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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-00881 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2015-174 | Other Identifier | Wayne State University/Karmanos Cancer Institute | |
| P30CA022453 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (dexamethasone, 18F-FLT PET) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | Given PO BID |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Tumor SUVmax Assessed by 18F-FLT PET Imaging | The primary endpoint is reported with mean and standard deviation | Baseline to day 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Fold Change in Senescence Marker Gro-alpha | Fold change in senescence marker Gro-alpha from scan 1 to scan 3 | Baseline to day 9 |
| Fold Change in Senescence Marker Gro-beta | Fold change in senescence marker Gro-alpha from scan 1 to scan 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Shields | Barbara Ann Karmanos Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wayne State University/Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Dexamethasone: Given PO BID Device for PET: Undergo 18F-FLT PET scan Laboratory Biomarker Analysis: Correlative studies Positron Emission Tomography: Undergo 18F-FLT PET scan |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 11, 2019 |
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| Device for PET | Device | Undergo 18F-FLT PET scan |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
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| Positron Emission Tomography | Procedure | Undergo 18F-FLT PET scan |
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| Baseline to day 9 |
| Fold Change in Senescence Marker MCP-1 | Fold change in senescence marker Gro-alpha from scan 1 to scan 3 | Baseline to day 9 |
| Tumor Glucocorticoid Receptor Alpha Expression | Baseline |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Dexamethasone: Given PO BID Device for PET: Undergo 18F-FLT PET scan Laboratory Biomarker Analysis: Correlative studies Positron Emission Tomography: Undergo 18F-FLT PET scan |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change in Tumor SUVmax Assessed by 18F-FLT PET Imaging | The primary endpoint is reported with mean and standard deviation | Posted | Mean | Standard Deviation | SUVmax | Baseline to day 9 |
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| Secondary | Fold Change in Senescence Marker Gro-alpha | Fold change in senescence marker Gro-alpha from scan 1 to scan 3 | Posted | Mean | Standard Deviation | fold change is unitless | Baseline to day 9 |
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| Secondary | Fold Change in Senescence Marker Gro-beta | Fold change in senescence marker Gro-alpha from scan 1 to scan 3 | Posted | Mean | Standard Deviation | fold change is unitless | Baseline to day 9 |
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| Secondary | Fold Change in Senescence Marker MCP-1 | Fold change in senescence marker Gro-alpha from scan 1 to scan 3 | Posted | Mean | Standard Deviation | fold change is unitless | Baseline to day 9 |
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| Secondary | Tumor Glucocorticoid Receptor Alpha Expression | Needle biopsies were collected for routine care. There was not enough tissue left after the routine care analyses to perform the exploratory analysis specified in this endpoint. | Posted | Baseline |
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From the date of informed consent until the 3rd scan 6~8 days after scheduled Dex treatment, an average of 5 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Dexamethasone: Given PO BID Device for PET: Undergo 18F-FLT PET scan Laboratory Biomarker Analysis: Correlative studies Positron Emission Tomography: Undergo 18F-FLT PET scan | 0 | 5 | 0 | 5 | 0 | 5 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anthony F. Shields, MD, PhD | Barbara Ann Karmanos Cancer Institute | 3135768735 | shieldsa@karmanos.org |
| Aug 17, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| C059464 | auricularum |
| C018038 | dexamethasone acetate |
| C004180 | dexamethasone 21-phosphate |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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