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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: Active Phase 1 study of Glioblastoma and Glioblastoma Multiforme, sponsored by Northwestern University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Occurrence of ≥ grade 3 treatment related toxicity
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 |
What the registry record for NCT04528680 still lists
NCT04528680 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (48% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT04528680's enrollment target sits among peer trials
57 82nd of 199 higher than 118 of 199 other Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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