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

Overseen by Anthony Shields

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Barbara Ann Karmanos Cancer Institute

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Anthony Shields

Principal Investigator

Barbara Ann Karmanos Cancer Institute

Eligibility Criteria

Inclusion Criteria

No history of human immunodeficiency virus (HIV) or active infections

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

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

Treatment Details

Interventions

• Dexamethasone (Corticosteroid)

Participant Groups

Group I: Treatment (dexamethasone, 18F-FLT PET) Experimental Treatment 4 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.

Dexamethasone is already approved in Canada, Japan for the following indications:

Approved in Canada as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases

Approved in Japan as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders

Who Is Running the Clinical Trial?

Barbara Ann Karmanos Cancer Institute

Lead Sponsor

Trials

166

Recruited

9,300+

Dr. Boris C. Pasche

Barbara Ann Karmanos Cancer Institute

Chief Executive Officer since 2023

MD, PhD

Dr. Ann Schwartz

Barbara Ann Karmanos Cancer Institute

Chief Medical Officer since 2010

PhD in Epidemiology, University of Michigan

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School