Malignant Brain NeoplasmPhase 2NCT05139043
Low Dose Versus Standard Dose Dexamethasone for Reduction of Swelling in Patients with Primary or Metastatic Brain Tumors
A Phase 2 study testing Dexamethasone in people with Malignant Brain Neoplasm and Metastatic Malignant Neoplasm in the Brain, run by City of Hope Medical Center at 1 site in United States.
Trial summary
This phase II trial studies whether low dose dexamethasone works as well as standard dose dexamethasone to reduce brain swelling after brain surgery in patients with primary brain tumors or cancer that has spread from other places in the body to the brain (metastatic). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Brain Neoplasm, Metastatic Malignant Neoplasm in the Brain, Recurrent Malignant Brain Neoplasm
- What is being tested?
- Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2022to 3 Sep 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is 18 years or older.
- Participant has a Karnofsky Performance Status of >= 60%.
- Participant has a primary or metastatic brain tumor(s).
- Participant can have newly diagnosed or recurrent brain tumor(s).
- If a participant is requiring more than 3 mg orally every 12 hours (q 12 h) of dexamethasone at the time of signing the consent form, it is anticipated by the neurosurgeon that the participant will be able to taper down their dose of dexamethasone to 3 mg orally q 12 h by 3 days before the surgery.
- (Note: If the patient is not able to decrease their dose of dexamethasone to 3 mg orally q 12 h 3 days before surgery, the patient will not be allowed to participate in the study.)
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- Participant must have less than 10 mm of midline shift seen on pre-op brain magnetic resonance imaging (MRI).
- The neurosurgeon anticipates being able to perform a gross total resection of tumor.
- Participant is not planning to participate in another clinical trial during the study period.
- There is no limit to the number of prior therapies for enrollment in this study.
- All participants must have the ability to understand and the willingness to sign a written informed consent.
Who cannot join
- Participant is unable to undergo a brain MRI.
- Participant is unable to tolerate dexamethasone.
- Participant has a chronic or active viral infection of the central nervous system (CNS).
- Participant has a coagulopathy or bleeding disorder.
- Participant has an uncontrolled illness including ongoing or active infection.
- Participant has another active malignancy.
- A patient has a serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the safety monitoring requirements and completion of treatment according to this protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: Safety and Imaging of Post-Operative Low Dose Versus Standard Dose Dexamethasone in Patients with Primary or Metastatic Brain Tumors: a Randomized, Double-blinded Feasibility Study.
This phase II trial studies whether low dose dexamethasone works as well as standard dose dexamethasone to reduce brain swelling after brain surgery in patients with primary brain tumors or cancer that has spread from other places in the body to the brain (metastatic). Surgery is an important part of the treatment of brain tumors; however, it results in injury to surrounding brain tissue, leading to brain swelling. Dexamethasone is effective for controlling the swelling of the brain; however, dexamethasone can cause many unwanted side effects. To minimize the side effects of dexamethasone, the lowest dose needed to control swelling of the brain should be used. This research study is assessing the safety of using a lower than standard dose of dexamethasone after the surgery to control brain swelling.
Read the detailed description
PRIMARY OBJECTIVES:
- Assess the feasibility of administering lower doses of dexamethasone post-operatively in patients who have mild to moderate cerebral edema pre-operatively.
II. Describe the toxicity profile associated with post-operative lower doses and standard doses of dexamethasone, separately.
SECONDARY OBJECTIVES:
- Descriptively assess the consistency between the quantitative data produced by strategically acquired gradient echo (STAGE) and qualitative assessments of changes in cerebral edema on serial fluid-attenuated inversion recovery (FLAIR) images.
II. Quantitatively assess changes in the volume of cerebral edema post-operatively in participants on Arm 1 (standard dose) and Arm 2 (low dose).
EXPLORATORY OBJECTIVE:
- Describe changes in the volume of cerebral edema between pre-operative and post-operative day 1 brain magnetic resonance imaging (MRIs) in Arm 1 (standard dose) and Arm 2 (low dose) participants, separately.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive standard dose dexamethasone orally (PO) every 12 hours (q 12 h) for 3 days. On the day of surgery, patients receive standard dose dexamethasone intravenously (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.
ARM II: 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.
After completion of surgery, patients are followed up after 30 days.
- Conditions
- Malignant Brain Neoplasm, Metastatic Malignant Neoplasm in the Brain, Recurrent Malignant Brain Neoplasm
- Being tested
- Dexamethasone
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex
Given IV and PO
| Study group | Role | What they receive |
|---|---|---|
| Arm I (standard dose dexamethasone) | Active comparator | 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. Receives: Drug: Dexamethasone |
| Arm II (lower dose dexamethasone) | Experimental | 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. Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lack of feasibility
Defined as a participant requiring more than 18 mg of dexamethasone beyond the planned dose per treatment arm during the 9 day period from surgery through post-operative day 8. Feasibility will be monitored sequentially (after each patient completes study treatment), by arm. The feasibility review boundary is based on a Wald sequential probability ratio test. Rates and associated 90% Clopper and Pearson binomial confidence limits will be estimated.
Measured: Up to post-operative day 8
Incidence of toxicity
All grade toxicities attributed to dexamethasone at the possible or above level. All toxicities and side effects will be summarized in tables by organ, severity, and attribution. Rates and associated 90% Clopper and Pearson binomial confidence limits will be estimated.
Measured: Up to 30 days
Secondary outcomes (2)
Volume of cerebral edema for each post-surgery brain magnetic resonance imaging (MRI)
Measured by strategically acquired gradient echo (STAGE).
