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

RecruitingPhase 2Ages 18 Years - anyAllUniversité de Sherbrooke
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • IA Carboplatin + IA Caelyx
  • IA Carboplatin + IA Etoposide Phosphate
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Where

1 site
CHUS
Sherbrooke, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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