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

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.

Conditions

• Clinical Stage 0 Cutaneous Melanoma AJCC v8
• Clinical Stage I Cutaneous Melanoma AJCC v8
• Clinical Stage IA Cutaneous Melanoma AJCC v8
• Clinical Stage IB Cutaneous Melanoma AJCC v8
• Clinical Stage II Cutaneous Melanoma AJCC v8
• Clinical Stage IIA Cutaneous Melanoma AJCC v8
• Clinical Stage IIB Cutaneous Melanoma AJCC v8
• Clinical Stage IIC Cutaneous Melanoma AJCC v8
• Clinical Stage III Cutaneous Melanoma AJCC v8
• Clinical Stage IV Cutaneous Melanoma AJCC v8
• Colitis
• Lung Non-Small Cell Carcinoma
• Malignant Genitourinary System Neoplasm
• Malignant Solid Neoplasm
• Pathologic Stage 0 Cutaneous Melanoma AJCC v8
• Pathologic Stage I Cutaneous Melanoma AJCC v8
• Pathologic Stage IA Cutaneous Melanoma AJCC v8
• Pathologic Stage IB Cutaneous Melanoma AJCC v8
• Pathologic Stage II Cutaneous Melanoma AJCC v8
• Pathologic Stage IIA Cutaneous Melanoma AJCC v8
• Pathologic Stage IIB Cutaneous Melanoma AJCC v8
• Pathologic Stage IIC Cutaneous Melanoma AJCC v8
• Pathologic Stage III Cutaneous Melanoma AJCC v8
• Pathologic Stage IIIA Cutaneous Melanoma AJCC v8
• Pathologic Stage IIIB Cutaneous Melanoma AJCC v8
• Pathologic Stage IIIC Cutaneous Melanoma AJCC v8
• Pathologic Stage IIID Cutaneous Melanoma AJCC v8
• Pathologic Stage IV Cutaneous Melanoma AJCC v8
• Stage 0 Lung Cancer AJCC v8
• Stage I Lung Cancer AJCC v8
• Stage IA1 Lung Cancer AJCC v8
• Stage IA2 Lung Cancer AJCC v8
• Stage IA3 Lung Cancer AJCC v8
• Stage IB Lung Cancer AJCC v8
• Stage II Lung Cancer AJCC v8
• Stage IIA Lung Cancer AJCC v8
• Stage IIB Lung Cancer AJCC v8
• Stage III Lung Cancer AJCC v8
• Stage IIIA Lung Cancer AJCC v8
• Stage IIIB Lung Cancer AJCC v8
• Stage IIIC Lung Cancer AJCC v8
• Stage IV Lung Cancer AJCC v8
• Stage IVA Lung Cancer AJCC v8
• Stage 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

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Yinghong Wang · M.D. Anderson Cancer Center

Study Design

Allocation

NA

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-02-21

Primary Completion

2026-10-31

Completion

2026-10-31

FDA Drug

Yes

Countries

• United States

Study Locations