OncoMatch/Clinical Trials/NCT06356883
Intraarterial Carboplatin + Caelyx vs Intraarterial Carboplatin + Etoposide Phosphate for Progressing Glioblastoma
Is NCT06356883 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including IA Carboplatin + IA Caelyx and IA Carboplatin + IA Etoposide Phosphate for glioblastoma multiforme.
Treatment: IA Carboplatin + IA Caelyx · IA Carboplatin + IA Etoposide Phosphate — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Performance status
KARNOFSKY 60–100
Prior therapy
Must have received: radiation therapy
already treated with the Stupp protocol of combined radiotherapy-Temozolomide
Must have received: cytotoxic chemotherapy (temozolomide)
already treated with the Stupp protocol of combined radiotherapy-Temozolomide
Lab requirements
Blood counts
Platelet counts > 100,000/mm3. Hemoglobin > 8 g/dL. Absolute neutrophil count > 1,500/mm3. No impaired bone marrow function.
Kidney function
No impaired renal function. Creatinine no greater than 1.5 fold of the normal value. Creatinine clearance > 30 ml/min.
Liver function
Bilirubin ≤ 2 times normal value; AST and ALT ≤ 2 times ULN; Alkaline phosphatase ≤ 2 times ULN (unless attributed to the tumour); No impaired hepatic function.
Cardiac function
Normal ECG. No prior cardiac disease within the past 5 years OR LVEF of at least 50% at baseline ultrasound.
Haematopoietic parameters at recruitment: Platelet counts > 100,000/mm3. Hemoglobin > 8 g/dL. Absolute neutrophil count > 1,500/mm3. No impaired bone marrow function. Hepatic parameters at recruitment: Bilirubin ≤ 2 times normal value. AST and ALT ≤ 2 times ULN. Alkaline phosphatase ≤ 2 times ULN (unless attributed to the tumour). No impaired hepatic function. Renal parameters at recruitment: No impaired renal function. Creatinine no greater than 1.5 fold of the normal value. Creatinine clearance > 30 ml/min. Normal ECG.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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