures
- Incidence of fecal microbiota transplantation (FMT)-related adverse events
- Time Frame: Up to 3 months post-FMT
- 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
- Time Frame: At 2 weeks post-FMT
- 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
- Time Frame: Up to 3 months post-FMT
- Recurrent immune-related diarrhea colitis events occurring post-FMT are recorded throughout the follow-up period.
Participating in This Clinical Trial
- Diagnosis of any type of genitourinary malignancy. – Treatment with any ICPI agent(s). – New onset of grade 2 or above ICPI-induced diarrhea/colitis. – Ability to understand and willingness to sign an informed consent form. – Life expectancy > 6 months. Exclusion Criteria:
- Diagnosed infection at the onset of ICPI- induced diarrhea/colitis requiring antibiotics. – History of inflammatory bowel disease, and/or radiation enteritis or colitis. – Pregnant and breastfeeding women. – Women who have positive urine or serum pregnancy test or refuse to do pregnancy test. – Immunosuppressive treatment at onset of ICPI-induced diarrhea/colitis. – Any medical conditions (e.g. severe heart failure, brain hemorrhage, septic shock, etc.) that are high risk for colonoscopy procedure by the assessment of the study primary investigator (PI) or Co-PIs.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- M.D. Anderson Cancer Center
- National Cancer Institute (NCI)
- Provider of Information About this Clinical Study
- Overall Official(s)
- Yinghong Wang, Principal Investigator, M.D. Anderson Cancer Center
- Overall Contact(s)
- Yinghong Wang, 281-221-9138, email@example.com
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