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

Primary Purpose

Recurrent Non-Small Cell Lung Carcinoma, Stage IIIA Non-Small Cell Lung Cancer, Stage IIIB Non-Small Cell Lung Cancer

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Dexamethasone

Device for PET

Laboratory Biomarker Analysis

Positron Emission Tomography

About this trial

This is an interventional diagnostic trial for Recurrent Non-Small Cell Lung Carcinoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Wayne State University/Karmanos Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (dexamethasone, 18F-FLT PET)

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in tumor SUVmax assessed by 18F-FLT PET imaging

The primary analysis is one sample t-test for the change of SUVmax.

Secondary Outcome Measures

Change in senescence markers in circulating tumor cells

Change in serum dexamethasone concentration

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 GRα high group. All subgroup analyses will be descriptive due to the expected small sample size.

Tumor glucocorticoid receptor alpha expression

Full Information

NCT ID

NCT02819024

First Posted

June 20, 2016

Last Updated

May 4, 2023

Sponsor

Barbara Ann Karmanos Cancer Institute

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT02819024

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

June 2016 (undefined)

Primary Completion Date

November 8, 2022 (Actual)

Study Completion Date

November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Barbara Ann Karmanos Cancer Institute

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment (dexamethasone, 18F-FLT PET)

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Other Intervention Name(s)

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

Intervention Description

Given PO BID

Intervention Type

Device

Intervention Name(s)

Device for PET

Other Intervention Name(s)

18F-FLT, 3'-Deoxy-3'-(18F) Fluorothymidine, 3'-deoxy-3'-[18F]fluorothymidine, Fluorothymidine F 18, FLUOROTHYMIDINE F-18

Intervention Description

Undergo 18F-FLT PET scan

Intervention Type

Other

Intervention Name(s)

Laboratory Biomarker Analysis

Intervention Description

Correlative studies

Intervention Type

Procedure

Intervention Name(s)

Positron Emission Tomography

Other Intervention Name(s)

Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

Intervention Description

Undergo 18F-FLT PET scan

Primary Outcome Measure Information:

Title

Change in tumor SUVmax assessed by 18F-FLT PET imaging

Description

The primary analysis is one sample t-test for the change of SUVmax.

Time Frame

Baseline to day 9

Secondary Outcome Measure Information:

Title

Change in senescence markers in circulating tumor cells

Time Frame

Baseline to day 9

Title

Change in serum dexamethasone concentration

Time Frame

Baseline to day 9

Title

Dexamethasone withdrawal as measured by changes in tumor FLT retention

Description

Time Frame

Day 6-9

Title

Tumor glucocorticoid receptor alpha expression

Time Frame

Baseline

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anthony Shields

Organizational Affiliation

Barbara Ann Karmanos Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wayne State University/Karmanos Cancer Institute

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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