Dexamethasone Effects in Patients With Refractory Non-Small Cell Lung Cancer Using FLT Positron Emission Tomography

PRIMARY OBJECTIVES:

I. To evaluate the effect of dexamethasone (Dex) treatment in patients with relapsed
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).

SECONDARY OBJECTIVES:

I. Assess the reversibility of Dex-mediated changes in tumor FLT retention following the
withdrawal of Dex.

II. Measure tumor Glucocorticoid Receptor alpha expression (GRα) from recent patient biopsy
samples.

III. Analyze blood samples obtained during imaging to determine serum Dex concentration and
for senescence markers in circulating tumor cells.

OUTLINE:

Patients receive dexamethasone orally (PO) twice daily (BID) on days 1-5. Patients 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 after the 5th dose of dexamethasone, and one scan 6-9 days
after the last dose of dexamethasone.

Inclusion Criteria:

- Patients must have histologically or cytologically proven advanced non-squamous NSCLC.
Patients may have newly diagnosed recurrent progressive or refractory disease which
may be localized or wide spread.

- No chemotherapy for at least 4 weeks and no radiation to the index lesion or clear
progression in that lesion (greater than 20% increase in longest diameter).

- Life expectancy of greater than 4 weeks

- Absolute neutrophil count >= 1,000/mcL (measured within 2 weeks of registration)

- No history of human immunodeficiency virus (HIV) or active infections

- No history of diabetes

- 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

- Registered with the clinical trials office of the Karmanos Cancer Center/Wayne State
University

Exclusion Criteria:

- Patients must have measureable 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 measureable
lesions as long as there has been an increase of at least 10 mm when compared to
measurements obtained after completion of radiation