Stool Transplant to Control Treatment-related Diarrhea
Study Details
Study Description
Brief Summary
This study will test the safety, effectiveness, and feasibility of a treatment called fecal microbiota transplantation (FMT) to reduce the symptoms of ICI-related diarrhea.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Fecal Microbiota Transplantation (FMT) Study subjects will undergo standard bowel preparation and diagnostic colonoscopy with routine biopsies for pathologic assessment. FMT will be performed at the proximal extent of the colon reached, according to the same protocol used in prior randomized studies. FMT will use healthy donor stool provided by OpenBiome, a nonprofit 501(c)(3) organization that provides clinicians and hospitals with screened, filtered and frozen stool to be used for FMT. Routine clinical and research biopsies will be collected during the FMT colonoscopy procedure. |
Biological: Fecal Microbiota Transplantation (FMT)
Undergo FMT via colonoscopy.
|
Outcome Measures
Primary Outcome Measures
- Incidence of fecal microbiota transplantation (FMT)-related adverse events [for 7 days after each FMT]
will be grading according to CTCAE 5.0.1
Eligibility Criteria
Criteria
Inclusion Criteria:
-
≥ 18 years old
-
Patient has been treated with immune checkpoint inhibitors (ICI), including anti-CTLA-4, anti-PD-1 and anti-PDL-1 therapy for any malignant indication
-
Patient has developed diarrhea ≥ Grade 2 attributed to ICI
-
Patient has diarrhea ≥ Grade 2 attributed to ICI, that persists despite treatment with corticosteroids for at least 72 hours and/or at least one dose of a biologic medication, such as infliximab or vedolizumab, with symptoms that persist or recur at least 72 hours post-infusion ° If no to the above, patient has a contraindictation to immunosuppressive treatment
Exclusion Criteria:
-
Active GI infection, including untreated viral, bacterial or fungal or alternative identified cause(s) of diarrhea.
-
Antibiotic exposure within 48 hours prior to FMT
-
Expected prolonged compromised immunity indicated by at least one of the below:
-
Known HIV infection with CD4 count <240
-
ANC <1000/mm3 (use of growth factors to raise ANC is acceptable)
-
Seronegative for EBV or CMV (i.e. EBV IgG negative or CMV IgG negative)
-
Contraindications to anesthesia for procedure indicated by at least one of the below:
-
Serious cardiopulmonary comorbidities
-
Inability to tolerate anesthesia
-
Pregnancy
-
Patient is pregnant
-
Women of childbearing potential should not have plans to became pregnant or breastfeed an infant and must agree to use a highly effective method of birth control until 2 months after treatment with FMT (e.g. barrier method, oral or parenteral contraceptives, a vasectomized partner, or abstinence from sexual intercourse)
-
Severe food allergies
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
Sponsors and Collaborators
- Memorial Sloan Kettering Cancer Center
Investigators
- Principal Investigator: David Faleck, MD, Memorial Sloan Kettering Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 20-242