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

• Status: Recruiting
• Trial end date: 2021-07-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Antidiarrheals; Loperamide

Criteria

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.