RecruitingPhase 2NCT06356883

Intraarterial Carboplatin + Caelyx vs Intraarterial Carboplatin + Etoposide Phosphate for Progressing Glioblastoma

A Randomized Phase II Study on Intraarterial Carboplatin Combined With Caelyx Compared to Intraarterial Carboplatin Combined With Etoposide Phosphate for Progressing Glioblastoma at First or Second Relapse


Sponsor

Université de Sherbrooke

Enrollment

120 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two treatment combinations delivered directly into the arteries of the brain for patients with glioblastoma (an aggressive brain tumor) that has come back after standard treatment. Both options combine a chemotherapy drug (carboplatin) with either Caelyx (a specialized form of doxorubicin) or etoposide phosphate, given via intraarterial infusion. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of glioblastoma - Your tumor has progressed on MRI after completing standard radiation and temozolomide chemotherapy - Your overall physical ability is moderate to good (Karnofsky score 60–100%) - Your blood counts, liver function, and kidney function meet the required thresholds - You are willing to use contraception during the study **You may NOT be eligible if...** - You have a severe psychiatric condition or active autoimmune disease - You have had prior intraarterial chemotherapy - Your organ function (blood, liver, kidneys) is inadequate for treatment - You have an abnormal heart rhythm (ECG) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIA Carboplatin + IA Caelyx

Intraarterial infusion of carboplatin combined with liposomal doxorubicin

DRUGIA Carboplatin + IA Etoposide Phosphate

Intraarterial infusion of carboplatin combined with etoposide phosphate


Locations(1)

CHUS

Sherbrooke, Quebec, Canada

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NCT06356883


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