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Compares treatment options for Glioblastoma Multiforme
Official title Intraarterial Carboplatin + Caelyx vs Intraarterial Carboplatin + Etoposide Phosphate for Progressing Glioblastoma
ClinicalTrials.gov ID: NCT06356883
What this study is testing
What is IA Carboplatin + IA Caelyx?
IA Carboplatin + IA Caelyx is an investigational medicine, given as a monthly infusion into a vein, being studied as a potential treatment for glioblastoma multiforme.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histological diagnosis of glioblastoma multiforme.
- Radiological progression on an MRI scan, according to the RANO criteria, in the context of a known glioblastoma multiforme, already treated with the...
- Prior radiotherapy and temozolomide, as per the Stupp protocol, no sooner than 4 weeks, is permitted.
- Eighteen or more years of age.
- Performance status: Karnofsky ranging from 60 to 100%.
You likely can't join if
- Presence of a severe psychiatric or medical condition that would interfere with treatment administration or study recruitment.
- Presence of an active autoimmune disease.
- No prior cardiac disease within the past 5 years OR LVEF of at least 50% at baseline ultrasound.
- Occurrence of another malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or in situ cervical...
- Pregnancy (as confirmed by a positive b-HCG) or actively nursing.
- Presence of an uncontrolled systemic infection.
See the full eligibility criteria
- Histological diagnosis of glioblastoma multiforme.
- 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...
- Prior radiotherapy and temozolomide, as per the Stupp protocol, no sooner than 4 weeks, is permitted.
- Eighteen or more years of age.
- Performance status: Karnofsky ranging from 60 to 100%.
- Haematopoietic parameters at recruitment:
- Platelet counts \> 100,000/mm3.
- Hemoglobin \> 8 g/dL.
- Absolute neutrophil count \> 1,500/mm3.
- No impaired bone marrow function.
- 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.
- Renal parameters at recruitment:
- No impaired renal function.
- Creatinine no greater than 1.5 fold of the normal value.
- Creatinine clearance \> 30 ml/min.
- Normal ECG.
- Written informed consent obtained.
- Patients should be either sterile or else use a contraceptive strategy (for at least 2 months prior to study accruals).
- Presence of a severe psychiatric or medical condition that would interfere with treatment administration or study recruitment.
- Presence of an active autoimmune disease.
- No prior cardiac disease within the past 5 years OR LVEF of at least 50% at baseline ultrasound.
- Occurrence of another malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or in situ cervical carcinoma.
- Pregnancy (as confirmed by a positive b-HCG) or actively nursing.
- Presence of an uncontrolled systemic infection.
The study team makes the final eligibility decision.
Where it's taking place
- Sherbrooke, Quebec, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sherbrooke, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.