Health Trials

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

ConditionsClinical 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
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

Qualifiers

Diagnosis of any stage melanoma, Non-Small Cell Lung Cancer or genitourinary (GU) malignancies (Project 1).

Diagnosis of any cancer type (Projects 2 and 3)

Treatment with any ICPI agent

Ability to understand and willingness to sign an informed consent form and rate surveys

Disqualifiers

Age younger than 18 years

History of inflammatory bowel disease, and/or radiation enteritis or colitis with active disease status at the time of study treatment initiation

Pregnant and breastfeeding women

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

Trial design

Treatments tested in this trial

  • Best Practice
  • Biospecimen Collection
  • Endoscopic Procedure
  • Fecal Microbiota Transplantation
  • Infliximab
  • Laboratory Biomarker Analysis
  • Prednisone
  • Vedolizumab

Treatment groups

800 Participants
are divided into 1 treatment group

Locations

1
M D Anderson Cancer Center77030, HoustonTexas, United States

Sponsors and collaborators

M.D. Anderson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov