NCT06356883 Intraarterial Carboplatin + Caelyx vs Intraarterial Carboplatin + Etoposide Phosphate for Progressing Glioblastoma
| NCT ID | NCT06356883 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Université de Sherbrooke |
| Condition | Glioblastoma Multiforme |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-08 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 120 participants in total. It began in 2025-08 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The standard of care for glioblastoma (GBM) treatment involves maximal resection followed by concomitant radiotherapy and temozolomide. Progression-free survival (PFS) with this treatment is only 6.9 months and relapse is inevitable. At relapse, there is no consensus regarding the optimal therapeutic strategy. The rationale behind the fact that limited chemotherapy agents are available in the treatment of malignant gliomas is related to the blood-brain barrier (BBB), which impedes drug entry to the brain. Intraarterial (IA) chemotherapy allows to circumvent this. Using IA delivery of carboplatin, can produce responses in 70% of patients for a median PFS of 5 months. Median survival from study entry was 11 months, whereas the overall survival (OS) 23 months. How can the OS and PFS be improved? By combining chemotherapeutic agents with different mechanisms of action. Study design: In this phase II trial, treatment will be offered at relapse. Surgery will be performed for cytoreduction if it is warranted, followed with a combination IA carboplatin + IA Cealyx (liposomal doxorubicin) or IA carboplatin + IA etoposide phosphate. Toxicity will be assessed according to the NCIC common toxicity criteria. Treatment will consist in either IA carboplatin (400 mg/m\^2) + IA Cealyx (30 mg/m\^2) or IA carboplatin (400 mg/m\^2) + IA etoposide phosphate (400 mg/m\^2) every 4-6 weeks (1 cycle). Up to twelve cycles will be offered. Outcome measurements: Tumor response will be evaluated using the RANO criteria by magnetic resonance imaging monthly. Primary outcome will PFS and tumor response. Secondary outcome will include median OS, toxicity, quality of life (QOL), neurocognition (NC). Putting together these data will allow to correlate clinical and radiological response to QOL and NC.
Eligibility Criteria
Inclusion Criteria: 1. Histological diagnosis of glioblastoma multiforme. 2. Radiological progression on an MRI scan, according to the RANO criteria, in the context of a known glioblastoma multiforme, already treated with the Stupp protocol of combined radiotherapy-Temozolomide. This implies a measurable disease on MRI. 3. Prior radiotherapy and temozolomide, as per the Stupp protocol, no sooner than 4 weeks, is permitted. 4. Eighteen or more years of age. 5. Performance status: Karnofsky ranging from 60 to 100%. 6. Haematopoietic parameters at recruitment: * Platelet counts \> 100,000/mm3. * Hemoglobin \> 8 g/dL. * Absolute neutrophil count \> 1,500/mm3. 7. No impaired bone marrow function. 8. Hepatic parameters at recruitment: * Bilirubin ≤ 2 times normal value. * AST and ALT ≤ 2 times upper limit of normal (ULN). * Alkaline phosphatase ≤ 2 times ULN (unless attributed to the tumour). * No impaired hepatic function. 9. Renal parameters at recruitment: * No impaired renal function. * Creatinine no greater than 1.5 fold of the normal value. * Creatinine clearance \> 30 ml/min. 10. Normal ECG. 11. Written informed consent obtained. * Patients should be either sterile or else use a contraceptive strategy (for at least 2 months prior to study accruals). Exclusion Criteria: 1. Presence of a severe psychiatric or medical condition that would interfere with treatment administration or study recruitment. 2. Presence of an active autoimmune disease. 3. No prior cardiac disease within the past 5 years OR LVEF of at least 50% at baseline ultrasound. 4. Occurrence of another malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or in situ cervical carcinoma. 5. Pregnancy (as confirmed by a positive b-HCG) or actively nursing. 6. Presence of an uncontrolled systemic infection.
Contact & Investigator
David Fortin, MD
PRINCIPAL INVESTIGATOR
Estrie University Integrated Health and Social Services Center - University Hospital of Sherbrooke
Frequently Asked Questions
Who can join the NCT06356883 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Glioblastoma Multiforme. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06356883 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06356883 currently recruiting?
Yes, NCT06356883 is actively recruiting participants. Contact the research team at david.fortin@usherbrooke.ca for enrollment information.
Where is the NCT06356883 trial being conducted?
This trial is being conducted at Sherbrooke, Canada.
Who is sponsoring the NCT06356883 clinical trial?
NCT06356883 is sponsored by Université de Sherbrooke. The principal investigator is David Fortin, MD at Estrie University Integrated Health and Social Services Center - University Hospital of Sherbrooke. The trial plans to enroll 120 participants.
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