57 Participants Needed

Ultrasound-assisted Chemotherapy for Glioblastoma

(SC9/ABX Trial)

CA
NS
Roger Stupp, MD profile photo
Overseen ByRoger Stupp, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on enzyme-inducing antiepileptics or need to continue antiplatelet therapy, you may not be eligible to participate.

What data supports the effectiveness of the treatment for glioblastoma?

Research shows that using ultrasound to open the blood-brain barrier can increase the concentration of carboplatin in brain tissue, potentially improving its effectiveness against glioblastoma. Additionally, carboplatin has shown some effectiveness in glioblastoma when used before radiation therapy, with a median survival of 19.2 months.12345

Is the combination of paclitaxel and carboplatin generally safe for humans?

The combination of paclitaxel and carboplatin has been studied in various cancers, showing that it is generally well tolerated. Common side effects include low blood cell counts, hair loss, mild muscle pain, and fatigue, with some rare cases of severe allergic reactions.678910

What makes ultrasound-assisted chemotherapy for glioblastoma unique?

This treatment uses ultrasound to temporarily open the blood-brain barrier, allowing higher concentrations of chemotherapy drugs like carboplatin and paclitaxel to reach the brain, which is not possible with standard intravenous delivery.211121314

What is the purpose of this trial?

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 the phase 1 component, increasing doses of chemotherapy will be delivered as long deemed safe based on the prior patient not experiencing severe toxicity. Once the the recommended dosing has been established, carboplatin will be added to the regimen and 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 and when feasible, 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 may occur immediately after the test dose of chemotherapy is administered.The objectives of this trial are to establish a safe and effective dose of albumin-bound paclitaxel, 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.

Research Team

RS

Roger Stupp, MD

Principal Investigator

Northwestern University

AM

Adam M Sonabend, MD

Principal Investigator

Northwestern University

Eligibility Criteria

Adults over 18 with a specific type of brain cancer called IDH1 wild-type glioblastoma, who are fit for surgery and have had up to two prior treatments. They must not be pregnant, agree to use contraception, and have stable vital organ functions. Excluded are those with uncontrolled epilepsy, certain allergies or medical conditions that conflict with the trial's procedures.

Inclusion Criteria

It has been over 12 weeks since I finished my radiation therapy.
For patients with a childbearing potential
Be willing and able to comply with the protocol for the duration of the study
See 15 more

Exclusion Criteria

Have an uncontrolled intercurrent illness
Have clinical evidence of peripheral neuropathy on examination
I cannot take Abraxane or carboplatin due to health reasons.
See 13 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Resection and Device Implantation

Eligible patients undergo craniotomy for tumor resection and implantation of the sonication device. A test dose of chemotherapy may be administered.

1 day
1 visit (in-person)

Phase 1 Treatment

Sonication and administration of albumin-bound paclitaxel every 3 weeks to establish a safe dose. Blood samples collected for circulating tumor DNA.

Until disease progression
Every 3 weeks (in-person)

Phase 2 Treatment

Addition of carboplatin to the regimen with sonication and albumin-bound paclitaxel administration every 3 weeks.

Until disease progression
Every 3 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment completion.

12 months

Treatment Details

Interventions

  • Carboplatin
  • Paclitaxel
  • Sonication for opening of blood-brain barrier
Trial Overview The trial tests if using ultrasound to open the blood-brain barrier before giving chemotherapy (albumin-bound paclitaxel followed by carboplatin) can safely improve treatment outcomes in recurrent glioblastoma patients. The study will determine safe dosages and measure how well this method delivers chemo into the tumor.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: SC9/ABX (phase 1); SC9/ABX/Carboplatin (phase 2)Experimental Treatment3 Interventions
Infusion of albumin-bound paclitaxel immediately followed by sonication using the SC9 device and microbubbles in order to open the blood-brain barrier in phase 1. In phase 2, patients will receive carboplatin immediately prior to sonication using the SC9 device and microbubbles in order to open the blood-brain barrier, then will receive albumin-bound paclitaxel upon completion of sonication.

