Low vs Standard Dose Dexamethasone for Brain Cancer

Recruiting in Palo Alto (17 mi)

Jana Portnow, M.D., neuro-oncologist ...

Overseen byJana Portnow, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

+7 more

Exclusion Criteria

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

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

I have another active cancer besides the one being studied.

+4 more

Participant Groups

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.

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.