Actively Recruiting
Intraarterial Carboplatin + Caelyx vs Intraarterial Carboplatin + Etoposide Phosphate for Progressing Glioblastoma
Led by Université de Sherbrooke · Updated on 2025-08-07
120
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intraarterial Carboplatin + Caelyx vs Intraarterial Carboplatin + Etoposide Phosphate for Progressing Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological diagnosis of glioblastoma multiforme
- Radiological progression on MRI scan per RANO criteria after Stupp protocol treatment
- Prior radiotherapy and temozolomide treatment at least 4 weeks before enrollment
- Age 18 years or older
- Karnofsky performance status between 60% and 100%
- Platelet count greater than 100,000/mm3
- Hemoglobin greater than 8 g/dL
- Absolute neutrophil count greater than 1,500/mm3
- No impaired bone marrow function
- Bilirubin level less than or equal to twice the normal value
- AST and ALT less than or equal to twice the upper limit of normal
- Alkaline phosphatase less than or equal to twice the upper limit of normal unless related to tumor
- No impaired hepatic function
- No impaired renal function
- Creatinine no greater than 1.5 times normal
- Creatinine clearance greater than 30 ml/min
- Normal ECG
- Written informed consent obtained
- Participants must be sterile or use contraception for at least 2 months before joining
You will not qualify if you...
- Severe psychiatric or medical condition interfering with treatment or study participation
- Active autoimmune disease
- Prior cardiac disease within past 5 years or left ventricular ejection fraction below 50%
- Another malignancy within past 5 years except certain treated skin cancers or cervical carcinoma in situ
- Pregnancy or actively nursing
- Uncontrolled systemic infection
AI-Screening
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Trial Site Locations
Total: 1 location
1
CHUS
Sherbrooke, Quebec, Canada, J1H 5N4
Actively Recruiting
Research Team
D
David Fortin, MD
CONTACT
M
Marie-Andrée Roy, Nurse
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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