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

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Best Practice — OTHER
  Receive standard of care
• Biospecimen Collection — OTHER
  Undergo collection of stool, blood, and tissue samples
• Endoscopic Procedure — PROCEDURE
  Undergo endoscopy
• Fecal Microbiota Transplantation — PROCEDURE
  Undergo FMT
• Infliximab — BIOLOGICAL
  Given intravenously (IV)
• Laboratory Biomarker Analysis — OTHER
  Ancillary studies
• Prednisone — DRUG
  Given orally
• Vedolizumab — BIOLOGICAL
  Given IV

Study Details

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.

Key Dates

Start date

Feb 21, 2021

Status verified

Mar 2026

Primary completion

Oct 31, 2026

Completion

Oct 31, 2026

Study Design

Enrollment

800 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: Supportive Care (standard of care, sample collection, FMT)
  PROJECT 1: Patients receive standard of care and undergo collection of stool and blood samples. PROJECT 2: Patients receive prednisone, infliximab, or vedolizumab per standard of care and undergo standard of care endoscopy 2 months after treatment. Patients also undergo collection of stool, blood, and tissue samples. PROJECT 3: Patients undergo FMT.

Primary Outcome Measure

Difference in stool microbiome pattern [ Time Frame: Up to 1 year ]

Central Contacts

• Krishna Rajalu, MD
  713-563-6086
  [email protected]

Locations (1)

Find similar trials in Houston, TX

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