Fact CheckerSign in

NCT06356883RecruitingPhase 2

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

A Randomized Phase II Study on Intraarterial Carboplatin Combined With Caelyx Compared to Intraarterial Carboplatin Combined With Etoposide Phosphate for Progressing Glioblastoma at First or Second Relapse

Source: ClinicalTrials.gov · Last updated 7 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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 phase II trial, treatment will be offered at relapse. Surgery will be performed for cytoreduction if it is warranted, followed with a combination IA carboplatin + IA Cealyx (liposomal doxorubicin) or IA carboplatin + IA etoposide phosphate. Toxicity will be assessed according to the NCIC common toxicity criteria. Treatment will consist in either IA carboplatin (400 mg/m\^2) + IA Cealyx (30 mg/m\^2) or IA carboplatin (400 mg/m\^2) + IA etoposide phosphate (400 mg/m\^2) every 4-6 weeks (1 cycle). Up to twelve cycles will be offered. Outcome measurements: Tumor response will be evaluated using the RANO criteria by magnetic resonance imaging monthly. Primary outcome will PFS and tumor response. Secondary outcome will include median OS, toxicity, quality of life (QOL), neurocognition (NC). Putting together these data will allow to correlate clinical and radiological response to QOL and NC.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
120 (estimated)
First submitted
19 Mar 2024
Start date
Aug 2025
Primary completion date
Apr 2027
Lead sponsor
Université de Sherbrooke
Diseases
Glioblastoma
NCT number
NCT06356883

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 120
  • From Aug 2025 to the primary completion date, Apr 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Presence of a severe psychiatric or medical condition that would interfere with treatment administration or study recruitment.
  • Presence of an active autoimmune disease.
  • Occurrence of another malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or in situ cervical carcinoma.
  • Presence of an uncontrolled systemic infection.

Lab values

  • No prior cardiac disease within the past 5 years OR LVEF of at least 50% at baseline ultrasound.

Other

  • Pregnancy (as confirmed by a positive b-HCG) or actively nursing.

Who the study is looking for

  • 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 measurable disease on MRI.
  • 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).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHUS
Coordinator of this site? Confirm its status		SherbrookeCanadaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.