Fecal Microbiota Transplantation for Skin Cancer

Overseen By Krishna Rajalu, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: M.D. Anderson Cancer Center

Must be taking: Immunosuppressive agents

Disqualifiers: Under 18, Inflammatory bowel disease, Pregnancy, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

800 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how fecal microbiota transplantation (using healthy stool to improve gut health) can aid individuals with skin or genitourinary cancers who develop gut problems from cancer medication. These issues, such as diarrhea and colitis (inflammation of the colon), often occur when patients receive immune-checkpoint inhibitors, a type of cancer drug. The trial seeks to determine if enhancing the gut microbiome (the community of bacteria in the gut) can alleviate these side effects. Suitable candidates have melanoma or genitourinary cancer and experience frequent diarrhea or colitis due to their cancer treatment. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants may be on immunosuppressive agents like steroids, infliximab, vedolizumab, or ustekinumab during the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that fecal microbiota transplantation (FMT) has been tested in people with advanced melanoma, a type of skin cancer. Most studies find that FMT is generally safe and usable. Side effects are usually mild to moderate, such as stomach cramps or diarrhea. However, there is a risk of infection, and little is known about its long-term safety.

In some studies, FMT helped patients live longer, suggesting it might be a promising option. However, considering the potential risks is important. Always consult a doctor to understand the benefits and possible side effects before joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using Fecal Microbiota Transplantation (FMT) for skin cancer because it offers a novel approach by harnessing the gut microbiome. Unlike traditional treatments like chemotherapy and immunotherapy, which directly target cancer cells, FMT aims to improve the body's immune response by altering the gut bacteria. This could potentially enhance the effectiveness of existing therapies and provide a new avenue for patients who do not respond well to standard treatments. Additionally, FMT is less invasive and may have fewer side effects compared to conventional cancer therapies, making it a promising area of exploration.

What evidence suggests that fecal microbiota transplantation could be effective for medication-induced GI complications in skin cancer patients?

Research has shown that fecal microbiota transplantation (FMT), one of the treatments studied in this trial, can benefit cancer patients, especially when combined with other treatments. Studies have found that FMT can enhance the effectiveness of cancer drugs, leading to improved survival rates and fewer side effects. For instance, patients with advanced melanoma who received FMT had a 65% positive response rate. FMT has also been used when cancer treatments lose effectiveness. In some cases, taking FMT in capsule form proved more effective than other methods. These findings suggest that FMT may help manage digestive issues, such as colitis, caused by cancer treatments. ^{1 3 5 6 7}

Who Is on the Research Team?

Yinghong Wang

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion 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.

Exclusion Criteria

I am under 18 years old.

I can choose to leave the trial at any time.

I do not have an active bacterial or fungal infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Standard of Care and Sample Collection

Patients receive standard of care and undergo collection of stool and blood samples

Up to 1 year

Medical Treatment and Endoscopy

Patients receive prednisone, infliximab, or vedolizumab and undergo standard of care endoscopy 2 months after treatment

2 months

Fecal Microbiota Transplantation (FMT)

Patients undergo fecal microbiota transplant

Up to 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Fecal Microbiota Transplantation
• Infliximab
• Prednisone
• Vedolizumab

Trial Overview 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.

How Is the Trial Designed?

Group I: Supportive Care (standard of care, sample collection, FMT) Experimental Treatment 8 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.

Fecal Microbiota Transplantation is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Fecal Microbiota Transplantation for:

• Graft-versus-host disease (GVHD)
• Clostridioides difficile infection (CDI)

Approved in European Union as Fecal Microbiota Transplantation for:

• Graft-versus-host disease (GVHD)
• Clostridioides difficile infection (CDI)
• Other gastrointestinal disorders

Approved in Canada as Fecal Microbiota Transplantation for:

• Graft-versus-host disease (GVHD)
• Clostridioides difficile infection (CDI)

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Fecal microbiota transplant (FMT) from tumor-bearing mice significantly improved cognitive function and short-term memory in Alzheimer's disease (AD) mice, indicating a potential therapeutic role for gut microbiota in cognitive impairment.

The FMT not only reduced Aβ plaque burden in the brain but also altered the gut microbiome composition, reversing specific microbial imbalances associated with AD, suggesting a complex interaction between gut health and cognitive function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transfer of Tumor-Bearing Mice Intestinal Flora Can Ameliorate Cognition in Alzheimer's Disease Mice. Hang, Z., Cai, S., Lei, T., et al.[2022]

In a study of 27 patients with therapy-refractory ulcerative colitis, faecal microbiota transplantation (FMT) resulted in a 59% response rate and a 24% remission rate, indicating its potential effectiveness as a treatment.

The success of FMT was significantly influenced by the donor's microbiota composition, particularly higher bacterial richness and specific beneficial bacteria like Akkermansia muciniphila, suggesting that tailored donor selection could enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The taxonomic composition of the donor intestinal microbiota is a major factor influencing the efficacy of faecal microbiota transplantation in therapy refractory ulcerative colitis. Kump, P., Wurm, P., Gröchenig, HP., et al.[2022]

Fecal microbiota transplantation (FMT) is highly effective for treating Clostridium difficile infection (CDI), with a 90% resolution of diarrhea reported in 867 patients across 33 studies, and a 94% resolution after repeated FMT in a randomized controlled trial with 16 participants.

FMT shows promise in treating ulcerative colitis, with remission rates varying from 0% to 68% in 106 patients, while its efficacy in Crohn's disease, chronic constipation, pouchitis, and irritable bowel syndrome remains inconclusive due to limited data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplantation as novel therapy in gastroenterology: A systematic review. Rossen, NG., MacDonald, JK., de Vries, EM., et al.[2022]

Fecal microbiota transplantation (FMT) is an effective treatment for restoring healthy gut bacteria in patients with disrupted intestinal microbiota, particularly in conditions like Clostridium difficile infection.

