- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02819024
Dexamethasone Effects in Patients With Refractory Non-Small Cell Lung Cancer Using FLT Positron Emission Tomography
Study of the Effects of Dexamethasone on Non-Small Cell Lung Cancer Using [F-18] FLT for Imaging With Positron Emission Tomography (PET)
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Michigan
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Detroit, Michigan, United States, 48201
- Wayne State University/Karmanos Cancer Institute
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (dexamethasone, 18F-FLT PET)
Patients receive dexamethasone PO BID on days 1-5.
Patients undergo 3 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.
|
Correlative studies
Given PO BID
Other Names:
Undergo 18F-FLT PET scan
Other Names:
Undergo 18F-FLT PET scan
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in tumor SUVmax assessed by 18F-FLT PET imaging
Time Frame: Baseline to day 9
|
The primary analysis is one sample t-test for the change of SUVmax.
|
Baseline to day 9
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in senescence markers in circulating tumor cells
Time Frame: Baseline to day 9
|
Baseline to day 9
|
|
Change in serum dexamethasone concentration
Time Frame: Baseline to day 9
|
Baseline to day 9
|
|
Dexamethasone withdrawal as measured by changes in tumor FLT retention
Time Frame: Day 6-9
|
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 GRα high group.
All subgroup analyses will be descriptive due to the expected small sample size.
|
Day 6-9
|
Tumor glucocorticoid receptor alpha expression
Time Frame: Baseline
|
Baseline
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Anthony Shields, Barbara Ann Karmanos Cancer Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antimetabolites
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Protease Inhibitors
- Dermatologic Agents
- Dexamethasone
- Dexamethasone acetate
- BB 1101
- Alovudine
- Dideoxynucleosides
- Ichthammol
Other Study ID Numbers
- 2015-174 (Other Identifier: Wayne State University/Karmanos Cancer Institute)
- P30CA022453 (U.S. NIH Grant/Contract)
- NCI-2016-00881 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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