Breast Cancer Clinical Trial
Official title:
Fecal Microbiota Transplantation (FMT) for Immune-Checkpoint Inhibitor Induced-Diarrhea/Colitis in Genitourinary Cancer Patients
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Diagnosis of any type of genitourinary (kidney, bladder and prostate), melanoma, non-melanoma skin cancer, lung, head & neck, sarcoma/lymphoma, gastrointestinal system (luminal GI, hepatobiliary, pancreas), gynecology system (ovarian, uterine, cervical), and breast malignancies 2. Treatment with any ICPI agent(s) 3. Participants with new onset of = grade 2 ICPI-induced 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 4. Participants with a history of steroid use before FMT can be allowed if last dose was > 30 days prior to FMT treatment or treatment duration was for <7 days beyond one week prior to FMT treatment 5. Participants with a history of immunosuppressant (Infliximab, Vedolizumab etc) use before FMT can be allowed if last dose was administered = 3 months prior to FMT treatment when used for the treatment of conditions other than for ICI- induced GI toxicities (e.g., Infliximab is used in the treatment of Crohn's disease, rheumatoid arthritis, plaque psoriasis, and Vedolizumab is used in treating ulcerative colitis) 6. No concern for active concomitant GI infection at the time of initiation of protocol therapy as confirmed by stool tests or as per the treating physician based on clinical presentation 7. Participant has been cleared for enrollment by Infectious Diseases consultant or treating physician if positive infection workup or screening tests (e.g., lifelong positive T-spot due to BCG inoculation, chronic colonization) prior to initiation of protocol therapy 8. Ability to understand and willingness to sign an informed consent form 9. Life expectancy > 6 months Exclusion Criteria 1. Age younger than 18 years 2. Participants with persistent GI infection confirmed with positive stool test(s) despite completing 5 days of antibiotics prior to initiation of protocol therapy 3. History of inflammatory bowel disease, and/or radiation enteritis or colitis with active disease status at the time of study treatment initiation 4. Pregnant and breastfeeding women 5. Women who have positive urine or serum pregnancy test or refuse to do pregnancy test unless last menstrual cycle was > 1 year prior to consent and/ or clear documentation states that participant is peri- or post-menopausal or there has been recent supporting objective evidence of 'no pregnancy' status (e.g. blood or imaging) within 30 days prior to date of study treatment 6. Immunosuppressive treatment at onset of ICPI-induced diarrhea/colitis 7. 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 PI or Co-PIs. 8. Participants who develop concurrent non-GI toxicity at the time of study treatment 9. Donors at risk for monkeypox infection and/ or exposure as determined by a questionnaire |
Country | Name | City | State |
---|---|---|---|
United States | M D Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Endoscopic remission (Mayo Clinic sub-score 0-1) of immune-related diarrhea/colitis | Endoscopic remission is defined as Mayo Clinic endoscopic subscore 0 or 1 (absence of ulcers, with or without mild erythema, friability and decreased vascular pattern). | At 4 weeks and 8 weeks post-FMT | |
Other | Histological remission (resolution of active inflammation) of immune-related diarrhea/colitis | Histological remission is defined resolution of active inflammation on biopsy sample. | At 8 weeks post-FMT | |
Other | Recurrent immune-related diarrhea/colitis following FMT and immune checkpoint inhibitors (ICPI) resumption within 6 months of ICPI resumption | Recurrent immune-related diarrhea colitis events occurring post-FMT will be recorded throughout the follow-up period. | Up to 6 months after restarting ICPI | |
Other | Measure immunological measures (including levels of cytokines (IL-6, 17, TNF, etc.) in tissue/blood/stool samples | Blood, stool, and colon tissues will be collected from at each scheduled time point. Markers of interest for immunological and biological profiles include levels of cytokines (IL-6, 17, TNF, etc). Special attention will focus on Bacteroidetes, Akkermansia, and Blautia. | Up to 3 months | |
Other | Frequencies of immune cells (CD4/8 T cells, regulatory T cells [Treg], macrophages, etc.) in tissue/blood/stool samples | Blood, stool, and colon tissues will be collected from at each scheduled time point. Markers of interest for immunological and biological profiles include frequencies of immune cells (CD4/8 T cells, Treg, macrophages, etc). Special attention will focus on Bacteroidetes, Akkermansia, and Blautia. | Up to 3 months | |
Primary | Incidence of fecal microbiota transplantation (FMT)-related adverse events | Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5. All events are recorded with grade and attribution to FMT. | Up to 3 months post-FMT | |
Primary | Clinical response/remission of immune-related diarrhea/colitis | 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. | At 2 weeks post-FMT | |
Secondary | Recurrent immune-related diarrhea/colitis within 3 months post-FMT after initially achieving clinical remission/response | Recurrent immune-related diarrhea colitis events occurring post-FMT are recorded throughout the follow-up period. | Up to 3 months post-FMT |
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