The review emphasizes the importance of careful donor selection and proper processing and storage of fecal material to ensure the safety and efficacy of the transplantation procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Fecal microbiota transplantation: donor selection criteria, storage and preparation of biomaterials (review of current recommendations)]. Iakupova, AA., Abdulkhakov, SR., Safin, AG., et al.[2022]

Fecal microbiota transplantation (FMT) has a reported adverse event (AE) rate of 39.3%, primarily involving mild and self-limiting issues like abdominal pain and diarrhea, based on a meta-analysis of 9 high-quality studies involving 756 FMTs.

Serious adverse events (SAE) were relatively rare at 5.3%, with the most common being Clostridium difficile infection, indicating that while FMT is generally safe, monitoring and standardized reporting are essential for understanding its long-term safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of fecal microbiota transplantation: a meta-analysis of high-quality studies. Michailidis, L., Currier, AC., Le, M., et al.[2022]

Faecal microbiota transplantation (FMT) has shown effectiveness in inducing remission in active ulcerative colitis (UC), with a clinical remission rate of 28% in FMT patients compared to 9% in placebo groups based on a meta-analysis of randomized controlled trials involving 277 patients.

The study found no major short-term safety concerns associated with FMT, suggesting it is a safe option for patients with UC, although further research is needed to optimize treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review with meta-analysis: faecal microbiota transplantation for the induction of remission for active ulcerative colitis. Costello, SP., Soo, W., Bryant, RV., et al.[2022]

Fecal microbiota transplantation (FMT) is recommended for treating recurrent Clostridium difficile infections and has shown benefits for various gastrointestinal disorders, but safety data is still limited due to the rapid adoption of the technique without extensive long-term studies.

Capsulized FMT therapy offers a promising solution for long-term maintenance and reduces the need for invasive procedures, indicating a shift towards safer and more tolerable methods of delivering FMT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Current research progress and thinking of fecal microbiota transplantation for the treatment of gastrointestinal disorders]. Li, N., Tian, H.[2020]

Fecal microbiota transplantation (FMT) is a safe and effective treatment for recurrent Clostridioides difficile infections, highlighting its importance in clinical practice.

The selection of fecal microbiota donors is crucial for ensuring the safety of recipients, prompting the establishment of protocols and recommendations by a multidisciplinary group in Cataluña to minimize risks associated with the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recommendations for stool donor selection for fecal microbiota transplant. Consensus document endorsed by the Catalan Society of Digestology, Catalan Society of Infectious diseases and Clinical Microbiology and the GEMBIOTA group from Spanish Society of Infectious Diseases and Clinical Microbiology. Aira, A., Arajol, C., Casals-Pascual, C., et al.[2022]

Fecal microbiota transplantation (FMT) is a generally safe and well-tolerated procedure for treating recurrent Clostridioides difficile infections, even in high-risk patients, with most short-term risks being mild and related to delivery methods.

Recent concerns have emerged regarding serious adverse events linked to FMT products from stool banks that do not screen for multi-drug resistant organisms, highlighting the need for improved safety protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal Microbiota Transplantation: Is It Safe? Park, SY., Seo, GS.[2021]

In 2019, 31 FMT centers across 17 European countries performed a total of 1,874 fecal microbiota transplants, primarily for Clostridioides difficile infection (CDI), indicating that FMT is a common treatment for this condition.

Despite the high safety standards and adherence to guidelines observed in these centers, only about 10% of the estimated patients needing FMT for recurrent CDI in Europe received the treatment, highlighting a significant gap in coverage and the need for increased clinical awareness and activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of Faecal Microbiota Transplantation (FMT) in Europe: A Europe-wide survey. Baunwall, SMD., Terveer, EM., Dahlerup, JF., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10854771/

The Use of Fecal Microbiota Transplant in Overcoming and ... This manuscript aims to review the use of FMT in advanced melanoma that has demonstrated treatment resistance.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12359429/

Improved survival in advanced melanoma patients treated ... Combination therapy was safe, and the objective response rate (ORR) was 65%. We now report survival data based on over 3 years of follow-up.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0305737225001471

Fecal microbiota transplantation to enhance cancer ... This systematic review evaluates Fecal Microbiota Transplantation (FMT)'s impact on cancer treatment outcomes and treatment-related toxicity ...

4. nature.com nature.com/articles/s41591-023-02453-x

Fecal microbiota transplantation plus anti-PD-1 ... Our clinical efficacy data show superior outcomes to either nivolumab or pembrolizumab monotherapy outcomes ... Fecal microbiota transplant ...

5. bmcmedicine.biomedcentral.com bmcmedicine.biomedcentral.com/articles/10.1186/s12916-025-04183-y

Microbiota boost immunotherapy? A meta-analysis dives into ... As for FMT methods, oral fecal microbiota capsules appeared to be more effective (ORR: 49%) compared to endoscopic delivery (ORR: 34%) or ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1931312824002749

From poo to promise: Fecal microbiota transplants support ... FMT has twice demonstrated utility for treatment-resistant melanoma,; a third trial showed benefit in the treatment-naïve melanoma setting.

7. frontiersin.org frontiersin.org/journals/immunology/articles/10.3389/fimmu.2024.1439176/full

Safety and efficacy of fecal microbiota transplantation (FMT ... While FMT is highly effective, it has considerable drawbacks, including the risk of infections and the lack of extensive long-term safety data (69, 70).