Glioblastoma Multiforme study: IA Carboplatin + IA Caelyx
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?
This is an investigational combination of two chemotherapy drugs being studied as a potential treatment for glioblastoma multiforme. It is designed to be infused directly into the arteries leading to the brain to help the drugs reach the tumor area more effectively.
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
- This study aims to find out which of two drug mixtures works better to stop the cancer from growing and how long patients live.
- Who it's for
- People with glioblastoma (a type of brain cancer) that has returned after previous treatment.
- What's involved
- Participants receive chemotherapy drugs directly into an artery in the brain. They may also have surgery to remove some of the tumor. Doctors check the brain with MRI scans every month.
- Time commitment
- Treatment happens every 4 to 6 weeks for up to 12 cycles, with monthly scans to monitor progress.
- 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.
- 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%.
- Platelet counts \> 100,000/mm3.
- Hemoglobin \> 8 g/dL.
- Absolute neutrophil count \> 1,500/mm3.
- No impaired bone marrow function.
- 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.
- 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 is enrolling
- Sherbrooke, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, but 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?
This study is enrolling now at Sherbrooke, Quebec, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.