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

Stage IV Non-Small Cell Lung Cancer Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02819024
• Other study ID #: 2015-174
• Secondary ID: NCI-2016-0088120
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2016
• Est. completion date: November 2023

Study information

• Verified date: May 2023
• Source: Barbara Ann Karmanos Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6
• Est. completion date: November 2023
• Est. primary completion date: November 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• 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

Intervention

Drug:
• Dexamethasone
Given PO BID

Device:
• Device for PET
Undergo 18F-FLT PET scan

Other:
• Laboratory Biomarker Analysis
Correlative studies

Procedure:
• Positron Emission Tomography
Undergo 18F-FLT PET scan

Locations

Country	Name	City	State
United States	Wayne State University/Karmanos Cancer Institute	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Barbara Ann Karmanos Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in tumor SUVmax assessed by 18F-FLT PET imaging	The primary analysis is one sample t-test for the change of SUVmax.	Baseline to day 9
Secondary	Change in senescence markers in circulating tumor cells		Baseline to day 9
Secondary	Change in serum dexamethasone concentration		Baseline to day 9
Secondary	Dexamethasone withdrawal as measured by changes in tumor FLT retention	Secondary analyses will be carried out with descriptive statistics such as mean, SD, range. Correlation analysis will be descriptive. Spearman correlation coefficient will be calculated and scatter plot will be plotted. Subgroup analyses for dexamethasone withdrawal will be performed within the GRa high group. All subgroup analyses will be descriptive due to the expected small sample size.	Day 6-9
Secondary	Tumor glucocorticoid receptor alpha expression		Baseline