Low vs Standard Dose Dexamethasone for Brain Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: City of Hope Medical Center

Must be taking: Dexamethasone

Disqualifiers: CNS infection, Coagulopathy, Active malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a lower dose of dexamethasone, a corticosteroid, can control brain swelling as effectively as the standard dose after brain surgery. Dexamethasone reduces brain swelling but often causes many side effects. Researchers aim to determine if a reduced dosage can maintain effectiveness while minimizing side effects. This trial may suit individuals with a primary or metastatic brain tumor who can manage on a lower dose of dexamethasone before surgery. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications, but you must be able to reduce your dexamethasone dose to 3 mg every 12 hours by 3 days before surgery to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that dexamethasone can help reduce brain swelling. However, higher doses might cause more side effects without improving results. In past studies, patients on higher doses experienced more negative reactions, such as increased infections or mood changes.

Researchers are currently studying whether lower doses of dexamethasone can control brain swelling as effectively, but with fewer side effects. This trial is in the middle phase, indicating that early tests have suggested the treatment is fairly safe. However, more information is needed for confirmation. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard of care for brain cancer, which often involves higher doses of dexamethasone, this treatment explores the effectiveness of lower doses. Researchers are excited because using a lower dose could minimize side effects while still effectively managing symptoms. This approach could lead to better quality of life for patients by reducing common steroid-related issues like weight gain, mood swings, and increased infection risk, without compromising on treatment efficacy.

What evidence suggests that low dose dexamethasone could be an effective treatment for brain swelling after surgery?

This trial will compare the effectiveness of standard-dose dexamethasone with lower-dose dexamethasone in reducing brain swelling after surgery for brain tumors. Research has shown that dexamethasone can help reduce brain swelling, and studies have found both regular and lower doses to be effective. One study suggested that lower doses might control swelling as well as regular doses, potentially leading to fewer side effects. Patients often take 4 mg twice a day, a common dosage that has improved conditions without added risk. The trial aims to find the lowest dose that effectively controls brain swelling while minimizing side effects. ^{1 2 4 6 7}

Who Is on the Research Team?

Jana Portnow, MD

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My brain MRI shows less than 10 mm shift.

I have a brain tumor, either primary or metastatic.

I am taking more than 3 mg of dexamethasone every 12 hours but can reduce it to 3 mg before surgery.

Exclusion Criteria

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

I have another active cancer besides the one being studied.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Treatment

Patients undergo brain surgery and receive dexamethasone (standard or low dose) before and after surgery

1 day

1 visit (in-person)

Post-operative Treatment

Patients receive dexamethasone (standard or low dose) for 14 days post-surgery, with tapering from day 4 to 14

14 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Dexamethasone

Trial Overview 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.

How Is the Trial Designed?

Group I: Arm II (lower dose dexamethasone) Experimental Treatment 1 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 Control 1 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.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Dexamethasone (DEXA) effectively reduces glioma tumor growth in mice and rodents, with low concentrations inhibiting cell proliferation and higher concentrations inducing cell death, while also causing cellular stress responses in treated cells.

In human gliomas, DEXA shows variable effectiveness, with some cell lines resistant to its effects; however, DEXA does not harm normal brain cells, indicating its potential for neuroprotective effects while reducing tumor-induced damage and angiogenesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexamethasone alleviates tumor-associated brain damage and angiogenesis. Fan, Z., Sehm, T., Rauh, M., et al.[2021]

Dexamethasone is commonly used in patients with brain tumors undergoing neurosurgery to reduce inflammation and manage symptoms, highlighting its efficacy in this specific context.

The review also emphasizes the potential adverse effects of dexamethasone, which are important for both neurosurgeons and anesthetists to consider when administering this medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexamethasone for intracranial neurosurgery and anaesthesia. Hockey, B., Leslie, K., Williams, D.[2013]

Dexamethasone (Dex) significantly reduces the sensitivity of C6 glioma cells to methotrexate (MTX), allowing more cells to survive even at high concentrations of MTX.

This protective effect of Dex was also observed in human TE671 cells, indicating that the interaction between Dex and MTX is not limited to a specific species.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexamethasone induced partial resistance to methotrexate in C6-glioma cells. Wolff, JE., Jürgens, H.[2013]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11011080/

Dexamethasone in Patients with Glioblastoma - PubMed Central We found that dexamethasone indeed significantly reduces overall and progression-free survival in glioblastoma patients, even when accounting for clinical ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05139043

Study Details | NCT05139043 | Low Dose Versus Standard ... This phase II trial studies whether low dose dexamethasone works as well as standard dose dexamethasone to reduce brain swelling after brain surgery.

3. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1632231/full

Dexamethasone in brain tumor patients: a real-world ... Among patients initiated on steroids, the most common regimen was 4 mg twice daily (36.6%), followed by an 8 mg loading dose plus 4 mg twice daily (20.7%).

4. neurology.org neurology.org/doi/10.1212/WNL.44.4.675

Dose‐effect relationship of dexamethasone on Karnofsky ... The purpose of this study was to determine whether lower doses of dexamethasone for treatment of brain tumor edema are as effective as the conventional dose of

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2832545

Practice Variation in Perioperative Dexamethasone Use ... This comparative effectiveness study evaluates whether the cumulative dose of dexamethasone is associated with overall and progression-free ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6700052/

Evidence-based dexamethasone dosing in malignant brain ... Best available evidence suggests that higher doses of DXM may give more adverse events, but may not necessarily result in better clinical condition.

7. cancer.gov cancer.gov/news-events/cancer-currents-blog/2020/brain-cancer-immunotherapy-steroids-limit-effectiveness

Steroids Impair Immunotherapy for Brain Cancer - NCI Dexamethasone and Brain Tumors​​ Dexamethasone is a highly effective drug for managing symptoms associated with brain tumors, including headaches ...