A randomized, open-label, multicentric, two-arm pivotal trial of SonoCoud-9 combined with carboplatin (CBDCA) vs standard of care lomustine (CCNU) or temozolomide (TMZ) in patients undergoing planned resection for first recurrence glioblastoma
Study of Sonocloud 9 in Patients with Glioblastoma (GBM)
Sponsor: Carthera
Enrolling: Male and Female Patients
IRB Number: AAAU9708
U.S. Govt. ID: NCT05902169
Contact: Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu
Additional Study Information: The purpose of this study is to see if the implantable device, Sonocloud 9, is effective getting chemotherapy to better reach your tumor compared to receiving standard-of-care chemotherapy Temozolomide and Lomustine and to see how safe and tolerable the device is. Sonocloud 9 works by making the blood-brain barrier (BBB) more permeable (allowing liquids or gases to go through it) so chemotherapy can better reach your tumor. The BBB is a natural sealing of the blood vessels in the brain. This study is being done in participants whose brain tumor has returned and are eligible for surgery to have it removed. SC9 is an investigational device specially developed to allow an opening of the BBB in the area of and surrounding area of the tumor at the time of a chemotherapy cycle. Investigational means that the device is not approved by the U.S. Food and Drug Administration (FDA). Chemotherapy associated with BBB opening by Sonocloud-9 is Carboplatin. Carboplatin is a drug that has been used for treatment of ovarian cancer for over 30 years and it is used in combination with other drugs, to treat different cancer types. Carboplatin is also recommended in National Comprehensive Cancer Network guidelines for the treatment of glioblastoma. It is not approved by the U.S Food and Drug Administration (FDA) for treatment of glioblastoma, however, so its use in the study is considered experimental. In the laboratory, it is known to kill glioblastoma tumor cells, but it crosses the BBB poorly.
Brian Gill, MD
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