15
Participants
Start Date
July 18, 2017
Primary Completion Date
October 16, 2020
Study Completion Date
June 30, 2021
hrBMP4
"Patients will undergo a resection or biopsy of the tumour, confirmation of viable malignant glioma tumour cells and intratumour/interstitial placement under neuronavigational guidance of 2 or 3 catheters.~Catheters will be placed during a second procedure a few days later based upon the patient's condition.~Patients will receive intra-tumour and interstitial CED of increasing amounts of hrBMP4 solutions (starting dose of 0.5 mg) and 1:70 gadolinium-diethylenetriamine pentaacetic acid (Gd-DTPA) in a total of 44-66ml over up to 4-6 days. Gd-DTPA will be co-infused with BMP4 to determine the extent of intra-tumour and interstitial drug delivery. HrBMP4 will be delivered as a continuous infusion via the intracranial catheters."
Istituto Neurologico Carlo Besta, Milan
Tel Aviv Sourasky Medical Center, Tel Aviv
VU University Medical Center, Amsterdam
Erasmus University Medical Center, Department of Neurosurgery, Rotterdam
Lead Sponsor
Collaborators (1)
ORION Clinical Services
INDUSTRY
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INDUSTRY