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NCT04528680 · ClinicalTrials.gov registry record · Phase 1
Ultrasound-based Blood-brain Barrier Opening and Albumin-bound Paclitaxel and Carboplatin for Recurrent Glioblastoma
A Phase 1 study of Glioblastoma and Glioblastoma Multiforme, sponsored by Northwestern University.
- Active
- Registry status
- Phase 1
- Development phase
- 57
- Enrollment target
- 1
- Study location
NCT04528680 is a Phase 1 study of Glioblastoma and Glioblastoma Multiforme that is active but no longer recruiting, run by Northwestern University. The registered enrollment target is 57 participants, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (48% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04528680, a Phase 1 study of Glioblastoma and Glioblastoma Multiforme, is active but no longer recruiting, sponsored by Northwestern University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 57 participants
- Enrollment target
- 1
- Study location
Study 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 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.
Conditions Studied
Interventions
- DEVICE Sonication for opening of blood-brain barrier
- DRUG Chemotherapy, albumin-bound paclitaxel
- DRUG Chemotherapy, carboplatin
Study Locations (1)
Illinois
- Northwestern Memorial Hospital - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2020-10-29 |
| Est. Completion | 2025-11-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04528680
The ClinicalTrials.gov registry entry for NCT04528680 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (48% lower). The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Glioblastoma appearing as the primary indexed condition, and to 3 interventions - of which Sonication for opening of blood-brain barrier is the first listed.
NCT04528680 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.
Frequently Asked Questions
What is clinical trial NCT04528680 about?
NCT04528680 is a clinical study titled "Ultrasound-based Blood-brain Barrier Opening and Albumin-bound Paclitaxel and Carboplatin for Recurrent Glioblastoma". 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...
What is the current status of trial NCT04528680?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 57 participants. The study started on 2020-10-29. Estimated completion is 2025-11-30.
What conditions does trial NCT04528680 study?
This clinical trial studies the following conditions: Glioblastoma, Glioblastoma Multiforme, Recurrent Glioblastoma, Gliosarcoma, GBM.
What interventions are being tested in trial NCT04528680?
The interventions under investigation include: Sonication for opening of blood-brain barrier (DEVICE), Chemotherapy, albumin-bound paclitaxel (DRUG), Chemotherapy, carboplatin (DRUG).
Who is sponsoring clinical trial NCT04528680?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04528680 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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