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

• Status: Recruiting
• Trial end date: 2023-01-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cortisone; Cortisone acetate; Immunoglobulin G; Immunoglobulins; Infliximab; Prednisone; Vedolizumab

Criteria

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.