Carboplatin is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Paraplatin for:
  • Ovarian cancer
  • Testicular cancer
  • Lung cancer
  • Head and neck cancer
  • Brain cancer
🇪🇺
Approved in European Union as Carboplatin for:
  • Ovarian cancer
  • Small cell lung cancer
🇨🇦
Approved in Canada as Carboplatin for:
  • Ovarian cancer
  • Small cell lung cancer
  • Testicular cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials
1,674
Recruited
989,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

CarThera

Industry Sponsor

Trials
6
Recruited
710+

Bristol-Myers Squibb

Industry Sponsor

Trials
2,731
Recruited
4,127,000+
Headquarters
New York City, USA
Known For
Oncology & Cardiovascular
Top Products
Eliquis, Opdivo, Revlimid, Orencia
Christopher Boerner profile image

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Lantheus Medical Imaging

Industry Sponsor

Trials
57
Recruited
4,333,000+

Findings from Research

In a study of 84 glioblastoma patients, various chemotherapy combinations including cisplatin and carboplatin showed tolerability and efficacy, with no statistically significant differences in treatment effectiveness among the groups.
Patients treated with carboplatin had a significantly longer survival time compared to those treated with BCNU, with over half of the carboplatin-treated patients alive at 18 months, indicating a beneficial effect of platinum-based chemotherapy on glioblastoma.
Carboplatin combined with carmustine and etoposide in the treatment of glioblastoma.Boiardi, A., Silvani, A., Milanesi, I., et al.[2019]
Using ultrasound to open the blood-brain barrier significantly increased the concentration of carboplatin in brain tissue by 5.2 times in the targeted area, suggesting a more effective delivery method for treating glioblastoma.
This method of enhancing drug delivery is currently being evaluated in a phase 1 clinical trial, indicating its potential as a promising approach for improving treatment outcomes in patients with aggressive brain tumors.
Enhanced brain distribution of carboplatin in a primate model after blood-brain barrier disruption using an implantable ultrasound device.Goldwirt, L., Canney, M., Horodyckid, C., et al.[2016]
In a study involving 883 chemotherapy-naive patients with advanced-stage non-small cell lung cancer, both weekly and every-3-week schedules of paclitaxel and carboplatin showed similar efficacy in terms of response rates and survival times.
While both treatment schedules were well tolerated, the weekly schedule had a lower incidence of severe sensory neuropathy (4.4% vs. 9.1%), whereas the every-3-week schedule had a lower incidence of severe diarrhea (1.1% vs. 4.2%), highlighting the importance of considering side effects when choosing a treatment plan.
Multicenter randomized trial for stage IIIB/IV non-small-cell lung cancer using every-3-week versus weekly paclitaxel/carboplatin.Schuette, W., Blankenburg, T., Guschall, W., et al.[2019]

References

Carboplatin combined with carmustine and etoposide in the treatment of glioblastoma. [2019]
Enhanced brain distribution of carboplatin in a primate model after blood-brain barrier disruption using an implantable ultrasound device. [2016]
Multicenter randomized trial for stage IIIB/IV non-small-cell lung cancer using every-3-week versus weekly paclitaxel/carboplatin. [2019]
The added value of bevacizumab concomitantly administered with carboplatin versus carboplatin alone in patients with recurrent glioblastomas. [2017]
Carboplatin chemotherapy before irradiation in newly diagnosed glioblastoma multiforme. [2019]
Carboplatin and paclitaxel in ovarian cancer. [2015]
Preliminary results of two dose-finding studies of paclitaxel (Taxol) and carboplatin in non-small cell lung and ovarian cancers: a European Cancer Centre effort. [2015]
Paclitaxel and carboplatin in combination in the treatment of advanced non-small-cell lung cancer (NSCLC): a preliminary study. [2015]
Paclitaxel and carboplatin in nonoperable non-small cell lung cancer. [2015]
10.United Statespubmed.ncbi.nlm.nih.gov
Efficacy and safety of the combination paclitaxel/carboplatin in patients with previously treated advanced ovarian carcinoma: a multicenter French Groupe des Investigateurs Nationaux pour l'Etude des Cancers Ovariens phase II study. [2015]
11.United Statespubmed.ncbi.nlm.nih.gov
Ultrasound-mediated Delivery of Paclitaxel for Glioma: A Comparative Study of Distribution, Toxicity, and Efficacy of Albumin-bound Versus Cremophor Formulations. [2021]
12.United Statespubmed.ncbi.nlm.nih.gov
Safety and Feasibility of Repeated and Transient Blood-Brain Barrier Disruption by Pulsed Ultrasound in Patients with Recurrent Glioblastoma. [2019]
Repeated blood-brain barrier opening with an implantable ultrasound device for delivery of albumin-bound paclitaxel in patients with recurrent glioblastoma: a phase 1 trial. [2023]
14.United Statespubmed.ncbi.nlm.nih.gov
Biomimetic Nanosonosensitizers Combined with Noninvasive Ultrasound Actuation to Reverse Drug Resistance and Sonodynamic-Enhanced Chemotherapy against Orthotopic Glioblastoma. [2023]
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