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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 belowSelect...
I have been treated with immune checkpoint inhibitors.
Select...
I have been diagnosed with melanoma, lung cancer, or a genitourinary cancer.
Select...
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:Select...
I am under 18 years old.
Select...
I do not have an active bacterial or fungal infection.
Select...
I have active inflammatory bowel disease or radiation-induced bowel inflammation.
Select...
If 30% of early participants don't improve with the fecal transplant, the study will stop.
Select...
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
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 moreSide effects data
From 2020 Phase 1 & 2 trial • 50 Patients • NCT0310684444%
Diarrhea
26%
Abdominal Pain
16%
Rectal Bleeding
12%
Constiption
10%
Fever
10%
Nausea
6%
Fatigue
6%
Vomiting
4%
Heart Burn
4%
Chills
4%
Yeast Infection
4%
Migraine
2%
Anemia
2%
IBD Flare
100%
80%
60%
40%
20%
0%
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
Prednisone
2014
Completed Phase 4
~2500
Vedolizumab
2009
Completed Phase 4
~10220
Endoscopic Procedure
2015
N/A
~250
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,074 Previous Clinical Trials
1,802,547 Total Patients Enrolled
2 Trials studying Cutaneous Melanoma
5,053 Patients Enrolled for Cutaneous Melanoma
National Cancer Institute (NCI)NIH
13,957 Previous Clinical Trials
41,111,237 Total Patients Enrolled
5 Trials studying Cutaneous Melanoma
146 Patients Enrolled for Cutaneous Melanoma
Yinghong WangPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
140 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with immune checkpoint inhibitors.I have been diagnosed with melanoma, lung cancer, or a genitourinary cancer.I have had severe colitis or diarrhea from cancer treatment that hasn't improved with standard treatments.I am under 18 years old.I don't have an active GI infection as confirmed by tests or my doctor.I can choose to leave the trial at any time.I do not have an active bacterial or fungal infection.I experienced side effects outside my digestive system during my FMT treatment.I have active inflammatory bowel disease or radiation-induced bowel inflammation.You are expected to live for at least 4 more months.You have been exposed to monkeypox or are at risk of getting infected, as determined by a questionnaire.I do not have any organ damage.I am not pregnant or have confirmed I'm not pregnant through tests if capable of becoming pregnant.I have been diagnosed with cancer.If 30% of early participants don't improve with the fecal transplant, the study will stop.I have experienced diarrhea or colitis from immune checkpoint inhibitor therapy.I have had severe diarrhea or colitis from cancer treatment in the last 45 days.I have had severe colitis or diarrhea from cancer treatment and received specific treatments for it.I had surgery for a serious gut issue caused by cancer immunotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: Supportive Care (standard of care, sample collection, FMT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.