NCT03819296 - Role of Gut Microbiome and Fecal Transplant on Medication-Induced GI Complications in Patients With Cancer | Biotech Hunter

Enrollment

800

Participants

Timeline

Start Date

February 21, 2021

Primary Completion Date

October 31, 2025

Study Completion Date

October 31, 2025

Conditions

Clinical Stage 0 Cutaneous Melanoma 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 v8Clinical Stage III Cutaneous Melanoma AJCC v8Clinical Stage IV Cutaneous Melanoma AJCC v8ColitisLung Non-Small Cell CarcinomaMalignant Genitourinary System NeoplasmMalignant Solid NeoplasmPathologic Stage 0 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 v8Stage 0 Lung Cancer AJCC v8Stage I Lung Cancer AJCC v8Stage IA1 Lung Cancer AJCC v8Stage IA2 Lung Cancer AJCC v8Stage IA3 Lung Cancer AJCC v8Stage IB Lung Cancer AJCC v8Stage II Lung Cancer AJCC v8Stage IIA Lung Cancer AJCC v8Stage IIB Lung Cancer 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 v8

Interventions

OTHER

Best Practice

Receive standard of care

OTHER

Biospecimen Collection

Undergo collection of stool, blood, and tissue samples

PROCEDURE

Endoscopic Procedure

Undergo endoscopy

PROCEDURE

Fecal Microbiota Transplantation

Undergo FMT

BIOLOGICAL

Infliximab

Given intravenously (IV)

OTHER

Laboratory Biomarker Analysis

Ancillary studies

DRUG

Prednisone

Given orally

BIOLOGICAL

Vedolizumab

Given IV

Trial Locations (1)

77030

RECRUITING

M D Anderson Cancer Center, Houston

All Listed Sponsors

collaborator

National Cancer Institute (NCI)

NIH

lead

M.D. Anderson Cancer Center

OTHER