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Compares treatment options for Glioblastoma
Official title Sonocloud-9 in Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU or TMZ) in Recurrent GBM
ClinicalTrials.gov ID: NCT05902169
What this study is testing
What is Carboplatin?
Carboplatin is an investigational medicine, being studied as a potential treatment for glioblastoma.
Also referred to as CycloButane DiCarboxylic Acid (CBDCA).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- One line of maintenance chemotherapy and/or immune- or biological therapy, (with or without Tumor-Treating Fields)
- First, unequivocal disease progression with
See the full eligibility criteria
Who can join
- 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 assigned by...
- A male patient must agree to use condoms during the treatment period and, if assigned by chance in the experimental arm, for at least 3 months after the last cycle of carboplatin; the patient must also refrain from...
- 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) Non-
- Multifocal enhancing tumor on T1w (unless all localized in a 5 cm diameter area)
- Posterior fossa tumor
- Known BRAF/ NTKR mutated patients
- Patient at risk of surgery site infection (e.g., 2 or more previous craniotomies/neurosurgery within the last 3 months, poor skin condition, and/or previously infected surgical field, or any other condition that is of...
- Patient treated at high, stable -or average- dose of corticosteroids (≥ 6 mg/day dexamethasone or equivalent) in the 7 days prior to inclusion. Patients on dexamethasone for reasons other than mass effect may still be...
- Contra-indication to carboplatin, CCNU or TMZ
- Known history of hypersensitivity reactions to perflutren lipid microsphere components or to any of the inactive ingredients in ultrasound resonator
- Patient has received bevacizumab for other reasons (such as tumor progression) than treating edema
- Peripheral neuropathy or neuropathy ≥ grade 2
- Uncontrolled epilepsy or evidence of intracranial pressure
- Patient with known intracranial aneurism or having presented intra-tumor significant spontaneous hemorrhage
- Patient with unremovable coils, clips, shunts, intravascular stents, and/or wafer, or reservoirs
- Patient with medical need to be on continued anti-platelet aggregation therapy and/or anticoagulation. Patients for whom anticoagulation/platelet aggregation can be temporarily interrupted may be eligible after...
- Patient receiving enzyme-inducing antiepileptic drugs (namely phenytoin, carbamazepine and derivatives, phenobarbital), unless switched on another antiepileptic regimen
- History of other malignancy within 3 years prior to study start with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma, non-melanomatous skin cancer or carcinoma in situ of the uterine...
- Patient with known or suspected active or chronic infections
- Patient with known significant cardiac disease, known to have right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure \> 90 mm Hg), uncontrolled systemic hypertension, or acute respiratory...
- Known sensitivity/allergy to gadolinium, or other intravascular contrast agents
- Patient with impaired thermo-regulation or temperature sensation
- Pregnant, or breastfeeding patient
- Any other serious patient medical or psychological condition that may interfere with adequate and safe delivery of treatment and care (e.g., positive human immunodeficiency virus [HIV] status, potential blood-borne...
- Patients under guardianship, curatorship, under legal protection or deprived of liberty by an administrative or judicial decision Exclusion Criterion: Occurrence of any major medical illnesses or impairments that in the...
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- San Francisco, California, United States
- Aurora, Colorado, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- Baltimore, Maryland, United States
- Rochester, Minnesota, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Hershey, Pennsylvania, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
- Innsbruck, Austria
- Brussels, Belgium
- Leuven, Belgium
+ 26 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; San Francisco, California, United States; Aurora, Colorado, United States; Jacksonville, Florida, United States; Miami, Florida, United States; Tampa, Florida, United States and 40 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.