A Dose Escalation Phase I Study Of Human- Recombinant Bone Morphogenetic Protein 4 Administrated Via CED In GBM Patients

PHASE1CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

July 18, 2017

Primary Completion Date

October 16, 2020

Study Completion Date

June 30, 2021

Conditions
Glioblastoma
Interventions
DRUG

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."

Trial Locations (4)

20133

Istituto Neurologico Carlo Besta, Milan

Unknown

Tel Aviv Sourasky Medical Center, Tel Aviv

1081 HV

VU University Medical Center, Amsterdam

3015 GD

Erasmus University Medical Center, Department of Neurosurgery, Rotterdam

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

ORION Clinical Services

INDUSTRY

lead

Stemgen

INDUSTRY