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.

This group will be treated with everolimus 7-28 days prior to surgery

This group will be enrolled as reference subjects, and will be undergoing routine surgery as part of standard of care treatment. No intervention will be provided to these subjects as part of the study.

Epilepsy

Tuberous Sclerosis Complex

Focal Cortical Dysplasia

This study will measure if the drug called Everolimus effects mTOR signaling (an electrical activity signal in the brain) in patients with Tuberous Sclerosis Complex (TSC) and Focal Cortical Dysplasia (FCD) with treatment resistant epilepsy (TRE) who will be undergoing brain surgery. One group of patients will be treated with Everolimus, for 7-28 days prior to epilepsy surgery and another will not. We will determine if there is a difference in mTOR signaling between the patients who were treated with Everolimus and those who were not

Everolimus

New York University Langone Medical Center

A Pilot Study To Evaluate The Effects of Everolimus on Brain mTOR Activity and Cortical Hyperexcitability in TSC and FCD

.Adverse event monitoring should be continued for at least 30 days (or 5 half-lives, whichever is longer) following the last dose of study treatment

MTor signaling is measured by peripheral VEGF-D levels, Blood and brain levels of cytokines (and TNF-α) and inflammatory proteins (HMGB1)at the time of surgery, Brain glutamate and GABA receptor expression at the time of surgery, and Blood levels of everolimus at the time of surgery

NYU Langone Health

All Patients

Sex: Female, Male

Region of Enrollment

The Size of Intestinal Polyps

Overall Study

Dr. Randall Burt

Peutz-Jeghers Syndrome

Everolimus is a novel derivative of rapamycin. Everolimus has been in clinical development since 1996 as an immunosuppressant in solid organ transplantation. Since 2003, RAD001 is approved in Europe (trade name: Certican) via the Mutual Recognition Procedure (MRP) for the prevention of organ rejection in patients with renal and cardiac transplantation. Certican is also approved in Australia, South Africa, the Middle East, Central and South America, the Caribbean and some Asian countries.
Everolimus is being investigated as an anticancer agent based on its potential to act
directly on the tumor cells by inhibiting tumor cell growth and proliferation
indirectly by inhibiting angiogenesis leading to reduced tumor vascularity (via potent inhibition of tumor cell VEGF production and VEGF-induced proliferation of endothelial cells.

kidney neoplasms/seizures

Accelerated Checkpoint Therapy for Any Steroid Dependent Patient With Brain Metastases

A Pilot Study To Evaluate The Effects of Everolimus on Brain mTOR Activity and Cortical Hyperexcitability in TSC and FCD

Pilot Study of mTOR Inhibitor Therapy in Peutz-Jeghers Syndrome

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