Clinical trial NCT02819024: Dexamethasone Effects in Patients With Refractory Non-Small Cell Lung Cancer Using FLT Positron Emission Tomography
Official title: Study of the Effects of Dexamethasone on Non-Small Cell Lung Cancer Using [F-18] FLT for Imaging With Positron Emission Tomography (PET)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Recurrent Non-Small Cell Lung Carcinoma
Stage IIIA Non-Small Cell Lung Cancer
Stage IIIB Non-Small Cell Lung Cancer
Stage IV Non-Small Cell Lung Cancer
Lead sponsor: Barbara Ann Karmanos Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-06-30
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This pilot research trial studies the effects of dexamethasone in patients with non-small cell lung cancer that has not responded after previous treatment. 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in tumor SUVmax assessed by 18F-FLT PET imaging
timeFrame: Baseline to day 9
Secondary outcomes:
measure: Change in senescence markers in circulating tumor cells
timeFrame: Baseline to day 9
measure: Change in serum dexamethasone concentration
timeFrame: Baseline to day 9
measure: Dexamethasone withdrawal as measured by changes in tumor FLT retention
timeFrame: Day 6-9
measure: Tumor glucocorticoid receptor alpha expression
timeFrame: Baseline
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Wayne State University/Karmanos Cancer Institute
state: Michigan
Study officials:
affiliation: Barbara Ann Karmanos Cancer Institute
name: Anthony Shields
role: PRINCIPAL_INVESTIGATOR
References: