Local targeted therapy for recurrent glioblastoma using alpha emitter.

Medical Experiment - Assessment of Efficacy & Safety of Local, Targeted Therapy With Neuropeptide Labelled With Alpha Emitter [225Ac]Ac-DOTA-SP (TAT) as Supplementary Therapy in Glioma (WHO G3-G4) Progression

This study is testing a new targeted treatment for adults with recurrent high-grade gliomas to see if it can help them after standard therapies have failed.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 35 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Medical University of Warsaw (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 2 sites (Warsaw, Poland and 1 other locations)
• Trial ID: NCT06975332 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of a local targeted therapy using the alpha emitter [225Ac]Ac-DOTA-SP in patients with recurrent high-grade gliomas (WHO G3-G4) who have undergone standard treatments. The study focuses on patients aged 18-80 with specific MRI-defined tumor progression and aims to provide a novel treatment option for this challenging condition. It is an interventional study without a control group, initiated by the researcher, and seeks to address the pressing need for improved therapeutic strategies in glioma management.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with histologically confirmed recurrent WHO G3-G4 gliomas who have previously undergone standard treatments.

Not a fit: Patients with multifocal lesions or those requiring immediate surgical intervention may not benefit from this study.

Why it matters

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

How similar studies have performed: While targeted therapies have shown promise in other contexts, this specific approach using [225Ac]Ac-DOTA-SP is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

* age 18-80;
* histologically confirmed diffuse glioma (CNS WHO G3-G4);
* after standard treatment with biopsy or resection, radiotherapy and/or chemotherapy;
* tumour progression as defined by RANO 2.0 on MRI (hyperintense lesion on MRI or increase of maximal transverse diameter of tumour or increase on volumetric measurement, local progression by continuity in proximity of 4 cm to primary lesion after resection, stable lesion progression on MRI \>25% in time between two consecutive MRIs or any new lesion on MRI; to differentiate progression from pseudoprogression a biopsy may be needed, especially within 12 weeks from radiotherapy);
* unifocal lesion;
* after resection: tumour volume \<50 ml AND tumour tissue thickness on contrast-enhanced T1 MRI \<1 cm;
* after biopsy: tumour median diameter \<2 cm;
* functional state \>70 according to Karnofsky's performance scale (KPS);
* ability to give informed consent to participate in the study.

Exclusion criteria:

* necessity of urgent surgery (e.g., sudden increase in intracranial pressure);
* significant postoperative complications: e.g., Karnofsky's performance scale (KPS) \<70, wound infection, cerebrospinal fluid leak;
* ventricular shunt leak \>10% during a control patency test;
* open/communicating resection cavity;
* mass effect on CT scan or MRI with midline shift of more than 5 mm and/or nausea, vomiting, altered consciousness, or clinically significant papilledema;
* catheter obstruction;
* predicted life expectancy less than 3 months;
* patients without preserved logical-verbal contact or uncooperative;
* inability to provide informed, voluntary consent to participate in the study;
* patients participating in another medical experiment;
* patients who have taken any other investigational drug within 1 month of the first dose;
* prior treatment with \[225Ac\]Ac-DOTA-SP;
* breastfeeding or pregnancy;
* severe diseases of other organs that, in the opinion of the Investigator, significantly increase the risk of the procedure.

Where this trial is running

Warsaw, Poland and 1 other locations

• Department of Neurosurgery, Medical University of Warsaw, Banacha 1a — Warsaw, Poland, Poland (Recruiting)
• Department of Neurosurgery, National Instiute of Oncology, W.K. Roentgena 5 — Warsaw, Poland, Poland (Recruiting)

Study contacts

• Principal investigator: Przemysław Kunert, Professor — Department of Neurosurgery, Medical University of Warsaw, Poland
• Study coordinator: Przemysław Kunert, Professor

Conditions Glioblastoma; High-Grade Gliomas; Grade III Astrocytoma; Grade III Glioma; alpha emitter; glioblastoma recurrence; local therapy; 225-Ac