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

  • STATUS
    Recruiting
  • End date
    Jan 30, 2023
  • participants needed
    800
  • sponsor
    M.D. Anderson Cancer Center
Updated on 11 April 2021

Summary

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.

Description

PRIMARY OBJECTIVES:

I. To compare the difference in stool microbiome pattern between patients who develop immune-checkpoint inhibitor (ICPI)-related colitis and patients who don't develop ICPI-related colitis.

II. To compare the difference in stool microbiome pattern in patients who developed ICPI-related colitis before and after colitis medical treatment.

III. To assess the safety and tolerability and efficacy of fecal microbiota transplantation (FMT).

SECONDARY OBJECTIVES:

I. To identify and characterize immune profile and genetic factors associated with onset of ICPI-related colitis in blood and colon tissue.

II. To identify and characterize immune profile and genetic factors in blood and colon tissue that are associated with quick response of ICPI-related colitis to medical treatment.

III. To characterize the endoscopic and histologic features of ICPI-related colitis before and after medical treatment.

IV. To document the changes of ICPI-related symptoms and the impact on functioning and quality of life (QoL) from fecal microbiota transplantation by patient-reported outcomes (PRO).

V. To assess stool microbiome and cytokine features that are associated with good response to fecal microbiota transplantation.

VI. To assess the factors in genetic/immune profile obtained from blood and colon tissue that are associated with good response to fecal microbiota transplantation.

VII. To characterize the endoscopic and histologic features of ICPI-related colitis before and after fecal microbiota transplantation.

EXPLORATORY OBJECTIVES:

I. To identify and characterize immune profile and genetic factors associated with onset of ICPI-related colitis in inflamed colonic mucosa and its matched normal mucosa.

II. To characterize the immune profile and genetic factors from the colon tissue in these colitis patients among different histological subtypes.

III. To assess the pattern of stool microbiome that is associated with good tumor response to ICPI treatment.

IV. To assess the association between stool inflammatory markers (i.e. lactoferrin and calprotectin) and the severity of endoscopic/histologic inflammation.

V. To assess the sensitivity and specificity of stool inflammatory markers (i.e. lactoferrin and calprotectin) as an indicators of ICPI-relate colitis response to treatment.

VI. To assess the microbiome pattern that triggers the infections on immunosuppressant treatment for ICPI colitis.

OUTLINE

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 fecal microbiota transplant (FMT).

After completion of study, patients are followed up periodically.

Details
Condition Gastroenteritis, Gastroenteritis, Colitis, Infectious Colitis, Infectious Colitis, Malignant Solid Tumor, Malignant Solid Neoplasm, Clinical Stage III Cutaneous Melanoma AJCC v8, Pathologic Stage III Cutaneous Melanoma AJCC v8, Pathologic Stage IIIA Cutaneous Melanoma AJCC v8, Pathologic Stage IIIB Cutaneous Melanoma AJCC v8, Pathologic Stage IIIC Cutaneous Melanoma AJCC v8, Pathologic Stage IIID Cutaneous Melanoma AJCC v8, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8, Stage III Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8, Stage IIIC Lung Cancer AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Pathologic Stage IV Cutaneous Melanoma AJCC v8, Stage I Lung Cancer AJCC v8, Stage IA1 Lung Cancer AJCC v8, Stage IA2 Lung Cancer AJCC v8, Stage IA3 Lung Cancer AJCC v8, Stage IB Lung Cancer AJCC v8, Stage II Lung Cancer AJCC v8, Stage IIA Lung Cancer AJCC v8, Stage IIB Lung Cancer AJCC v8, Genitourinary Cancer, Stage 0 Lung Cancer AJCC v8, Clinical Stage 0 Cutaneous Melanoma AJCC v8, Clinical Stage I Cutaneous Melanoma AJCC v8, Clinical Stage IA Cutaneous Melanoma AJCC v8, Clinical Stage IB Cutaneous Melanoma AJCC v8, Clinical Stage II Cutaneous Melanoma AJCC v8, Clinical Stage IIA Cutaneous Melanoma AJCC v8, Clinical Stage IIB Cutaneous Melanoma AJCC v8, Clinical Stage IIC Cutaneous Melanoma AJCC v8, Pathologic Stage 0 Cutaneous Melanoma AJCC v8, Pathologic Stage I Cutaneous Melanoma AJCC v8, Pathologic Stage IA Cutaneous Melanoma AJCC v8, Pathologic Stage IB Cutaneous Melanoma AJCC v8, Pathologic Stage II Cutaneous Melanoma AJCC v8, Pathologic Stage IIA Cutaneous Melanoma AJCC v8, Pathologic Stage IIB Cutaneous Melanoma AJCC v8, Pathologic Stage IIC Cutaneous Melanoma AJCC v8, Malignant Genitourinary System Neoplasm, Lung Non-Small Cell Carcinoma, Lung Non-Small Cell Carcinoma, Lung Non-Small Cell Carcinoma, Lung Non-Small Cell Carcinoma
Treatment laboratory biomarker analysis, prednisone, endoscopic procedure, Infliximab, Fecal Microbiota Transplantation, biospecimen collection, Vedolizumab, Best Practice
Clinical Study IdentifierNCT03819296
SponsorM.D. Anderson Cancer Center
Last Modified on11 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

PROJECT 1 AND 2: Diagnosis of any stage melanoma, non-small cell lung cancer or genitourinary (GU) malignancies
PROJECT 3: Diagnosis of any cancer type
Treatment with any ICPI agent
Ability to understand and willingness to sign an informed consent form and rate on surveys
Life expectancy > 4 months
PROJECT 1: ICPI-related diarrhea/colitis of any grade with or without concurrent non GI toxicity as the toxicity group
PROJECT 1: Patients with no organ toxicity as the control group
PROJECTS 2 AND 3: ICPI-related colitis of grade 2 or above as GI toxicity without involvement of non GI toxicity
PROJECT 3: ICPI-related colitis with ANY of the following characteristics: (1) refractory to treatment of steroid and two doses of non-steroidal immunosuppressants e.g. infliximab and/or vedolizumab; (2) contraindication for immunosuppressive treatment; or (3) recurrence after successful initial treatment

Exclusion Criteria

Positive GI infection at the onset of ICPI-related GI toxicity
History of inflammatory bowel disease, and/or radiation enteritis or colitis
Pregnant and breastfeeding women
Women of child-bearing potential who have positive urine or serum pregnancy test or refuse to do pregnancy test
PROJECT 2: Patients who have a contraindication for immunosuppressive treatment
PROJECT 2: Patients who develop concurrent or only non GI toxicity
PROJECT 3: Patients with active bacterial or fungal infection
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note