Study Summary
This trial studies how well fecal microbiota transplantation works in treating diarrhea or colitis caused by certain medications. Fecal microbiota transplantation may reduce the incidence of these conditions.
Eligible Conditions
- Melanoma
- Lung Cancer
- Ovarian Cancer
- Uterine Cancer
- Breast Cancer
- Cervical Cancer
- Diarrhea
- Inflammatory Bowel Disease (IBD)
- Cancer of the Genitourinary System
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 1 Secondary · Reporting Duration: Up to 6 months after restarting ICPI
At 2 weeks post-FMT
Clinical response/remission of immune-related diarrhea/colitis
Week 8
Endoscopic remission (Mayo Clinic sub-score 0-1) of immune-related diarrhea/colitis
At 8 weeks post-FMT
Histological remission (resolution of active inflammation) of immune-related diarrhea/colitis
Up to 3 months
Frequencies of immune cells (CD4/8 T cells, regulatory T cells [Treg], macrophages, etc.) in tissue/blood/stool samples
Measure immunological measures (including levels of cytokines (IL-6, 17, TNF, etc.) in tissue/blood/stool samples
Month 3
Incidence of fecal microbiota transplantation (FMT)-related adverse events
Recurrent immune-related diarrhea/colitis within 3 months post-FMT after initially achieving clinical remission/response
Month 6
Recurrent immune-related diarrhea/colitis following FMT and immune checkpoint inhibitors (ICPI) resumption within 6 months of ICPI resumption
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Treatment (loperamide, colonoscopy, FMT)
1 of 1
Experimental Treatment
40 Total Participants · 1 Treatment Group
Primary Treatment: Treatment (loperamide, colonoscopy, FMT) · No Placebo Group · Phase 1
Treatment (loperamide, colonoscopy, FMT)Experimental Group · 2 Interventions: Loperamide, Fecal Microbiota Transplantation · Intervention Types: Drug, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Loperamide
FDA approved
Fecal Microbiota Transplantation
2016
Completed Phase 2
~330
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 6 months after restarting icpi
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,805 Previous Clinical Trials
1,790,339 Total Patients Enrolled
99 Trials studying Melanoma
25,455 Patients Enrolled for Melanoma
National Cancer Institute (NCI)NIH
13,084 Previous Clinical Trials
41,141,606 Total Patients Enrolled
543 Trials studying Melanoma
157,009 Patients Enrolled for Melanoma
Yinghong WangPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
900 Total Patients Enrolled
2 Trials studying Melanoma
900 Patients Enrolled for Melanoma
Eligibility Criteria
Age 18+ · All Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have received treatment with any ICPI agent(s) within the 2 weeks prior to testing.
Patient has been cleared for enrollment by Infectious Diseases consultant or treating physician if positive infection workup or screening tests (e.g
If you are over the age of 6 months, you must have a life expectancy of at least 6 months.
You have diarrhea and/or colitis symptoms based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5 within 45 days prior to date of FMT treatment without involvement of non- GI toxicity.
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Conditions
Cancer Related
Treatments