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RecruitingPhase 1NCT03819296

Role of Gut Microbiome and Fecal Transplant on Medication-Induced GI Complications in Patients With Cancer

Role of Microbiome in the Realm of Immune-Checkpoint Inhibitor Induced GI Complications In Cancer Population

Sponsor

M.D. Anderson Cancer Center

Enrollment

800 participants

Start Date

Feb 21, 2021

Study Type

INTERVENTIONAL

Conditions

Malignant Solid NeoplasmClinical Stage III Cutaneous Melanoma AJCC v8Clinical Stage IV Cutaneous Melanoma AJCC v8Stage III Lung Cancer AJCC v8Stage IIIA Lung Cancer AJCC v8Stage IIIB Lung Cancer AJCC v8Stage IIIC Lung Cancer AJCC v8Stage IV Lung Cancer AJCC v8Stage IVA Lung Cancer AJCC v8Stage IVB Lung Cancer AJCC v8Clinical Stage I Cutaneous Melanoma AJCC v8Clinical Stage IA Cutaneous Melanoma AJCC v8Clinical Stage IB Cutaneous Melanoma AJCC v8Clinical Stage II Cutaneous Melanoma AJCC v8Clinical Stage IIA Cutaneous Melanoma AJCC v8Clinical Stage IIB Cutaneous Melanoma AJCC v8Clinical Stage IIC Cutaneous Melanoma AJCC v8Pathologic Stage I Cutaneous Melanoma AJCC v8Pathologic Stage IA Cutaneous Melanoma AJCC v8Pathologic Stage IB Cutaneous Melanoma AJCC v8Pathologic Stage II Cutaneous Melanoma AJCC v8Pathologic Stage IIA Cutaneous Melanoma AJCC v8Pathologic Stage IIB Cutaneous Melanoma AJCC v8Pathologic Stage IIC Cutaneous Melanoma AJCC v8Pathologic Stage III Cutaneous Melanoma AJCC v8Pathologic Stage IIIA Cutaneous Melanoma AJCC v8Pathologic Stage IIIB Cutaneous Melanoma AJCC v8Pathologic Stage IIIC Cutaneous Melanoma AJCC v8Pathologic Stage IIID Cutaneous Melanoma AJCC v8Pathologic Stage IV Cutaneous Melanoma AJCC v8ColitisMalignant Genitourinary System NeoplasmLung Non-Small Cell CarcinomaStage II Lung Cancer AJCC v8Stage IIB Lung Cancer AJCC v8Stage I Lung Cancer AJCC v8Stage IA2 Lung Cancer AJCC v8Stage IA3 Lung Cancer AJCC v8Stage IA1 Lung Cancer AJCC v8Stage IB Lung Cancer AJCC v8Stage IIA Lung Cancer AJCC v8Clinical Stage 0 Cutaneous Melanoma AJCC v8Pathologic Stage 0 Cutaneous Melanoma AJCC v8Stage 0 Lung Cancer AJCC v8

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating how gut bacteria (the microbiome) affect diarrhea and colon inflammation that some cancer patients experience as a side effect of immunotherapy drugs (called immune checkpoint inhibitors, or ICPIs — drugs that boost the immune system to fight cancer). **You may be eligible if...** - You have been diagnosed with melanoma, non-small cell lung cancer, or genitourinary cancers (like bladder or kidney cancer), OR any cancer type depending on the study project - You are receiving or have received an immunotherapy (immune checkpoint inhibitor) drug - You are willing and able to give consent and complete surveys **You may NOT be eligible if...** - You are not receiving immunotherapy treatment - Your life expectancy is less than 4 months (for certain project components) - You are unable to give informed consent or complete required surveys Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

Given orally

BIOLOGICALVedolizumab

Given IV

Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT03819296

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