Checkpoint Inhibitor Associated Diabetes Mellitus: Early Recognition and Treatment (CERT) Project: A Pilot Study
M.D. Anderson Cancer Center
Summary
To find out if taking a drug called infliximab (the "study drug") is safe and effective in reversing insulin dependence in CIADM.
Description
Primary Objective 1\. To estimate the efficacy of infliximab in reversing insulin dependence in CIADM. Secondary Objective 1. To evaluate the safety of infliximab when used for CIADM. 2. To estimate the duration of time off insulin for patients who are able to discontinue insulin.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Eligibility Criteria * Participants on ICI referred to endocrine for new diagnosis of CIADM, will be included provided they are within 12 months of last dose of ICI and if they have: * New onset diabetes≥ 200 mg/dl and/or A1c ≥6.5 OR * Worsening glycemic control: requiring insulin per clinician assessment (fasting glucose or average glucose on CGM\>20% and /or A1c \>0.5% from prior to ICI use ) AND /OR * If Presenting with DKA/HHS: include if within 6 weeks of presentation AND * Must have detectable random c-peptide level 0.2 - 1 ng/mL with blood glucose of 145 mg/dl * Age ≥18 years.…
Interventions
- OtherInfliximab
Given by IV
Location
- MD Anderson Cancer CenterHouston, Texas