Status:
RECRUITING
Post-Operative Dosing of Dexamethasone in Patients with Brain Tumors After a Craniotomy, PODS Trial
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Low Grade Glioma
Malignant Brain Glioma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 stand...
Detailed 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)...
Eligibility Criteria
Inclusion
- Patients with radiographic findings consistent with either HGG, LGG, Meningioma, or brain metastasis
- Age equal to or above 18
Exclusion
- 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
Key Trial Info
Start Date :
January 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2028
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06132685
Start Date
January 9 2025
End Date
July 30 2028
Last Update
January 15 2025
Active Locations (1)
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1
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322