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

• Status: Not yet recruiting
• Trial end date: 2028-07-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Collaborator: National Cancer Institute (NCI)
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate; Ichthammol

Criteria

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