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.
K
Kathryn Nevel
Primary Investigator
Enrolling By Invitation
18-100 years
All
Phase
3
2 participants needed
2 Locations
Brief description of study
What is the purpose of this study?
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.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632
Detailed description of study
What happens during the study?
Experimental: Experimental Arm: SonoCloud-9 Ultrasound + Carboplatin
The SonoCloud-9 (SC9) device will be implanted in the skull bone window upon completion of tumor resection and routine craniotomy. Carboplatin (CBDCA) will be administered intravenously prior to sonication. The CBDCA/SC9 treatment will be repeated every 3 weeks (depending on patient's tolerability) until disease progression or as clinically indicated. Administration of up to 7 cycles is planned.
Active Comparator: Control Arm: SoC single agent chemotherapy TMZ or CCNU
Standard of Care (SoC) treatment with either temozolomide (TMZ) or lomustine (CCNU).
Standard TMZ chemotherapy as a single oral dose every 4 weeks for up to 6 cycles.
Standard CCNU chemotherapy as a single oral dose every 6 weeks for up to 4 cycles.
The SonoCloud-9 (SC9) device will be implanted in the skull bone window upon completion of tumor resection and routine craniotomy. Carboplatin (CBDCA) will be administered intravenously prior to sonication. The CBDCA/SC9 treatment will be repeated every 3 weeks (depending on patient's tolerability) until disease progression or as clinically indicated. Administration of up to 7 cycles is planned.
Active Comparator: Control Arm: SoC single agent chemotherapy TMZ or CCNU
Standard of Care (SoC) treatment with either temozolomide (TMZ) or lomustine (CCNU).
Standard TMZ chemotherapy as a single oral dose every 4 weeks for up to 6 cycles.
Standard CCNU chemotherapy as a single oral dose every 6 weeks for up to 4 cycles.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Glioblastoma
-
Age: Between 18 Years - 100 Years
-
Gender: All
Inclusion 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 or similar regimen)
- One line of maintenance chemotherapy and/or immune- or biological therapy, (with or without Tumor-Treating Fields)
- First, unequivocal disease progression with
- measurable tumor (>100 mm2 or 1 cm3, based on RANO criteria) documented (e.g., increase of 25% in tumor diameter) on MRI performed within 14 days of inclusion and,
- interval of a minimum of 12 weeks since the completion of prior radiotherapy, unless there is a new lesion outside the radiation field or unequivocal evidence of viable tumor on histopathological sampling
- Patient is candidate for craniotomy and at least 50% resection of enhancing region
- Maximal enhancing tumor diameter prior to inclusion ≤ 5 cm on T1w. (In case of planned lobectomy, post operative peritumoral brain or residual size ≤5 cm)
- WHO performance status ≤ 2 (equivalent to Karnofsky Performance Status (KPS) ≥ 70)
- Age ≥ 18 years
- Participant must be recovered from acute toxic effects (<grade 2) of all prior anticancer therapy. Interval since last therapy to presumed date of surgery of at least:
- ≥ 4 weeks or 5 half-lives (whichever is shorter) for
- Cytotoxic
- Other small chemical entity (e.g., targeted therapy)
- For biologics (e.g., antibodies, except bevacizumab)
- ≥ 6 weeks of prior bevacizumab
- Adequate hematologic, hepatic, and renal laboratory values within 14 days of inclusion i.e.:
- Hemoglobin ≥ 10 g/dL, platelets ≥ 100,000/mm3, neutrophils ≥ 1500/mm3.
- Liver function test with ≤ grade 1 alterations, except if due to antiepileptic drug therapy or isolated increased bilirubin due to Gilbert syndrome
- Estimated glomerular filtration rate (eGFR) of at least 60 mL/min/1.73 m2 using Cockcroft Gault formula
- Patient able to understand clinical trial information and willing to provide signed and informed consent
- Patient of childbearing potential must have a negative pregnancy test within 14 days of inclusion and must agree to use a medically-acceptable method of birth control during the treatment period and, if randomized in the experimental arm, for at least 1 month after the last cycle of carboplatin
- A male patient must agree to use condoms during the treatment period and, if randomized in the experimental arm, for at least 3 months after the last cycle of carboplatin; the patient must also refrain from donating sperm during this period.
- Patient must be a beneficiary of a health plan that covers routine patient care costs. Patient must be a beneficiary of or affiliated with a social security scheme (according to country-specific requirements)
Updated on
01 Aug 2024.
Study ID: NEUR-CARTHERA-SONOBIRD, 21560
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