Dexamethasone Effects in Patients with Newly Diagnosed, Recurrent, or Progressive Non-Small Cell Lung Cancer Using FLT Positron Emission Tomography

Status: Active

Description

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.

Eligibility Criteria

Inclusion Criteria

  • Patients must have histologically or cytologically proven newly diagnosed, recurrent, progressive, refractory or non-refractory non-squamous NSCLC, which may be localized or widespread
  • Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques (computed tomography [CT], magnetic resonance [MR] or PET); lesions in the previously irradiated area can be considered as measurable lesions as long as there has been an increase of at least 10 mm when compared to measurements obtained after completion of radiation
  • No chemotherapy for at least 4 weeks and no radiation to the index lesion or clear progression in that lesion (greater than 20% and at least 10 mm increase in longest diameter)
  • Life expectancy of greater than 4 weeks
  • Absolute neutrophil count >= 1,000/mcL (measured within 6 weeks of registration)
  • No history of human immunodeficiency virus (HIV) or active infections
  • Random blood glucose of =< 300 mg/dl if history of diabetes mellitus
  • No surgery in the last 2 weeks prior to study enrollment
  • Has not received Dex or another corticosteroid in over 4 weeks prior to enrollment
  • Ability to understand and the willingness to sign a written informed consent document
  • Agreed to FLT-PET imaging and signed consent and eligible FLT-PET protocol 2006-127

Locations & Contacts

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: Active
Contact: Anthony Frank Shields
Phone: 313-576-8735
Email: shieldsa@karmanos.org

Trial Objectives and Outline

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.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Diagnostic

Lead Organization

Lead Organization
Wayne State University / Karmanos Cancer Institute

Principal Investigator
Anthony Frank Shields

Trial IDs

Primary ID 2015-174
Secondary IDs NCI-2016-00881
Clinicaltrials.gov ID NCT02819024