NCT04038619 Fecal Microbiota Transplantation in Treating Immune-Checkpoint Inhibitor Induced-Diarrhea or Colitis in Genitourinary Cancer Patients
| NCT ID | NCT04038619 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Colitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2021-02-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2021-02-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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. Patient 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 and/ or imaging (e.g. CXR, CT CAP etc) confirms the absence of active infections (e.g. TB) within 60 days 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
Contact & Investigator
Yinghong Wang
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT04038619 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04038619 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04038619 currently recruiting?
Yes, NCT04038619 is actively recruiting participants. Contact the research team at ywang59@mdanderson.org for enrollment information.
Where is the NCT04038619 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT04038619 clinical trial?
NCT04038619 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Yinghong Wang at M.D. Anderson Cancer Center. The trial plans to enroll 40 participants.