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

ConditionsClinical 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
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of any stage melanoma, Non-Small Cell Lung Cancer or genitourinary (GU) malignancies (Project 1).

Diagnosis of any cancer type (Projects 2 and 3)

Treatment with any ICPI agent

Ability to understand and willingness to sign an informed consent form and rate surveys

Disqualifiers

Age younger than 18 years

History of inflammatory bowel disease, and/or radiation enteritis or colitis with active disease status at the time of study treatment initiation

Pregnant and breastfeeding women

Women of child-bearing potential who have positive urine or serum pregnancy test or refuse to do pregnancy test unless last menstrual cycle was > 1 year prior to consent and/ or clear documentation states that patient is peri- or post-menopausal or there was recent supporting objective evidence of 'no pregnancy' status (e.g. blood or imaging) within 30 days prior to date of study treatment

Trial design

Design model

Single group

Treatments tested in this trial

  • Best Practice

    Other intervention

    Receive standard of care

  • Biospecimen Collection

    Other intervention

    Undergo collection of stool, blood, and tissue samples

  • Endoscopic Procedure

    Procedure/Surgery

    Undergo endoscopy

  • Fecal Microbiota Transplantation

    Procedure/Surgery

    Undergo FMT

  • Infliximab

    Biological/Vaccine

    Given intravenously (IV)

  • Laboratory Biomarker Analysis

    Other intervention

    Ancillary studies

  • Prednisone

    Drug

    Given orally

  • Vedolizumab

    Biological/Vaccine

    Given IV

Treatment groups

800 Participants
are divided into 1 treatment group
Group A: Supportive Care (standard of care, sample collection, FMT)Experimental treatment 8 interventions

Trial outcomes

Primary outcomes

1

Difference in stool microbiome pattern

The primary endpoint is alpha diversity of bacteria species (measured using inverse Simpson index). It is a measure of diversity which takes into account the number of species present, as well as the relative abundance of each species. As species richness and evenness increase, so diversity increases.

Time frame
Up to 1 year
2

Incidence of adverse events (AE) of fecal microbiota transplantation (FMT) (Project 3)

Adverse events will be recorded by Common Terminology Criteria for Adverse Events version 5 as well as FMT-specific events. All events will be recorded with grade and attribution to FMT. Adverse events that are related to fecal microbiota transplantation will be summarized using frequency and percentage by AE grade, type and attributions.

Time frame
Up to 1 year

Secondary outcomes

1

Immune profile factors associated with onset of ICPI-related colitis in blood and colon tissue

Immunohistochemistry study for inflammatory markers will be performed on colon biopsies to measure the change in pattern after treatment. Blood and stool samples will be compared before and after immunosuppressive treatment longitudinally and also horizontally between quick response patients and slow/refractory patient.

Time frame
Up to 1 year
2

Genetic factors associated with onset of ICPI-related colitis in blood and colon tissue

Genomic bacterial DNA will be extracted from fecal samples, with the addition of a bead-beating lysis step. Genomic 16S ribosomal-RNA V4 variable region will be amplified and sequenced on the Illumina MiSeq platform to obtain the microbiome structure and composition.

Time frame
Up to 1 year
3

Endoscopic and histologic features of ICPI-related colitis before and after medical treatment

We will assess the resolution of the following endoscopic presentations of ICPI-related colitis including large, deep ulcerations, erosions, diffuse or patchy erythema, inflammatory exudate, loss of vascular pattern, aphthae, and edema after medical treatment. We will assess the resolution of the following histological features of acute colitis and lymphocytic colitis including neutrophilic infiltration, cryptitis, crypt abscess, eosinophilia, intraepithelial apoptosis, and increased intraepithelial lymphocytic infiltration after medical treatment.

Time frame
Baseline up to 1 year
4

Changes of ICPI-related symptoms

We will use MD Anderson Symptom Inventory (MDASI)-Colitis module to capture ICPI-related symptoms, which include 22 physical, psychological, and cognitive symptoms and colitis related symptoms. The ratings are on 0-10 numeric scales, ranging from "not present" to "as bad as you can imagine.

Time frame
Up to 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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