Dose starting at 4 mg daily (for patients randomized to the Dexamethasone arm).

Dose starting at 25 mg/day (a calculation of equipotent steroid equivalencies will be used).

Brain Metastases, Adult

The study intervention is defined as treatment with either prednisone or dexamethasone as palliative therapy for the control of neurological symptoms; patients with symptomatic brain metastases with a requirement for glucocorticoid therapy will be treated with an available, standard-of-care immune checkpoint inhibitor regimen.

Glucocorticoid therapy

Cross Cancer Institute

Accelerated Checkpoint Therapy for Any Steroid Dependent Patient With Brain Metastases

An Interventional, Randomized Phase II Study Investigating the Efficacy of Immune Checkpoint Inhibitors While Corticosteroid Therapy is Required for Patients With Symptomatic Brain Metastases.

Objective response rate will be determined utilizing RECIST 1.1 criteria. Baseline staging diagnostic imaging (CT and/or MRI studies) will be performed in advance of beginning treatment and repeated 6 weeks following treatment initiation and at 12 week intervals thereafter.

Defined as the time interval between first radiographic documentation of intracranial metastatic disease and initiation of systemic immunotherapy.

Secondary study outcomes include progression-free and overall survival (PFS, OS). PFS is defined as the time between the date of treatment initiation and the date of disease progression (determined utilizing RECIST 1.1 criteria) or death (whatever the cause), whichever occurs first. For participants who remain alive and whose disease has not progressed, PFS will be censored on the date of last visit/contact with disease assessments. PFS will be based on the disease assessment or date of death provided by the investigator. OS is defined as the time between the date of treatment initiation and the date of death (whatever the cause). For participants who remain alive OS will be censored on the date of last visit/contact with disease assessments. OS will be based on the date of death provided by the investigator.

An analysis of patient-reported quality of life will be conducted utilizing the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the EORTC Brain Cancer Module (EORTC QLQ-BN20) questionnaires). Quality of life questionnaires will be administered to participants following enrolment to study but prior to initiation of immunotherapy. Follow-up questionnaires will be administered as part of the standard of care immunotherapy pre-treatment starting 6 weeks from Cycle 1 and every 6 weeks thereafter until end of treatment. Quality of life questionnaires should be administered prior to investigator assessment at each indicated time-point.

The Common Terminology Criteria for Adverse Events (CTCAE, version 4.03) will be used to categorize treatment related and non-treatment related adverse events.

AHS Cancer Control Alberta

Open label, two cohort, permuted block randomization phase II study.

Primary Central Nervous System Lymphoma

Methotrexate

Methylprednisolone

Temozolomide

Changhua Christian Hospital

China Medical University Hospital

National Cheng Kung University Hospital

Mackay Memorial Hospital

a Phase II Study in Primary Central Nervous System Lymphoma

High-Dose Methotrexate Plus Steroid Followed by Concurrent Whole Brain Chemoradiation With Temozolomide for Immunocompetent Patients With Primary Central Nervous System Lymphoma - a Phase II Study

National Health Research Institutes, Taiwan

National Taiwan University Hospital

National Cheng-Kung University Hospital

Chi Mei Medical Hospital

Taichung Veterans General Hospital

administered iv for 3 h every 21 days; dose reductions to 12 or 9 mg/m2 ZK-EPO were allowed in order to manage any treatment-related toxicity.

skin neoplasms/seizures

Accelerated Checkpoint Therapy for Any Steroid Dependent Patient With Brain Metastases

a Phase II Study in Primary Central Nervous System Lymphoma

Epothilone in Recurrent Glioblastoma Patients

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