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Title:
Pembrolizumab in Patients with Leptomeningeal Disease
Protocol Number:
J16156
Phase:
Phase II
Physician:
Jarushka Naidoo
Sites:
Johns Hopkins Bayview Medical Center
Johns Hopkins Kimmel Cancer Center in Baltimore
Purpose:
Primary objective is to determine whether Pembrolizumab induces a radiologic, cytologic or clinical response in the CNS in patients with leptomeningeal disease from solid tumors. The secondary objective is to determine if pembrolizumab improves progression free survival, overall survival and is safe and tolerable in this population.
Eligibility:
Patients greater than 18 years old and in good condition will have histological or cytological confirmed solid malignancy with measurable brain or spine lesion that has not been radiated within 3 months of study therapy or positive cerebral spinal fluid (CSF). Any prior line of therapies alloed, but must have received available therapies for primary disease as deemed appropriate by treating investigato. WBXRT may be used without wahout period if lesion to be radiated is not the sole measueable disease. Patient may continue a targeted therapy if CNS disease developed while receiving agent & deemed safe when combined with PD-1 therapy. Patient with escalating steroids, history of autoimmune disease or pneumonitis or prior disease progression on anti-PD1 are excluded from participation.
Treatment:
Study Overview/Treatment: Eligible patients will receive baseline MRI brain & spine and CT chest, abdomen & pelvis and lumbar puncture for CSF evaluation. This will be repeated again after 2 & 4 cycles of Pembrolizumab (each cycle is 3 weeks). If patient shows a clinical benefit, can continue Pembrolizumab every 3 weeks.
Population:
Adult
Last Update
03/05/2019 05:03 AM