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)
Verified date | May 2023 |
Source | Barbara Ann Karmanos Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Wayne State University/Karmanos Cancer Institute | Detroit | Michigan |
Lead Sponsor | Collaborator |
---|---|
Barbara Ann Karmanos Cancer Institute | National Cancer Institute (NCI) |
United States,
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 |
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