Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-08623 | Other Identifier | NCI-CTRP Clinical Registry |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To find out if taking a drug called infliximab (the "study drug") is safe and effective in reversing insulin dependence in CIADM.
Primary Objective
1. To estimate the efficacy of infliximab in reversing insulin dependence in CIADM.
Secondary Objective
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pilot Study Treatment wiith Infliximab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infliximab | Other | Given by IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and adverse events (AEs). | Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 | Through study completion; an average of 1 year. |
Not provided
Not provided
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:
Age ≥18 years. Because adverse event data are currently available on the use of infliximab in combination within participants <18 years of age, children are excluded from this study.
ECOG performance status ≤2 (Karnofsky ≥60%,).
Participants must have adequate organ and marrow function as defined below:
absolute neutrophil count ≥1,000/mcL platelets ≥100,000/mcL total bilirubin ≤ institutional upper limit of normal (ULN) AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN creatinine ≤ institutional ULN
Cardiac ejection fraction > 50%
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Priyanka C Iyer, MD | Contact | 832) 291-6069 | piyer@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Priyanka C Iyer, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
Not provided
| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069285 | Infliximab |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |