Comparing two chemotherapy combinations for treating relapsed glioblastoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Intraarterial carboplatin combined with radiotherapy for relapsing glioblastoma

  This study is testing if a new way of giving carboplatin along with radiation can help people with relapsing glioblastoma live longer and feel better.

  Recruiting Phase 1/2 Université de Sherbrooke · Sherbrooke, Quebec · NCT03672721

• How facial type relates to relapse after orthodontic treatment during retention

  This study tests whether people with different facial types have different patterns of tooth movement relapse after orthodontic treatment during the retention phase.

  Recruiting Postgraduate Institute of Dental Sciences Rohtak · Rohtak, Haryana · NCT07622277

• Can a multi-omics and AI model predict ABPA relapse within 1 year in adults?

  This study tests a machine learning model that uses multi-omics and clinical data to predict the 1-year relapse risk for adults with ABPA who are in a stable state.

  Recruiting Qianfoshan Hospital · Jinan, Shandong · NCT07611838

• Serplulimab plus second-line chemo/targeted therapy for early-relapse colorectal cancer after adjuvant therapy

  This trial tests whether adding serplulimab to standard second-line chemotherapy plus targeted therapy helps people whose colorectal cancer came back early after adjuvant treatment.

  Recruiting Phase 2 Fudan University · Shanghai · NCT07604909

• How iNKT immune cells after allogeneic stem cell transplant relate to transplant complications

  This study tests whether levels of invariant NKT cells in the blood after an allogeneic stem cell transplant can be linked to complications like GvHD, infections, or relapse in patients with AML.

  Recruiting University Hospital Pilsen · Pilsen, Czechia · NCT07570407

• LMP744 (an indenoisoquinolone) for people with recurrent glioblastoma

  This trial will test whether the drug LMP744 can shrink tumors or slow progression in adults whose glioblastoma has returned after prior treatment.

  Recruiting Phase 1/2 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07416188

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.