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Brief Title: Sonocloud-9 in Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU or TMZ) in Recurrent GBM
Official Title: A Randomized, Open-label, Multicentric, Two-arm Pivotal Trial of SonoCloud-9 Combined With Carboplatin (CBDCA) vs Standard of Care Lomustine (CCNU) or Temozolomide (TMZ) in Patients Undergoing Planned Resection for First Recurrence Glioblastoma.
Study ID: NCT05902169
Brief Summary: 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 and specially developed to open the BBB in the area of and surrounding the tumour. The transient opening of the BBB allows more drugs to reach the brain tumour tissue. Carboplatin is a chemotherapy that is approved to treat different cancer types alone or in combination with other drugs, and has been used in the treatment of glioblastoma. Despite its proven efficacy in the laboratory on glioblastoma cells, carboplatin does not readily cross the BBB in humans. A clinical trial has shown that in combination with the SonoCloud-9, more carboplatin can reach the brain tumour tissue. The objective of the proposed trial is to show that the association - carboplatin with the SonoCloud-9 - will increase efficacy of the drug in patients with recurrent glioblastoma.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Northwestern University, Chicago, Illinois, United States
Indiana University Health, Indianapolis, Indiana, United States
NewYork-Presbyterian / Columbia University Irving Medical Center, New York, New York, United States
University of North Carolina, Chapel Hill, North Carolina, United States
Universitair Ziekenhuis Brussel, Brussel, , Belgium
Universitair Ziekenhuis Leuven, Leuven, , Belgium
CHU de Liège, Liège, , Belgium
Hôpital Neurologique Pierre Wertheimer, Bron, , France
Hôpital de La Timone, Marseille, , France
Hôpital de la Pitié-Salpêtrière, Paris, , France
Neurochirurgie uniklinik Köln, Köln, , Germany
Istituto Oncologico Veneto, Padua, , Italy
Erasmus Medisch Centrum (Erasmus MC), Rotterdam, , Netherlands
Hospital Universitario 12 de Octubre, Madrid, , Spain