Ultrasound-based Blood-brain Barrier Opening and Albumin-bound Paclitaxel and Carboplatin for Recurrent Glioblastoma

Korábbi kezelés

• Have uncontrolled epilepsy or require treatment with enzyme-inducing antiepileptics
• 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
• Have a history of active malignancy within 3 years prior to registration.
• 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.

Más betegség

• Have multifocal disease that cannot be encompassed in the ultrasound fields:
  • e.g. \> 70-mm apart
  • tumor located in the posterior fossa
• Have an uncontrolled intercurrent illness
• 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 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).

Egyéb

• Patients at risk of cranial wound dehiscence
• Have clinical evidence of peripheral neuropathy on examination
• Medical contraindications to Abraxane® or carboplatin
• Are pregnant or nursing
• Patients with impaired thermo-regulation or temperature sensation (due to device)

• 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