IA Carboplatin + Radiotherapy in Relapsing GBM

Launched by UNIVERSITÉ DE SHERBROOKE · Sep 10, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with relapsed glioblastoma multiforme (GBM), a type of brain cancer. After the standard treatments (surgery, radiation, and chemotherapy) are no longer effective, this trial explores using a combination of radiation therapy and a special method of delivering a chemotherapy drug called carboplatin directly into the arteries that supply the brain. The goal is to see if this combination can improve how long patients live without their disease getting worse and overall survival compared to previous treatments.

To participate in this trial, patients must be at least 18 years old and have a confirmed diagnosis of glioblastoma that has worsened despite prior treatment. They should also meet certain health criteria, such as having good overall health and blood test results. Participants will receive radiation and carboplatin treatments over several months, with regular check-ups to monitor their response to the therapy. Throughout the study, researchers will also assess the impact of the treatment on the patients' quality of life and cognitive function.

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, and progressing. 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. 18 of age and over
• • 5. Performance status: Karnofsky 60-100%
• 6. Haematopoietic parameters at enrolment:
• • Platelet counts \> 100,000/mm\^3
• • Hemoglobin \> 8 g/dL
• • Absolute neutrophil count \> 1,500/mm\^3
• • No impaired bone marrow function
• 7. Hepatic parameters at enrolment:
• • Bilirubin ≤ 2 times normal value
• • AST and ALT ≤ 2 times upper limit of normal (ULN) Alkaline phosphatase ≤ 2 times ULN (unless attributed to tumor)
• • No impaired hepatic function
• 8. Renal parameters at enrollment:
• • No impaired renal function
• • Creatinine no greater than 1.5 fold of the normal value
• • Creatinine clearance \> 30 ml/min.
• • 9. Normal ECG
• • 10. Written informed consent obtained
• • 11. Patient should be either sterile or else use a contraceptive strategy (for at least 2 months prior to study accrual).
• • -
• Exclusion Criteria:
• • 1. Presence of a severe psychiatric or medical condition that would interfere with treatment administration or study enrolment.
• • 2. Presence of an active auto-immune disease.
• • 3. Occurrence of another malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
• • 4. Pregnancy (as objectivated by a positive b-HCG) or actively nursing
• • 5. Presence of an uncontrolled systemic infection