RECRUITINGPhase 2INTERVENTIONAL

Post-Operative Dosing of Dexamethasone in Patients With Brain Tumors After a Craniotomy, PODS Trial

Post-Operative Dosing of Steroids Post Craniotomy for Brain Tumor (PODS)

About This Trial

This phase II trial tests the effect of decreasing (tapering) doses of dexamethasone on steroid side effects in patients after surgery to remove (craniotomy) a brain tumor. Steroids are the gold standard post-surgery treatment to reduce swelling (edema) at the surgical site to reduce neurological symptoms. Although, corticosteroids reduce edema, they have side effects including high blood sugar, high blood pressure, and can impair wound healing. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response. It also works to treat other conditions by reducing swelling and redness. Tapering doses dexamethasone may decrease steroid side effects without increasing the risk of edema in patients with brain tumors after a craniotomy.

Who May Be Eligible (Plain English)

Who May Qualify: - Patients with radiographic findings consistent with either HGG, LGG, Meningioma, or brain metastasis - Age equal to or above 18 Who Should NOT Join This Trial: - Known hypothalamic-pituitary-adrenal (HPA) axis dysfunction - Tumor causing compression of the sella or pituitary dysfunction - Known weakened immune system - including but not limited to severe combined weakened immune system (SCID), common variable weakened immune system (CVID), lymphocytopenia - Taking immunosuppressive drugs - including but not limited to methotrexate, mycophenolate, rapamycin, tacrolimus, adalimumab, infliximab. Greater than two weeks of recent daily corticosteroid use or the use of corticosteroids equivalent to \> 85 mg of dexamethasone in the last month - Current lymphoma or leukemia - History of solid organ transplant - Minors \< 18 - Pregnant women - History of cerebrovascular accident leading to neurologic deficit Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Patients with radiographic findings consistent with either HGG, LGG, Meningioma, or brain metastasis * Age equal to or above 18 Exclusion Criteria: * Known hypothalamic-pituitary-adrenal (HPA) axis dysfunction * Tumor causing compression of the sella or pituitary dysfunction * Known immunodeficiency - including but not limited to severe combined immunodeficiency (SCID), common variable immunodeficiency (CVID), lymphocytopenia * Taking immunosuppressive drugs - including but not limited to methotrexate, mycophenolate, rapamycin, tacrolimus, adalimumab, infliximab. Greater than two weeks of recent daily corticosteroid use or the use of corticosteroids equivalent to \> 85 mg of dexamethasone in the last month * Current lymphoma or leukemia * History of solid organ transplant * Minors \< 18 * Pregnant women * History of cerebrovascular accident leading to neurologic deficit

Treatments Being Tested

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Computed Tomography

Undergo CT scan

DRUG

Dexamethasone

Given dexamethasone or IV

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

OTHER

Questionnaire Administration

Ancillary studies

Locations (1)

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States