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Low vs Standard Dose Dexamethasone for Brain Cancer

Phase 2

Waitlist Available

Led By Jana L Portnow, MD

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

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

Must have

Participant must have less than 10 mm of midline shift seen on pre-op brain magnetic resonance imaging (MRI)

Participant has a primary or metastatic brain tumor(s)

Must not have

Participant has a coagulopathy or bleeding disorder

Participant has another active malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a lower dose of dexamethasone can reduce brain swelling after surgery for brain tumors, with the goal of minimizing side effects.

Who is the study for?

This trial is for adults over 18 with primary or metastatic brain tumors, able to reduce pre-surgery dexamethasone to a specified level and undergo complete tumor removal. They must have stable vital signs, no active infections or other cancers, and not be in another clinical trial.

What is being tested?

The study compares low versus standard doses of dexamethasone for reducing brain swelling post-surgery in patients with brain tumors. It aims to find the minimum effective dose that controls swelling while minimizing side effects.

What are the potential side effects?

Dexamethasone may cause increased blood sugar levels, mood swings, trouble sleeping, weight gain around the stomach area, thinning skin that bruises easily, muscle weakness and difficulty fighting infections.

Eligibility Criteria

Inclusion Criteria

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

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My brain MRI shows less than 10 mm shift.

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I have a brain tumor, either primary or metastatic.

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I am 18 years old or older.

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I can care for myself but may need occasional help.

Exclusion Criteria

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

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I have a bleeding disorder or a condition that affects how my blood clots.

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I have another active cancer besides the one being studied.

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I have a long-lasting or active virus infection in my brain or spinal cord.

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I cannot tolerate dexamethasone.

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I do not have any uncontrolled illnesses or active infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of toxicity

Lack of feasibility

Secondary study objectives

Qualitative assessments of cerebral edema on serial fluid-attenuated inversion recovery (FLAIR) images for each post-surgery brain MRI

Volume of cerebral edema for each post-surgery brain magnetic resonance imaging (MRI)

Other study objectives

Volume of cerebral edema for pre-operative and post-operative day 1 brain MRIs as measured by STAGE

Side effects data

From 2013 Phase 4 trial • 122 Patients • NCT01474915

Deep Vein Thrombosis

Cerebrospinal fluid leak

Fever

100%

80%

60%

40%

20%

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

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (lower dose dexamethasone)Experimental Treatment1 Intervention

Patients receive lower dose dexamethasone PO q 12 h for 3 days. On the day of surgery, patients receive lower dose dexamethasone IV before and after the surgery. Patients receive lower dose dexamethasone IV q 12 h on days 1-3 post surgery and tapered dexamethasone PO q 12 h on days 4-14 in the absence of disease progression or unacceptable toxicity. Additional doses of dexamethasone are given if needed.

Group II: Arm I (standard dose dexamethasone)Active Control1 Intervention

Patients receive standard dose dexamethasone PO q 12 h for 3 days. On the day of surgery, patients receive standard dose dexamethasone IV before and after the surgery. Patients receive standard dose dexamethasone IV q 12 h on days 1-3 post surgery and tapered dexamethasone PO q 12 h on days 4-14 in the absence of disease progression or unacceptable toxicity. Additional doses of dexamethasone are given if needed.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

2007

Completed Phase 4

~2650

0 / 9Eligibility criteria met