Intraarterial carboplatin combined with radiotherapy for relapsing glioblastoma

A Phase II Study in Relapsing Glioblastoma of Intraarterial Concurrent Chemoradiation Therapy Using IA Carboplatin

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.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Université de Sherbrooke (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Sherbrooke, Quebec)
• Trial ID: NCT03672721 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of intraarterial (IA) carboplatin in combination with radiotherapy for patients with relapsing glioblastoma multiforme (GBM). The study aims to improve treatment outcomes by bypassing the blood-brain barrier, which limits the effectiveness of traditional chemotherapy. Patients will undergo surgery for tumor reduction and sample collection, followed by concurrent IA carboplatin and radiation therapy. The trial is designed to assess the safety and efficacy of this novel approach in enhancing progression-free survival and overall survival in this challenging patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and over with a histological diagnosis of glioblastoma multiforme who have experienced radiological progression after standard treatment.

Not a fit: Patients who have not been previously treated with the Stupp protocol or those with impaired organ function may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for patients with relapsing glioblastoma.

How similar studies have performed: While this approach is novel in combining IA delivery with radiation, previous studies have shown promise in using intraarterial chemotherapy for brain tumors.

Eligibility 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, and progressing. 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. 18 of age and over
5. Performance status: Karnofsky 60-100%
6. Haematopoietic parameters at enrolment:

   * Platelet counts \> 100,000/mm\^3
   * Hemoglobin \> 8 g/dL
   * Absolute neutrophil count \> 1,500/mm\^3
   * No impaired bone marrow function
7. Hepatic parameters at enrolment:

   * Bilirubin ≤ 2 times normal value
   * AST and ALT ≤ 2 times upper limit of normal (ULN) Alkaline phosphatase ≤ 2 times ULN (unless attributed to tumor)
   * No impaired hepatic function
8. Renal parameters at enrollment:

   * No impaired renal function
   * Creatinine no greater than 1.5 fold of the normal value
   * Creatinine clearance \> 30 ml/min.
9. Normal ECG
10. Written informed consent obtained
11. Patient should be either sterile or else use a contraceptive strategy (for at least 2 months prior to study accrual).

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Exclusion Criteria:

1. Presence of a severe psychiatric or medical condition that would interfere with treatment administration or study enrolment.
2. Presence of an active auto-immune disease.
3. Occurrence of another malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
4. Pregnancy (as objectivated by a positive b-HCG) or actively nursing
5. 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 — Crc-Chus
• Study coordinator: David Fortin, MD

Conditions Glioblastoma Multiforme; Relapse