Low Dose Versus Standard Dose Dexamethasone for Reduction of Swelling in Patients with Primary or Metastatic Brain Tumors

NCT05139043 | Active Not Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: 20624NCI-2021-11292P30CA033572
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Malignant Brain Neoplasm; Metastatic Malignant Neoplasm in the Brain; Recurrent Malignant Brain Neoplasm

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to 30 days

Secondary Outcomes (2)

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

  Up to 30 days

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

  Up to 30 days

Other Outcomes (2)

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

  At pre-operative and post-operative day 1

• Qualitative assessments of cerebral edema on serial FLAIR images for pre-operative and post-operative day 1 brain MRIs

  At pre-operative and post-operative day 1

Study Arms (2)

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.

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.

Drug: Dexamethasone

Interventions

Dexamethasone DRUG

Given IV and PO

Also known as: Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex, Alin, Alin Depot, Alin Oftalmico, Amplidermis, Anemul mono, Auricularum, Auxiloson, Baycadron, Baycuten, Baycuten N, Cortidexason, Cortisumman, Decacort, Decadrol, Decadron, Decadron DP, Decalix, Decameth, Decasone R.p., Dectancyl, Dekacort, Deltafluorene, Deronil, Desamethasone, Desameton, Dexa-Mamallet, Dexa-Rhinosan, Dexa-Scheroson, Dexa-sine, Dexacortal, Dexacortin, Dexafarma, Dexafluorene, Dexalocal, Dexamecortin, Dexameth, Dexamethasone Intensol, Dexamethasonum, Dexamonozon, Dexapos, Dexinoral, Dexone, Dinormon, Dxevo, Fluorodelta, Fortecortin, Gammacorten, Hemady, Hexadecadrol, Hexadrol, Lokalison-F, Loverine, Methylfluorprednisolone, Millicorten, Mymethasone, Orgadrone, Spersadex, TaperDex, Visumetazone, ZoDex

Arm I (standard dose dexamethasone); Arm II (lower dose dexamethasone)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Dexamethasone; Calcium Dobesilate; auricularum; dexamethasone acetate; dexamethasone 21-phosphate

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Jana L Portnow, MD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: December 1, 2021
• Study Start: April 9, 2022
• Primary Completion: September 3, 2025
• Study Completion: September 3, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

US (1)