Ultrasound-based Blood-brain Barrier Opening and Albumin-bound Paclitaxel for Recurrent Glioblastoma
Status:
Recruiting
Trial end date:
2025-09-01
Target enrollment:
Participant gender:
Summary
Paclitaxel is among the most active agents against glioblastoma in preclinical models.
However, its clinical use has been hampered by the blood-brain barrier (BBB). In this trial
we will implant a novel device with 9 ultrasound emitters allowing to temporarily and
reversibly open the BBB immediately prior to chemotherapy infusion with albumin-bound
paclitaxel.
In this phase 1 trial increasing doses of chemotherapy will be delivered as long deemed safe
and prior patient had not experienced severe toxicity. Once the the recommended dosing has
been established, additional patients will be treated in order to better evaluate the
antitumor efficacy of this novel treatment.
The device will be implanted at the time of surgical resection of the recurrent tumor. During
that procedure a first test dose of the chemotherapy will be administered in the operating
room after sonication (procedure of activating ultrasound and opening the BBB) and tissue
concentrations in different parts of the resected tumor will be measured. In select patients,
the sonication procedure will occur immediately after the test dose of chemotherapy is
administered.
The objectives of this trial are to establish a safe and effective dose of ABX, to
demonstrate that the opening of the BBB increases chemotherapy concentration in the tumor,
and to estimate how effective this treatment is in reducing the tumor burden and prolonging
life.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Northwestern University
Collaborators:
Bristol-Myers Squibb CarThera Lantheus Medical Imaging