Using NanoTherm therapy for recurrent glioblastoma multiforme

Application of Nanoparticles for Cyclic Hyperthermia In Adjuvant Therapy of gLioblastoma Multiforme (ANCHIALE)

This study is testing a new treatment called NanoTherm therapy for people with recurrent glioblastoma multiforme to see if it can help them live longer and feel better alongside standard treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Poznan University of Medical Sciences (Academic / other)
• Drugs / interventions: immunotherapy, chemotherapy, radiation
• Locations: 1 site (Poznan)
• Trial ID: NCT06271421 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of NanoTherm therapy in patients with recurrent glioblastoma multiforme (GBM). Participants will undergo initial assessments to determine eligibility and will receive NanoTherm therapy alongside standard treatments like glioma resection, radiotherapy, and chemotherapy as per the Stupp protocol. The study aims to measure overall survival, progression-free survival, and the tolerance of the therapy in terms of side effects and quality of life. The trial is designed to provide insights into a novel treatment approach for a challenging condition.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years with recurrent glioblastoma multiforme who have failed standard treatment.

Not a fit: Patients with multiple tumor foci or significant tumor invasion into critical brain areas may not benefit from this study.

Why it matters

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

How similar studies have performed: While the use of hyperthermia in cancer treatment has been explored, the specific application of NanoTherm therapy in GBM is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. Recurrence of glioblastoma multiforme.
2. Age \> 18 years.
3. Informed written consent to participate in the study.
4. Karnofsky performance score ≥ 60.
5. Expected survival time \> 6 months.
6. Failure of standard treatment according to the Stupp protocol.
7. Cardio-respiratory fitness - allowing to stay for 60 minutes in a lying position in the field activator.

Exclusion Criteria:

1. Pregnant or breastfeeding women.
2. More than 3 foci of glioblastoma multiforme.
3. Tumor invasion of eloquent or motor areas.
4. Subependymal contrast enhancement in the adjacent brain ventricles.
5. Concurrent immunotherapy for glioblastoma.
6. Metal implants within ≤ 40 cm of the planned exposure field: metal dental fillings/restorations, cervical spine implants, metal elements left after previous craniotomies, metal elements used in osteosynthesis after orthopedically treated injuries, vascular ports with metal components.
7. Electronic implants: pacemakers, cardioverter defibrillators, cochlear implants, deep brain stimulation (DBS) electrodes.
8. Allergy/hypersensitivity to aminosilanes, iron oxide, acetic acid.
9. Planned or current treatment with electromagnetic field in the Optune®TTF system.
10. Claustrophobia not amenable to control.
11. Painful conditions, musculoskeletal system diseases that prevent staying in a lying position.

Where this trial is running

Poznan

• University Hospital — Poznan, Poland (Recruiting)

Study contacts

• Principal investigator: Slawomir Michalak, Prof. — Poznan University of Medical Sciences
• Study coordinator: Slawomir Michalak, Prof.

Conditions Glioblastoma Multiforme; glioblastoma; adjuvant therapy; hyperthermia; NanoTherm; GBM