Comparing two chemotherapy combinations for treating relapsed 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
This study is testing two different chemotherapy combinations to see if they can help people with relapsed glioblastoma live longer and feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Université de Sherbrooke Academic / other |
| Drugs / interventions | chemotherapy, doxorubicin, radiation, methotrexate |
| Locations | 1 site (Sherbrooke, Quebec) |
| Trial ID | NCT06356883 on ClinicalTrials.gov |
What this trial studies
This phase II trial investigates the effectiveness of intraarterial delivery of carboplatin combined with either Caelyx or Etoposide Phosphate in patients with relapsed glioblastoma multiforme. The study aims to improve progression-free survival and overall survival by utilizing a targeted delivery method that circumvents the blood-brain barrier. Eligible participants will have a confirmed diagnosis of glioblastoma and measurable disease progression after standard treatment. The trial will assess the response rates and survival outcomes of the two treatment combinations.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a histological diagnosis of glioblastoma multiforme who have experienced radiological progression after initial treatment.
Not a fit: Patients with significant comorbidities or those who have not previously received the standard Stupp protocol treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with relapsed glioblastoma, potentially improving survival rates.
How similar studies have performed: While intraarterial chemotherapy has shown promise in previous studies, this specific combination approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Sherbrooke, Quebec
- Chus — Sherbrooke, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: David Fortin, MD — Estrie University Integrated Health and Social Services Center - University Hospital of Sherbrooke
- Study coordinator: David Fortin, MD
- Email: david.fortin@usherbrooke.ca
- Phone: 819-346-1110
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.