Ustekinumab for Diarrhea and Colitis in Cancer Patients

Recruiting in Palo Alto (17 mi)

Overseen byYinghong Wang, MD,PHD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?The goal of this clinical research study is to learn if ustekinumab can help to control immune-related diarrhea and/or colitis in cancer patients.

Eligibility Criteria

This trial is for adult cancer patients with immune-related diarrhea or colitis from checkpoint inhibitor therapy. They must not have GI infections, inflammatory bowel disease, or be on other immunosuppressives. Pregnant women and those under 18 are excluded.

Inclusion Criteria

No concern for active concomitant GI infection for immune-related diarrhea and/or 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

I am receiving immunotherapy.

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

+4 more

Exclusion Criteria

I am under 18 years old.

Pregnant and breastfeeding women

I am experiencing side effects not related to my digestive system from my current treatment.

+5 more

Participant Groups

The study tests if ustekinumab can control immune-related diarrhea/colitis in cancer patients who've had grade 2 or higher symptoms within the last 45 days after receiving any type of ICI therapy.

1Treatment groups

Experimental Treatment

Group I: Single ArmExperimental Treatment1 Intervention

Participants will be identified per the evaluation of primary oncology and/or gastroenterology consult services.