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Low vs Standard Dose Dexamethasone for Brain Cancer
Phase 2
Recruiting
Led By Jana L Portnow
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My brain MRI shows less than 10 mm shift.
Select...
I have a brain tumor, either primary or metastatic.
Select...
I am 18 years old or older.
Select...
I can care for myself but may need occasional help.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of toxicity
Lack of feasibility
Secondary outcome measures
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 outcome measures
Qualitative assessments of cerebral edema on serial FLAIR images for pre-operative and post-operative day 1 brain MRIs
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 • NCT014749152%
Deep Vein Thrombosis
2%
Cerebrospinal fluid leak
2%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ondansetron
Aprepitant
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
~2590
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
567 Previous Clinical Trials
1,922,636 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,830 Total Patients Enrolled
Jana L PortnowPrincipal InvestigatorCity of Hope Medical Center
4 Previous Clinical Trials
114 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My brain MRI shows less than 10 mm shift.I have a brain tumor, either primary or metastatic.I have a bleeding disorder or a condition that affects how my blood clots.I am taking more than 3 mg of dexamethasone every 12 hours but can reduce it to 3 mg before surgery.I have another active cancer besides the one being studied.I have a long-lasting or active virus infection in my brain or spinal cord.My neurosurgeon expects to remove all of my brain tumor.There is no restriction on the number of previous treatments you have had to join this study.I have a new or returning brain tumor.I am 18 years old or older.I can care for myself but may need occasional help.I cannot tolerate dexamethasone.You cannot have a brain MRI.I do not have any uncontrolled illnesses or active infections.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (standard dose dexamethasone)
- Group 2: Arm II (lower dose dexamethasone)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Why is Dexamethasone prescribed to patients?
"Dexamethasone is used to treat various conditions that affect the eyes, including ophthalmia, branch retinal vein occlusion, and macular edema."
Answered by AI
Are there known risks associated with Dexamethasone?
"Dexamethasone falls into a Phase 2 category. What this means is that while there is some evidence supporting its safety, none exists yet for its efficacy."
Answered by AI
How many individuals are currently testing this treatment?
"That is accurate, the clinical trial is currently recruiting patients. According to the listing on clinicaltrials.gov, the study was first posted on April 9th, 2022 and was most recently updated on August 3rd, 2022. The study requires 24 patients at a single location."
Answered by AI
Are participants being enrolled in this experiment at the current time?
"Affirmative, the public database clinicaltrials.gov has information revealing that this study is currently looking for volunteers. This particular trial was first posted on April 9th, 2022 and was most recently updated on August 3rd, 2022. The researchers need 24 more patients to enroll at a single site."
Answered by AI
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