22
Participants
Start Date
February 10, 2016
Primary Completion Date
November 12, 2018
Study Completion Date
December 23, 2020
Vigil
Vigil 1.0 x 10e7 cells/injection, minimum of 4 to a maximum of 12 administrations.
Temozolomide
oral temozolimidetemozolomide 100 mg/m2 daily (Days 1 - 5, total dose 500 mg/m2/cycle)
Irinotecan
irinotecan 50 mg/m2 daily (Days 1 - 5, total dose 250mg/m2/cycle), orally or irinotecan 20mg/m2 daily (Days 1 - 5, total dose 100mg/m2/cycle ), intravenously
Gemcitabine
675 mg/m2 IV at a rate of 10 mg/m2/min on Day 1 and Day 8 every 21 days
Docetaxel
75 mg/m2 IV administered on Day 8 and every 21 days
Memorial Sloan Kettering Cancer Center, New York
Nicklaus Children's Hospital (Miami Children's Health System), Miami
Cleveland Clinic Children's, Cleveland
Arkansas Children's Hospital, Little Rock
Mary Crowley Cancer Research Centers, Dallas
TOPA - Medical City Dallas Pediatric Hematology-Oncology, Dallas
Lead Sponsor
Gradalis, Inc.
INDUSTRY