Status:
ACTIVE_NOT_RECRUITING
Stool Transplant to Control Treatment-related Diarrhea
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Fecal Microbiota Transplantation (FMT)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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. FMT uses a liquid preparat...
Eligibility Criteria
Inclusion
- ≥ 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
- 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
Key Trial Info
Start Date :
May 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2026
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04883762
Start Date
May 10 2021
End Date
May 1 2026
Last Update
October 9 2025
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065