NCT02819024

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 30, 2016

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2019

Completed
5.9 years until next milestone

Results Posted

Study results publicly available

August 22, 2025

Completed
Last Updated

August 22, 2025

Status Verified

July 1, 2025

Enrollment Period

3.4 years

First QC Date

June 20, 2016

Results QC Date

June 26, 2024

Last Update Submit

August 5, 2025

Conditions

Recurrent Non-Small Cell Lung CarcinomaStage IIIA Non-Small Cell Lung CancerStage IIIB Non-Small Cell Lung CancerStage IV Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Change in Tumor SUVmax Assessed by 18F-FLT PET Imaging

    The primary endpoint is reported with mean and standard deviation

    Baseline to day 9

Secondary Outcomes (4)

  • Fold Change in Senescence Marker Gro-alpha

    Baseline to day 9

  • Fold Change in Senescence Marker Gro-beta

    Baseline to day 9

  • Fold Change in Senescence Marker MCP-1

    Baseline to day 9

  • Tumor Glucocorticoid Receptor Alpha Expression

    Baseline

Study Arms (1)

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.

Drug: DexamethasoneDevice: Device for PETOther: Laboratory Biomarker AnalysisProcedure: Positron Emission Tomography

Interventions

DexamethasoneDRUG

Given PO BID

Also known as: Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex, Alin, Alin Depot, Alin Oftalmico, Amplidermis, Anemul mono, Auricularum, Auxiloson, Baycuten, Baycuten N, Cortidexason, Cortisumman, Decacort, Decadrol, Decadron, Decalix, Decameth, Decasone R.p., Dectancyl, Dekacort, Deltafluorene, Deronil, Desamethasone, Desameton, Dexa-Mamallet, Dexa-Rhinosan, Dexa-Scheroson, Dexa-sine, Dexacortal, Dexacortin, Dexafarma, Dexafluorene, Dexalocal, Dexamecortin, Dexameth, Dexamethasonum, Dexamonozon, Dexapos, Dexinoral, Dexone, Dinormon, Fluorodelta, Fortecortin, Gammacorten, Hexadecadrol, Hexadrol, Lokalison-F, Loverine, Methylfluorprednisolone, Millicorten, Mymethasone, Orgadrone, Spersadex, Visumetazone
Treatment (dexamethasone, 18F-FLT PET)
Device for PETDEVICE

Undergo 18F-FLT PET scan

Also known as: 18F-FLT, 3'-Deoxy-3'-(18F) Fluorothymidine, 3'-deoxy-3'-[18F]fluorothymidine, Fluorothymidine F 18, FLUOROTHYMIDINE F-18
Treatment (dexamethasone, 18F-FLT PET)
Laboratory Biomarker AnalysisOTHER

Correlative studies

Treatment (dexamethasone, 18F-FLT PET)
Positron Emission TomographyPROCEDURE

Undergo 18F-FLT PET scan

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Treatment (dexamethasone, 18F-FLT PET)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

DexamethasoneCalcium Dobesilateauricularumdexamethasone acetatedexamethasone 21-phosphateMagnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedBenzenesulfonatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur CompoundsSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Results Point of Contact

Title
Anthony F. Shields, MD, PhD
Organization
Barbara Ann Karmanos Cancer Institute
shieldsa@karmanos.org
3135768735

Study Officials

  • Anthony Shields

    Barbara Ann Karmanos Cancer Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 20, 2016

First Posted

June 30, 2016

Study Start

June 1, 2016

Primary Completion

October 17, 2019

Study Completion

October 17, 2019

Last Updated

August 22, 2025

Results First Posted

August 22, 2025

Record last verified: 2025-07

Locations

US(1)