Sonocloud-9 in Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU or TMZ) in Recurrent GBM

The brain is protected from any toxic or inflammatory molecule by the blood-brain barrier (BBB). This physical barrier is located at the level of the blood vessel walls. Because of these barrier properties, the blood vessels are also impermeable to the passage of therapeutic molecules from the blood to the brain. The development of effective treatments against glioblastoma is thus limited due to the BBB that prevents most drugs injected in the bloodstream from getting into brain tissue where the tumour is seated. The SonoCloud-9 (SC9) is an investigational device using ultrasound technology an

Trial Details

NCT ID
NCT05902169
Phase
PHASE3
Sponsor
CarThera
Status
RECRUITING
Cancer Type
Glioblastoma (GBM) Brain Cancer
Interventions
  • SonoCloud-9 (SC9)
  • Carboplatin
  • Lomustine
  • Temozolomide
Locations (sample)
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • San Francisco, California, United States|37.77493,-122.41942
  • Aurora, Colorado, United States|39.72943,-104.83192
  • Jacksonville, Florida, United States|30.33218,-81.65565
  • Miami, Florida, United States|25.77427,-80.19366

Key Eligibility Criteria

  • Histologically proven glioblastoma (WHO criteria 2021), absence of IDH mutation demonstrated by negative IDH1 R132H staining on Immunohistochemistry.
  • Patient must have received prior first line therapy that must have contained both:
  • Prior surgery or biopsy and standard fractionated radiotherapy (1.8-2 Gy/fraction, \>56 Gy\<66 Gy) or hypofractionated radiotherapy (15 x 2.66 Gy o…
  • One line of maintenance chemotherapy and/or immune- or biological therapy, (with or without Tumor-Treating Fields)

For full eligibility, visit ClinicalTrials.gov.

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