A Randomized, Open-label, Multicentric, Two-arm Pivotal Trial of SonoCloud-9 Combined With Carboplatin (CBDCA) vs Standard of Care Lomustine (CCNU) or Temozolomide (TMZ) in Patients Undergoing Planned Resection for First Recurrence Glioblastoma

Clinical Trial Details

This clinical trial is for adults who have a brain tumor (glioblastoma) that has gotten worse despite first treatment and for whom additional surgery and chemotherapy are being recommended to treat their tumor.

The purpose of this research is to learn if the investigational SonoCloud-9 (SC9) implantable device can be used in combination with carboplatin chemotherapy to help control glioblastoma at recurrence. SC9 is an investigational device specially developed to allow an opening of the blood-brain barrier (abbreviated as the BBB), in the area of and surrounding the area of the tumor at the time of a chemotherapy cycle. If this barrier can be opened, making the BBB temporarily more permeable, chemotherapy given into a vein in a participant’s arm (intravenous infusion) may be able to better reach the brain tumor. SC9 and carboplatin are not approved by the U.S Food and Drug Administration (FDA) for treatment of glioblastoma, so their use in the study is considered experimental.

Participants in this research will be put into two groups, selected by chance, as if by tossing a coin (randomization):

One group will be given SC9 together with Carboplatin (group EA, experimental arm). The SC9 with Carboplatin treatment cycles are planned to be repeated every 3 weeks.
The other group (group CA, control arm) will be given Lomustine or Temozolomide, standard-of-care chemotherapy prescribed for glioblastoma at recurrence. Lomustine and Temozolomide are taken orally in capsules at home.

As part of their routine care, participants will be asked to undergo surgery to remove the tumor that has come back. If a participant is in the experimental arm (group EA), the surgeon will insert the SC9 implant into the skull bone at the end of the tumor resection surgery. If a participant is in the control arm (group CA), the surgeon will close the wound without implanting the SC9 device.

Participants will be closely monitored during their treatment, which will last up to 7 months. After the end of treatment, participants will be followed up to 48 months by their study doctor to further collect information about their disease status.

Key Eligibility:

Adults with histologically proven glioblastoma, absence of IDH mutation.
Patient must have received prior first line therapy that must have contained both prior surgery or biopsy and standard fractionated radiotherapy or hypofractionated radiotherapy; and one line of maintenance chemotherapy and/or immune- or biological therapy.
Patient is a candidate for craniotomy and at least 50% resection of enhancing region.

Detailed eligibility will be reviewed when participant contacts the study team.

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Study contact by location

Upper East Side - Manhattan

Contact(s)

Devonie Manzano, RN
212-746-7117
dgm4004@med.cornell.edu

Primary Investigator(s)

Rohan Ramakrishna, MD

Protocol ID(s)

Weill Cornell Medicine IRB #:

2401026999

ClinicalTrials.gov:

NCT05902169

Status

Open to Enrollment

Age Group

Adult

Disease

Brain Tumor

Glioblastoma

Surgery