Fecal Microbiota Transplantation in Treating Immune-Checkpoint Inhibitor Induced-Diarrhea or Colitis in Genitourinary Cancer Patients

Overview

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

  • 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

Detailed Description

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.

Interventions

  • 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

Primary 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.

Secondary Measures

  • 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

Inclusion Criteria

  • 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

Investigator Details

  • Lead Sponsor
    • M.D. Anderson Cancer Center
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Yinghong Wang, Principal Investigator, M.D. Anderson Cancer Center
  • Overall Contact(s)
    • Yinghong Wang, 281-221-9138, ywang59@mdanderson.org

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