Measured: Up to 30 days
Qualitative assessments of cerebral edema on serial fluid-attenuated inversion recovery (FLAIR) images for each post-surgery brain MRI
Descriptive statistics will be provided for cerebral edema volume as measure by STAGE for each arm by strata and time point.
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start9 Apr 2022
- Primary completion3 Sep 2025 (estimated)
- Study completion3 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Brain NeoplasmStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jana L Portnow, MD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05139043
- Sponsor's protocol ID
- 20624
- Other IDs
- NCI-2021-11292, 20624, P30CA033572
- Status last verified
- Sep 2024
- First submitted
- 22 Nov 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Imaging of Post-Operative Low Dose Versus Standard Dose Dexamethasone in Patients with Primary or Metastatic Brain Tumors: a Randomized, Double-blinded Feasibility Study.
- ClinicalTrials.gov ID
- NCT05139043
- Acronym / sponsor ID
- 20624
- Conditions
- Malignant Brain Neoplasm, Metastatic Malignant Neoplasm in the Brain, Recurrent Malignant Brain Neoplasm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 9 Apr 2022 (actual)
- Primary completion
- 3 Sep 2025 (estimated)
- Study completion
- 3 Sep 2025 (estimated)
- First posted
- 1 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies whether low dose dexamethasone works as well as standard dose dexamethasone to reduce brain swelling after brain surgery in patients with primary brain tumors or cancer that has spread from other places in the body to the brain (metastatic). Surgery is an important part of the treatment of brain tumors; however, it results in injury to surrounding brain tissue, leading to brain swelling. Dexamethasone is effective for controlling the swelling of the brain; however, dexamethasone can cause many unwanted side effects. To minimize the side effects of dexamethasone, the lowest dose needed to control swelling of the brain should be used. This research study is assessing the safety of using a lower than standard dose of dexamethasone after the surgery to control brain swelling.
Detailed description
PRIMARY OBJECTIVES:
- Assess the feasibility of administering lower doses of dexamethasone post-operatively in patients who have mild to moderate cerebral edema pre-operatively.
II. Describe the toxicity profile associated with post-operative lower doses and standard doses of dexamethasone, separately.
SECONDARY OBJECTIVES:
- Descriptively assess the consistency between the quantitative data produced by strategically acquired gradient echo (STAGE) and qualitative assessments of changes in cerebral edema on serial fluid-attenuated inversion recovery (FLAIR) images.
II. Quantitatively assess changes in the volume of cerebral edema post-operatively in participants on Arm 1 (standard dose) and Arm 2 (low dose).
EXPLORATORY OBJECTIVE:
- Describe changes in the volume of cerebral edema between pre-operative and post-operative day 1 brain magnetic resonance imaging (MRIs) in Arm 1 (standard dose) and Arm 2 (low dose) participants, separately.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive standard dose dexamethasone orally (PO) every 12 hours (q 12 h) for 3 days. On the day of surgery, patients receive standard dose dexamethasone intravenously (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.
ARM II: 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.
After completion of surgery, patients are followed up after 30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (standard dose dexamethasone) | Active comparator | Drug: DexamethasonePatients 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. |
| Arm II (lower dose dexamethasone) | Experimental | Drug: DexamethasonePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Participant is 18 years or older.
- Participant has a Karnofsky Performance Status of >= 60%.
- Participant has a primary or metastatic brain tumor(s).
- Participant can have newly diagnosed or recurrent brain tumor(s).
- If a participant is requiring more than 3 mg orally every 12 hours (q 12 h) of dexamethasone at the time of signing the consent form, it is anticipated by the neurosurgeon that the participant will be able to taper down their dose of dexamethasone to 3 mg orally q 12 h by 3 days before the surgery.
Key exclusion criteria (7 listed)
- Participant is unable to undergo a brain MRI.
- Participant is unable to tolerate dexamethasone.
- Participant has a chronic or active viral infection of the central nervous system (CNS).
- Participant has a coagulopathy or bleeding disorder.
- Participant has an uncontrolled illness including ongoing or active infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneAlso: Aacidexam, Adexone, Aknichthol Dexa, Alba-DexGiven IV and PO | Drug | Arm I (standard dose dexamethasone), Arm II (lower dose dexamethasone) |
Primary outcome
Lack of feasibility
Time frame: Up to post-operative day 8
Defined as a participant requiring more than 18 mg of dexamethasone beyond the planned dose per treatment arm during the 9 day period from surgery through post-operative day 8. Feasibility will be monitored sequentially (after each patient completes study treatment), by arm. The feasibility review boundary is based on a Wald sequential probability ratio test. Rates and associated 90% Clopper and Pearson binomial confidence limits will be estimated.
Incidence of toxicity
Time frame: Up to 30 days
All grade toxicities attributed to dexamethasone at the possible or above level. All toxicities and side effects will be summarized in tables by organ, severity, and attribution. Rates and associated 90% Clopper and Pearson binomial confidence limits will be estimated.
2 secondary outcomes
Volume of cerebral edema for each post-surgery brain magnetic resonance imaging (MRI)
Time frame: Up to 30 days
Qualitative assessments of cerebral edema on serial fluid-attenuated inversion recovery (FLAIR) images for each post-surgery brain MRI
Time frame: Up to 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jana L Portnow, MD principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexamethasone in people with Malignant Brain Neoplasm and Metastatic Malignant Neoplasm in the Brain, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lack of feasibility (time frame: Up to post-operative day 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.