Exploring gut microbiome and fecal transplant effects on GI issues in cancer patients
Role of Microbiome in the Realm of Immune-Checkpoint Inhibitor Induced GI Complications In Cancer Population
This study is testing how the gut bacteria affect stomach issues in cancer patients receiving certain treatments and whether a stool transplant can help relieve those problems.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | infliximab, vedolizumab, ustekinumab, radiation, prednisone |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT03819296 on ClinicalTrials.gov |
What this trial studies
This trial investigates how the gut microbiome influences gastrointestinal complications caused by immune-checkpoint inhibitor (ICPI) treatments in patients with melanoma and genitourinary cancers. It aims to compare microbiome patterns between patients who develop colitis and those who do not, as well as assess the safety and efficacy of fecal microbiota transplantation (FMT) for alleviating these symptoms. The study will also analyze immune profiles and genetic factors related to colitis onset and response to treatment, utilizing stool, blood, and tissue samples for comprehensive evaluation.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with any stage melanoma or genitourinary cancer who are experiencing ICPI-related gastrointestinal issues.
Not a fit: Patients with cancers not treated with immune-checkpoint inhibitors or those without gastrointestinal complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of GI complications in cancer patients undergoing ICPI treatment.
How similar studies have performed: While the role of the gut microbiome in cancer treatment is being explored, this specific approach combining fecal transplantation with ICPI-related complications is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Diagnosis of any stage melanoma, Non-Small Cell Lung Cancer or genitourinary (GU) malignancies (Project 1).
2. Diagnosis of any cancer type (Projects 2 and 3)
3. Treatment with any ICPI agent
4. Ability to understand and willingness to sign an informed consent form and rate surveys
5. Life expectancy \> 4 months (Project 3)
6. ICPI-related diarrhea and/or colitis of any grade with or without concurrent non- GI toxicity as the toxicity group (project 1)
7. Patients with no organ toxicity as the control group (project 1)
8. ICPI-related colitis and/or diarrhea of grade ≥ 2 as GI toxicity (initial episode or recurrence) receiving standard treatment of immunosuppressive agents (steroid, infliximab, vedolizumab, or ustekinumab) any time during the colitis disease course until sustained resolution of GI toxicity, or one- year time point after enrollment (Project 2)
9. ICPI-related colitis and/or diarrhea of grade ≥ 2 as GI toxicity without involvement of non- GI toxicity within 45 days prior to FMT (Project 3)
10. ICPI-related colitis and/or diarrhea of grade ≥ 2 within 45 days prior to FMT with ANY of the following characteristics (project 3):
(i) refractory to treatment of steroid and two doses of non-steroidal immunosuppressants e.g. infliximab, vedolizumab or ustekinumab,
(ii) contraindication for immunosuppressive treatment,
(iii) recurrence after successful initial treatment,
(iv) recurrent symptoms once steroid is tapered down/off or diarrhea/colitis symptoms are steroid dependent, or
(v) patients with a history of refractory ICPI-related colitis and/or diarrhea to medical treatment, even if they have improved symptoms from supportive care within 45 days prior to FMT
11. No concern for active concomitant GI infection for the ICPI diarrhea/colitis work up at the time of protocol therapy initiation as confirmed by stool tests or as per the treating physician based on clinical presentation (project 3)
12. Patient who 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 diarrhea/colitis treatment (project 3)
Exclusion Criteria:
1. Age younger than 18 years
2. History of inflammatory bowel disease, and/or radiation enteritis or colitis with active disease status at the time of study treatment initiation
3. Pregnant and breastfeeding women
4. Women of child-bearing potential 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 patient is peri- or post-menopausal or there was recent supporting objective evidence of 'no pregnancy' status (e.g. blood or imaging) within 30 days prior to date of study treatment
5. Patients who develop concurrent non- GI toxicity at the time of FMT treatment (project 3)
6. Patients with active bacterial or fungal infection (Project 3)
7. Donors at risk for monkeypox infection and/ or exposure as determined by a questionnaire (Project 3)
Withdrawal Criteria
1. Patients may withdraw from the trial at any time
2. Patients who develop GI perforation or toxic colitis that require surgery from ICPI colitis
3. In project 3, if the first 30% of cases fail the fecal transplant treatment, then project 3 will be terminated
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Yinghong Wang — M.D. Anderson Cancer Center
- Study coordinator: Krishna Rajalu, MD
- Email: kvaratharajalu@mdanderson.org
- Phone: 713-563-6086
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.