Role of Microbiome in the Realm of Immune-Checkpoint Inhibitor Induced GI Complications In Cancer Population
M.D. Anderson Cancer Center
Summary
This trial studies the role of the gut microbiome and effectiveness of a fecal transplant on medication-induced gastrointestinal (GI) complications in patients with melanoma or genitourinary cancer. The gut microbiome (the bacteria and microorganisms that live in the digestive system) may affect whether or not someone develops colitis (inflammation of the intestines) during cancer treatment with immune-checkpoint inhibitor drugs. Studying samples of stool, blood, and tissue from patients with melanoma or genitourinary cancer may help doctors learn more about the effects of treatment on cells, and help doctors understand how well patients respond to treatment. Treatment with fecal transplantation may help to improve diarrhea and colitis symptoms.
Description
PRIMARY OBJECTIVES: I. To compare the difference in stool microbiome pattern between patients who develop immune-checkpoint inhibitor (ICPI)-related colitis and patients who don't develop ICPI-related colitis. II. To compare the difference in stool microbiome pattern in patients who developed ICPI-related colitis before and after colitis medical treatment. III. To assess the safety and tolerability and efficacy of fecal microbiota transplantation (FMT). SECONDARY OBJECTIVES: I. To identify and characterize immune profile and genetic factors associated with onset of ICPI-related colitis in…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 ≥…
Interventions
- OtherBest Practice
Receive standard of care
- OtherBiospecimen Collection
Undergo collection of stool, blood, and tissue samples
- ProcedureEndoscopic Procedure
Undergo endoscopy
- ProcedureFecal Microbiota Transplantation
Undergo FMT
- BiologicalInfliximab
Given intravenously (IV)
- OtherLaboratory Biomarker Analysis
Ancillary studies
- DrugPrednisone
Location
- M D Anderson Cancer CenterHouston, Texas