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

Launched by UNIVERSITÉ DE SHERBROOKE · Apr 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two different combinations of chemotherapy treatments for patients with glioblastoma multiforme (GBM) who have experienced a relapse after initial treatment. Glioblastoma is a type of brain cancer that often comes back after the first round of treatment, which typically includes surgery, radiation, and a medication called temozolomide. The trial will explore whether using two different drugs alongside carboplatin, an existing chemotherapy drug, can improve survival and quality of life for patients. Participants will receive either carboplatin plus Caelyx (a specialized form of doxorubicin) or carboplatin plus etoposide phosphate, with treatment cycles occurring every 4 to 6 weeks.

To be eligible for this study, participants must be at least 18 years old and have been diagnosed with glioblastoma that has shown progression on MRI scans after receiving prior treatment. They should have sufficient blood counts and organ function, and they must provide informed consent to participate. Throughout the study, patients will undergo regular imaging tests to monitor their tumor response and will be assessed for quality of life and any side effects from the treatments. This trial aims to find better ways to manage this challenging condition and improve outcomes for those affected by it.

Gender

ALL

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.