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Corticosteroid
Dexamethasone Effects in Patients With Refractory Non-Small Cell Lung Cancer Using FLT Positron Emission Tomography
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 day 6-9
Awards & highlights
No Placebo-Only Group
Summary
This trial studies the effects of dexamethasone, a steroid medication, in patients with non-small cell lung cancer that hasn't responded to other treatments. The medication may change how the cancer cells grow, and doctors use special imaging tests to monitor these changes. Dexamethasone has been shown to inhibit the growth of non-small cell lung cancer cells and affect their development.
Eligible Conditions
- Non-Small Cell Lung Cancer
- 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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in tumor SUVmax assessed by 18F-FLT PET imaging
Secondary study objectives
Dexamethasone withdrawal as measured by changes in tumor FLT retention
Side effects data
From 2013 Phase 4 trial • 122 Patients • NCT014749152%
Deep Vein Thrombosis
2%
Cerebrospinal fluid leak
2%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ondansetron
Aprepitant
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
2011
Completed Phase 2
~2200
Dexamethasone
2007
Completed Phase 4
~2650
Find a Location
Who is running the clinical trial?
Barbara Ann Karmanos Cancer InstituteLead Sponsor
164 Previous Clinical Trials
9,242 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,023,164 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.