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Post-Operative Dexamethasone for Brain Cancer

Phase 2

Waitlist Available

Led By Kimberly Hoang, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with radiographic findings consistent with either HGG, LGG, Meningioma, or brain metastasis

Age equal to or above 18

Must not have

Minors < 18

Current lymphoma or leukemia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if tapering doses of steroids can reduce side effects without worsening edema in brain tumor patients after surgery.

Who is the study for?

This trial is for adults over 18 who've had surgery to remove a brain tumor and have radiographic findings consistent with certain types of tumors. It's not for those under 18, pregnant women, people with specific immune or hormonal disorders, recent heavy corticosteroid use, or a history of solid organ transplant.

What is being tested?

The PODS Trial is testing whether decreasing doses of dexamethasone can reduce its side effects without increasing swelling risks after brain tumor surgery. The study involves CT scans, MRIs, biospecimen collection, and questionnaires to monitor outcomes.

What are the potential side effects?

Dexamethasone may cause high blood sugar levels, increased blood pressure, difficulty in wound healing among other potential side effects related to its class as a corticosteroid.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My brain scans show I might have a high-grade glioma, low-grade glioma, meningioma, or brain metastasis.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

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I have lymphoma or leukemia.

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I have a known disorder affecting my hormone levels.

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My tumor is pressing on my brain's pituitary area.

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I have had a stroke that caused lasting brain damage.

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I have been taking immunosuppressive drugs or steroids recently.

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I have a known immune system disorder such as SCID or CVID.

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I have had a solid organ transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

30-day repeat admission rate

Length of hospital stay

Need for repeat head imaging

Secondary study objectives

Breakthrough seizures

Change in lymphocyte count and differential

Evaluation for Need for Psychiatric Consult or Neuropsychiatric Side Effects

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (RDS)Experimental Treatment5 Interventions

Patients receive tapering doses of dexamethasone on days 1-4. Patients may receive dexamethasone IV and restart the taper if clinically indicated. Patients also undergo blood sample collection at time of surgery, follow up visits and optionally at wound check visit 10-14 days post operative at investigator availability. Patients additionally undergo MRI and CT scan during inpatient stay as part of standard of care.

Group II: Arm I (NDS)Experimental Treatment5 Interventions

Patients receive tapering doses of dexamethasone on days 1-15. Patients also undergo blood sample collection at time of surgery, at follow up visits and optionally at wound check visit 10-14 days post operative at investigator availability. Patients additionally undergo MRI and CT scan during inpatient stay as part of standard of care.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

2007

Completed Phase 4

~2650

Biospecimen Collection

2004

Completed Phase 3

~2020