This pilot phase II trial studies the effects of dexamethasone in patients with non-small cell lung cancer that is newly diagnosed, has come back, or is growing, spreading, or getting worse. Drugs such as dexamethasone can affect how tumors grow and respond to treatments. Imaging tests, such as fluoro-L-thymidine (FLT) positron emission tomography, use a small amount of radioactive substance to show changes in tumor cells. Studying the effects of dexamethasone on lung tumors using FLT positron emission tomography may help doctors plan better treatments.
Additional locations may be listed on ClinicalTrials.gov for NCT02819024.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. To evaluate the effect of dexamethasone (Dex) treatment in patients with non-squamous non-small cell lung cancer (NSCLC) using 3’-fluorothymidine (FLT) positron emission tomography (PET) as measured by changes in tumor maximum standardized uptake value (SUVmax), SUVmean, and SUVpeak.
SECONDARY OBJECTIVES:
I. Measure tumor glucocorticoid receptor alpha expression (GRalpha) from tumor tissues, when available.
II. Analyze blood samples obtained during imaging to determine serum Dex concentration, counts and activation status of peripheral blood mononuclear cells, and plasma levels of cytokines and chemokines associated with tumor senescence.
OUTLINE:
Patients receive dexamethasone orally (PO) twice daily (BID) for a total of 14 days in the absence of disease progression or unacceptable toxicity. Patients also undergo 3 fluorothymidine F-18 (18F)-FLT PET scans. One scan within 7 days prior to the start of dexamethasone, one scan on day 3 or days 13-14 of dexamethasone treatment, and one scan 6-9 days after the last dose of dexamethasone. Patients may continue dexamethasone treatment after the third FLT PET scan at the discretion of treating physician.
Lead OrganizationWayne State University/Karmanos Cancer Institute
Principal InvestigatorAnthony Frank Shields