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Fecal Microbiota Transplantation

Fecal Microbiota Transplantation for Skin Cancer

Phase 1 & 2

Recruiting

Led By Yinghong Wang

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Treatment with any ICPI agent

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

Must not have

Age younger than 18 years

Patients with active bacterial or fungal infection (Project 3)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the role of the gut microbiome in patients with melanoma or genitourinary cancer who are experiencing medication-induced gastrointestinal complications.

Who is the study for?

This trial is for adults with melanoma, non-small cell lung cancer, or genitourinary cancers who are experiencing gastrointestinal issues due to immune-checkpoint inhibitor drugs. They must not have an active GI infection and should have a life expectancy over 4 months. Pregnant women and those under 18 are excluded.

What is being tested?

The study is testing how the gut microbiome affects colitis caused by cancer treatments and if fecal transplants can improve symptoms. It involves analyzing stool, blood, tissue samples from patients, and comparing these with standard treatments like steroids or other immunosuppressants.

What are the potential side effects?

Potential side effects may include discomfort from sample collection procedures (like endoscopic procedures), reactions to fecal transplants such as bloating or abdominal pain, and risks associated with immunosuppressive medications used in treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been treated with immune checkpoint inhibitors.

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I have been diagnosed with melanoma, lung cancer, or a genitourinary cancer.

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I have had severe diarrhea or colitis from cancer treatment in the last 45 days.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

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I do not have an active bacterial or fungal infection.

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I have active inflammatory bowel disease or radiation-induced bowel inflammation.

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If 30% of early participants don't improve with the fecal transplant, the study will stop.

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I had surgery for a serious gut issue caused by cancer immunotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Difference in stool microbiome pattern

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

Secondary study objectives

Changes of ICPI-related symptoms

Changes of endoscopic and histologic features of ICPI-related colitis before and after fecal microbiota transplantation

Changes of quality of life (QoL)

+4 more

Side effects data

From 2020 Phase 1 & 2 trial • 50 Patients • NCT03106844

44%

Diarrhea

26%

Abdominal Pain

16%

Rectal Bleeding

12%

Constiption

10%

Fever

10%

Nausea

Fatigue

Vomiting

Heart Burn

Chills

Yeast Infection

Migraine

Anemia

IBD Flare

100%

80%

60%

40%

20%

Study treatment Arm

Treatment

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Supportive Care (standard of care, sample collection, FMT)Experimental Treatment8 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Infliximab

2017

Completed Phase 4

~3350

Fecal Microbiota Transplantation

2020

Completed Phase 2

~440