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Corticosteroid
Dexamethasone for Non-Small Cell Lung Cancer
N/A
Waitlist Available
Led By Anthony Shields
Research Sponsored by Barbara Ann Karmanos Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
Study Summary
This trial is testing the effects of dexamethasone on lung cancer patients who have not responded to previous treatment. Imaging tests will be used to see if dexamethasone affects how tumors grow and respond to treatments.
Eligible Conditions
- Non-Small Cell Lung Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 6-9
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 6-9
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in tumor SUVmax assessed by 18F-FLT PET imaging
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
+1 moreSide effects data
From 2013 Phase 4 trial • 122 Patients • NCT014749152%
Cerebrospinal fluid leak
2%
Deep Vein Thrombosis
2%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ondansetron
Aprepitant
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (dexamethasone, 18F-FLT PET)Experimental Treatment4 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Positron Emission Tomography
2008
Completed Phase 2
~2210
Dexamethasone
2007
Completed Phase 4
~2590
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Who is running the clinical trial?
Barbara Ann Karmanos Cancer InstituteLead Sponsor
163 Previous Clinical Trials
9,250 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,721 Previous Clinical Trials
40,965,052 Total Patients Enrolled
Anthony ShieldsPrincipal InvestigatorBarbara Ann Karmanos Cancer Institute
2 Previous Clinical Trials
8 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are expected to live for at least 4 more weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (dexamethasone, 18F-FLT PET)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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