Ultrasound-based Blood-brain Barrier Opening and Albumin-bound Paclitaxel for Recurrent Glioblastoma (SC9/ABX)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04528680|
Recruitment Status : Recruiting
First Posted : August 27, 2020
Last Update Posted : January 11, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Gliosarcoma GBM Glioblastoma Multiforme Glioblastoma, IDH-wildtype Recurrent Glioblastoma||Device: Sonication for opening of blood-brain barrier Drug: Chemotherapy, albumin-bound paclitaxel||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 / 2 Trial of Blood-brain Barrier Opening With an Implantable Ultrasound Device SonoCloud-9 and Treatment With Albumin-bound Paclitaxel in Patients With Recurrent Glioblastoma|
|Actual Study Start Date :||November 2, 2020|
|Estimated Primary Completion Date :||August 2024|
|Estimated Study Completion Date :||September 2025|
Infusion of albumin-bound paclitaxel immediately followed by sonication using the SC9 device and microbubbles in order to open the blood-brain barrier.
Device: Sonication for opening of blood-brain barrier
Implantation of SC-9 device and repeat activation of 9 ultrasound emitters during i.v. injection of microbubbles
Other Name: SonoCloud-9 device, SC-9
Drug: Chemotherapy, albumin-bound paclitaxel
Intravenous infusion of ABX over 30 minutes
- Dose limiting toxicity [ Time Frame: 1st treatment cycle = 3 weeks ]Occurrence of ≥ grade 3 treatment related toxicity
- 1-year survival rate [ Time Frame: 12-months ]Survival time from date of tumor resection and device implantation
- Incidence of side effects/toxicity associated with Sonication/ABX treatment [ Time Frame: 12 months ]Safety and tolerance
- Extent of tumor and peritumoral tissue covered by BBB opening [ Time Frame: 1st cycle (cycle = 3 weeks) ]increase in Gd contrast enhancement post sonication
- Objective response rate (RANO) [ Time Frame: 6 months ]measurement of tumor shrinkage (if there is residual disease)
- Measurement of circulating tumor DNA, methods and units for this measure are to be determined and still under evaluation. [ Time Frame: 1st cycle, cycles 2 - 6 as applicable (cycle = 3 weeks) ]compare before and after sonication
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04528680
|Contact: Christina Amidei, APN, PhD||(312) email@example.com|
|Contact: Roger Stupp, MDfirstname.lastname@example.org|
|United States, Illinois|
|Northwestern Memorial Hospital||Recruiting|
|Chicago, Illinois, United States, 60611|
|Contact: Christina Amidei, PhD, APN 312-695-9124 email@example.com|
|Principal Investigator: Adam M Sonabend, MD|
|Principal Investigator: Roger Stupp, MD|
|Sub-Investigator: Karan Dixit, MD|
|Sub-Investigator: Priya Kumthekar, MD|
|Sub-Investigator: Rimas V Lukas, MD|
|Study Chair:||Roger Stupp, MD||Northwestern University|
|Principal Investigator:||Adam M Sonabend, MD||Northwestern University|