Correlation of Serum Vitamin D Level With the Development of Endocrine Autoimmune Complications During Treatment With Immune Checkpoint Inhibitors
Icahn School of Medicine at Mount Sinai
Summary
The purpose of this research study is to see if the amount of vitamin D in ones blood makes it more or less likely to develop thyroid gland toxicity when being treated with immunotherapy that blocks the activity of proteins called programed death-1(PD-1) or programmed death ligand-1 (PD-L1). Immunotherapy is treatment that makes changes to the immune system to try to fight cancer. Immunotherapy treatments that block the activity of important parts of the immune system called PD-1 and PD-L1 are used to standardly treat many different types of cancer and can cause thyroid toxicity in certain people. In this study the treatment for your cancer is not research treatment but standard of care determined by your oncologist. Blood will be drawn before starting treatment to determine the amount of Vitamin D and also to assess thyroid function. Also questionnaires will be completed before starting treatment and while on treatment to assess symptoms you are experiencing.
Description
Until 2011 no therapy with proven overall survival benefit was Food and Drug Administration (FDA) approved for the treatment of stage IV (disseminated) melanoma. In 2011 ipilimumab, an inhibitor of CTLA-4, was FDA approved for the treatment of stage IV melanoma representing the first immunotherapy to confer an increase in overall survival. CTLA-4 is expressed on the surface of activated T cells and binds to B7 on antigen-presenting cells with higher affinity than the co-stimulatory protein CD28. By competing for and disrupting the binding of CD28 to B7, CTLA-4 prevents T-cell co-stimulation wh…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Malignancy which the treating oncologist plans for next treatment to inhibit PD-1or PD-L1 with the immune inhibitor being the only immunotherapy. Twenty-five subjects in a separate cohort will need for eligibility to be planned for treatment with anti-PD1/PD-L1 plus antri-CTLA-4 therapy. * Willingness to complete symptom questionnaires * Willingness to allow blood draws * Ability to provide informed consent * Age \> 18 years old Exclusion Criteria: * History of clinical or subclinical hyperthyroidism or hypothyroidism * Hemoglobin \< 9 * Inability to come for all study…
Interventions
- Otherblood draw and questionnaire completion
questionaires provided to subjects during visits while on study and baseline one tube of blood drawn
- Otherquestionnaire completion, blood collection
questionnaire provided to subject during study visits. One tube blood collected for research purposes at baseline
Location
- Mount Sinai Hospital /Tisch Cancer Cancer/Ruttenberg Treatment CenterNew York, New York