Status:
ACTIVE_NOT_RECRUITING
Ultrasound-based Blood-brain Barrier Opening and Albumin-bound Paclitaxel and Carboplatin for Recurrent Glioblastoma
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
CarThera
Bristol-Myers Squibb
Conditions:
Glioblastoma
Gliosarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 nov...
Detailed Description
Eligible patients will undergo craniotomy for tumor resection. During the tumor resection and when possible, an initial low dose of albumin-bound paclitaxel will be given following sonication. In sele...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of Isocitrate Dehydrogenase 1 (IDH1) wild-type glioblastoma on pathology from initial surgery (e.g. IDH R132H neg); morphologic or molecular determination of grade 4
- Ability to undergo contrast-enhanced MRI
- Radiographic evidence of tumor recurrence/progression after failure of 1 - 2 lines of prior therapy
- Measurable or evaluable disease
- Measurable: contrast-enhancement (bidirectional diameters ≥ 1cm) on MRI
- Non-measurable/evaluable: contrast-enhancement diameters \< 1 cm
- Maximal tumor diameter pre-surgery ≤ 70 mm on T1wMRI
- Candidate for at least partial surgical resection
- Greater 12 weeks from completion of radiation therapy
- Age ≥ 18 years
- If receiving dexamethasone for mass effect, a stable daily dose of dexamethasone at \< 6 mg within 7 days of registration, or if dexamethasone dose is decreasing, average daily dose of \< 6 mg in the 7 days prior to registration. Patients on dexamethasone for reasons other than mass effect may still be enrolled.
- WHO performance status ≤ 2 (equivalent to Karnofsky Performance Status (KPS) of ≥70)
- Adequate hepatic, renal and bone marrow function, documented with normal laboratory values or no more than grade 1 outside the norm performed within 14 days prior to registration
- For patients with a childbearing potential
- Negative pregnancy test within 14 days prior to registration
- Agreement to use adequate contraception for the duration of study participation, and for 3 and 6 months after the last dose of albumin-bound paclitaxel for men and women of childbearing potential, respectively.
- Have the ability to understand and the willingness to sign a written informed consent prior to registration on study
- Be willing and able to comply with the protocol for the duration of the study
- Provide written, signed and dated informed consent prior to study registration. NOTE: no study-specific screening procedures may be performed until written consent has been obtained
Exclusion
- Have multifocal disease that cannot be encompassed in the ultrasound fields:
- e.g. \> 70-mm apart
- tumor located in the posterior fossa
- Patients at risk of cranial wound dehiscence
- Have uncontrolled epilepsy or require treatment with enzyme-inducing antiepileptics
- Have clinical evidence of peripheral neuropathy on examination
- Have received any other investigational agents within 4 weeks of registration
- Have received prior therapy with or have history of allergic reactions attributed to compounds of similar chemical or biologic composition to paclitaxel or carboplatin
- Medical contraindications to Abraxane® or carboplatin
- Have an uncontrolled intercurrent illness
- Are pregnant or nursing
- Have a history of active malignancy within 3 years prior to registration.
- Have a known history of hypersensitivity reactions to perflutren lipid microsphere components or to any of the inactive ingredients in Definity® (the FDA-approved ultrasound contrast agent to be used in this study)
- Patients with coils, clips, shunts, intravascular stents, and/or non-removable wafer, non resorbable dura substitute, or reservoirs.
- Patients with medical need to continue antiplatelet therapy.
- Patients with known significant cardiac disease, known to have right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure \> 90 mmHg), uncontrolled systemic hypertension, or adult respiratory distress syndrome (patient at risk for microbubble reaction).
- Patients with impaired thermo-regulation or temperature sensation (due to device)
Key Trial Info
Start Date :
October 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2025
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT04528680
Start Date
October 29 2020
End Date
November 30 2025
Last Update
July 31 2025
Active Locations (1)
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1
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611