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

Emory University

Status and phase: Enrolling; Phase 2

Conditions: Malignant Brain Glioma; Malignant Brain Neoplasm; Meningioma; Low Grade Glioma

Treatments: Other: Questionnaire Administration; Drug: Dexamethasone; Procedure: Biospecimen Collection; Procedure: Magnetic Resonance Imaging; Procedure: Computed Tomography

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06132685

P30CA138292 (U.S. NIH Grant/Contract)

WINSHIP5678-22 (Other Identifier)

NCI-2023-04702 (Registry Identifier)

STUDY00003975 (Other Identifier)

Details and patient eligibility

About

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.

Full description

PRIMARY OBJECTIVES:

I. The primary objective of this study is to evaluate the efficacy of a reduced dosage steroid schedule (RDS) in patients who have undergone craniotomy for high grade glioma (HGG), low grade glioma (LGG), brain metastasis (BM), and meningiomas as compared with the normal dosing schedule (NDS).

II. RDS after undergoing craniotomy for brain tumor has no impact on length of stay, 30 day readmission, and need for repeat imaging when compared to NDS.

SECONDARY OBJECTIVE:

I. RDS after craniotomy for brain tumor has no impact on development of steroid related side effects (new onset or worsening hypertension, hyperglycemia, wound infection, impaired wound healing, steroid dependence, neuropsychiatric disturbance) when compared to NDS.

TERTIARY/EXPLORATORY OBJECTIVE:

I. RDS after craniotomy has no effect on lymphocyte count and differential at 10-14 days after surgery.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (NDS): Patients receive tapering doses of dexamethasone on days 1-15. Patients also undergo blood sample collection at time of surgery, at follow up visits and optionally at wound check visit 10-14 days post operative at investigator availability. Patients additionally undergo magnetic resonance imaging (MRI) and computed tomography (CT) scan during inpatient stay as part of standard of care.

ARM II (RDS): Patients receive tapering doses of dexamethasone on days 1-4. Patients may receive dexamethasone intravenously (IV) and restart the taper if clinically indicated. Patients also undergo blood sample collection at time of surgery, follow up visits and optionally at wound check visit 10-14 days post operative at investigator availability. Patients additionally undergo MRI and CT scan during inpatient stay as part of standard of care.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Arm I (NDS)

Experimental group

Description:

Patients receive tapering doses of dexamethasone on days 1-15. Patients also undergo blood sample collection at time of surgery, at follow up visits and optionally at wound check visit 10-14 days post operative at investigator availability. Patients additionally undergo MRI and CT scan during inpatient stay as part of standard of care.

Treatment:

Procedure: Computed Tomography

Procedure: Magnetic Resonance Imaging

Procedure: Biospecimen Collection

Drug: Dexamethasone

Other: Questionnaire Administration

Arm II (RDS)

Experimental group

Description:

Patients receive tapering doses of dexamethasone on days 1-4. Patients may receive dexamethasone IV and restart the taper if clinically indicated. Patients also undergo blood sample collection at time of surgery, follow up visits and optionally at wound check visit 10-14 days post operative at investigator availability. Patients additionally undergo MRI and CT scan during inpatient stay as part of standard of care.

Treatment:

Procedure: Computed Tomography

Procedure: Magnetic Resonance Imaging

Procedure: Biospecimen Collection

Drug: Dexamethasone

Other: Questionnaire Administration