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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Difference in stool microbiome pattern
Incidence of adverse events (AE) of fecal microbiota transplantation (FMT) (Project 3)
Secondary outcome measures
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%
Vomiting
6%
Fatigue
4%
Heart Burn
4%
Chills
4%
Migraine
4%
Yeast Infection
2%
Anemia
2%
IBD Flare
100%
80%
60%
40%
20%
0%
Study treatment Arm
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
~3280
Prednisone
2014
Completed Phase 4
~2370
Fecal Microbiota Transplantation
2016
Completed Phase 2
~350
Vedolizumab
2009
Completed Phase 4
~10330
Endoscopic Procedure
2015
N/A
~250
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,977 Previous Clinical Trials
1,788,738 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,692 Previous Clinical Trials
40,929,206 Total Patients Enrolled
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there documented precedents of Fecal Microbiota Transplantation experiments?
"Currently, 462 Fecal Microbiota Transplantation studies are underway with 127 in Phase 3. Of these trials, 18330 sites have been set up for patient recruitment; Duarte, California is one such example."
Answered by AI
How many participants are involved in the ongoing trial?
"Affirmative. Clinicaltrials.gov data shows that this clinical trial, initially posted on February 21 2021, is currently recruiting patients. 800 test subjects are required from a single medical site."
Answered by AI
Is enrollment currently open for the participants of this experiment?
"Affirmative. The data available on clinicaltrials.gov evidences that this study, initially posted on February 21st 2021, is still recruiting participants. 800 individuals need to be enrolled from a single medical centre."
Answered by AI
What is the ultimate purpose of this research project?
"The primary focus of this year-long trial is to monitor changes in stool microbiome patterns. Secondary objectives include exploring the impact of genetic factors on ICPI-related colitis and measuring endoscopic, histologic, and symptomological improvements after fecal microbiota transplantation (FMT). To achieve these goals, techniques such as genomic bacterial DNA extraction from fecal samples using bead-beating lysis; Illumina MiSeq amplifications and sequencing for assessing microbiome structure/composition; MD Anderson Symptom Inventory Colitis Module assessments are being used."
Answered by AI
To what kind of ailments is Fecal Microbiota Transplantation typically administered?
"Fecal Microbiota Transplantation is a viable medical solution for scalp structure, thyroiditis and psoriasis."
Answered by AI
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