RECRUITING

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

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Conditions

Clinical Stage 0 Cutaneous Melanoma AJCC v8Clinical Stage I Cutaneous Melanoma AJCC v8Clinical Stage IA Cutaneous Melanoma AJCC v8Clinical Stage IB Cutaneous Melanoma AJCC v8Clinical Stage II Cutaneous Melanoma AJCC v8Clinical Stage IIA Cutaneous Melanoma AJCC v8Clinical Stage IIB Cutaneous Melanoma AJCC v8Clinical Stage IIC Cutaneous Melanoma AJCC v8Clinical Stage III Cutaneous Melanoma AJCC v8Clinical Stage IV Cutaneous Melanoma AJCC v8ColitisLung Non-Small Cell CarcinomaMalignant Genitourinary System NeoplasmMalignant Solid NeoplasmPathologic Stage 0 Cutaneous Melanoma AJCC v8Pathologic Stage I Cutaneous Melanoma AJCC v8Pathologic Stage IA Cutaneous Melanoma AJCC v8Pathologic Stage IB Cutaneous Melanoma AJCC v8Pathologic Stage II Cutaneous Melanoma AJCC v8Pathologic Stage IIA Cutaneous Melanoma AJCC v8Pathologic Stage IIB Cutaneous Melanoma AJCC v8Pathologic Stage IIC Cutaneous Melanoma AJCC v8Pathologic Stage III Cutaneous Melanoma AJCC v8Pathologic Stage IIIA Cutaneous Melanoma AJCC v8Pathologic Stage IIIB Cutaneous Melanoma AJCC v8Pathologic Stage IIIC Cutaneous Melanoma AJCC v8Pathologic Stage IIID Cutaneous Melanoma AJCC v8Pathologic Stage IV Cutaneous Melanoma AJCC v8Stage 0 Lung Cancer AJCC v8Stage I Lung Cancer AJCC v8Stage IA1 Lung Cancer AJCC v8Stage IA2 Lung Cancer AJCC v8Stage IA3 Lung Cancer AJCC v8Stage IB Lung Cancer AJCC v8Stage II Lung Cancer AJCC v8Stage IIA Lung Cancer AJCC v8Stage IIB Lung Cancer AJCC v8Stage III Lung Cancer AJCC v8Stage IIIA Lung Cancer AJCC v8Stage IIIB Lung Cancer AJCC v8Stage IIIC Lung Cancer AJCC v8Stage IV Lung Cancer AJCC v8Stage IVA Lung Cancer AJCC v8Stage IVB Lung Cancer AJCC v8

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Role of Microbiome in the Realm of Immune-Checkpoint Inhibitor Induced GI Complications In Cancer Population

Quick Facts

Study Start:2021-02-21
Study Completion:2025-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03819296

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Diagnosis of any stage melanoma, Non-Small Cell Lung Cancer or genitourinary (GU) malignancies (Project 1).
  2. 2. Diagnosis of any cancer type (Projects 2 and 3)
  3. 3. Treatment with any ICPI agent
  4. 4. Ability to understand and willingness to sign an informed consent form and rate surveys
  5. 5. Life expectancy \> 4 months (Project 3)
  6. 6. ICPI-related diarrhea and/or colitis of any grade with or without concurrent non- GI toxicity as the toxicity group (project 1)
  7. 7. Patients with no organ toxicity as the control group (project 1)
  8. 8. ICPI-related colitis and/or diarrhea of grade ≥ 2 as GI toxicity (initial episode or recurrence) receiving standard treatment of immunosuppressive agents (steroid, infliximab, vedolizumab, or ustekinumab) any time during the colitis disease course until sustained resolution of GI toxicity, or one- year time point after enrollment (Project 2)
  9. 9. ICPI-related colitis and/or diarrhea of grade ≥ 2 as GI toxicity without involvement of non- GI toxicity within 45 days prior to FMT (Project 3)
  10. 10. ICPI-related colitis and/or diarrhea of grade ≥ 2 within 45 days prior to FMT with ANY of the following characteristics (project 3):
  11. 11. No concern for active concomitant GI infection for the ICPI diarrhea/colitis work up at the time of protocol therapy initiation as confirmed by stool tests or as per the treating physician based on clinical presentation (project 3)
  12. 12. Patient who has been cleared for enrollment by Infectious Diseases consultant or treating physician if positive infection workup or screening tests (e.g. lifelong positive T-spot due to BCG inoculation, chronic colonization) prior to initiation of diarrhea/colitis treatment (project 3)
  1. 1. Age younger than 18 years
  2. 2. History of inflammatory bowel disease, and/or radiation enteritis or colitis with active disease status at the time of study treatment initiation
  3. 3. Pregnant and breastfeeding women
  4. 4. Women of child-bearing potential who have positive urine or serum pregnancy test or refuse to do pregnancy test unless last menstrual cycle was \> 1 year prior to consent and/ or clear documentation states that patient is peri- or post-menopausal or there was recent supporting objective evidence of 'no pregnancy' status (e.g. blood or imaging) within 30 days prior to date of study treatment
  5. 5. Patients who develop concurrent non- GI toxicity at the time of FMT treatment (project 3)
  6. 6. Patients with active bacterial or fungal infection (Project 3)
  7. 7. Donors at risk for monkeypox infection and/ or exposure as determined by a questionnaire (Project 3)
  8. 1. Patients may withdraw from the trial at any time
  9. 2. Patients who develop GI perforation or toxic colitis that require surgery from ICPI colitis
  10. 3. In project 3, if the first 30% of cases fail the fecal transplant treatment, then project 3 will be terminated

Contacts and Locations

Study Contact

Krishna Rajalu, MD
CONTACT
713-563-6086
kvaratharajalu@mdanderson.org

Principal Investigator

Yinghong Wang
PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

  • Yinghong Wang, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-02-21
Study Completion Date2025-10-31

Study Record Updates

Study Start Date2021-02-21
Study Completion Date2025-10-31

Terms related to this study

Additional Relevant MeSH Terms

  • 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
  • Clinical Stage III Cutaneous Melanoma AJCC v8
  • Clinical Stage IV Cutaneous Melanoma AJCC v8
  • Colitis
  • Lung Non-Small Cell Carcinoma
  • Malignant Genitourinary System Neoplasm
  • Malignant Solid Neoplasm
  • 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
  • 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
  • Pathologic Stage IV Cutaneous Melanoma AJCC v8
  • Stage 0 Lung Cancer 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
  • Stage III Lung Cancer AJCC v8
  • Stage IIIA Lung Cancer AJCC v8
  • Stage IIIB Lung Cancer AJCC v8
  • Stage IIIC Lung Cancer AJCC v8
  • Stage IV Lung Cancer AJCC v8
  • Stage IVA Lung Cancer AJCC v8
  • Stage IVB Lung Cancer AJCC v8