RecruitingNot ApplicableNCT06271421

NanoTherm In Adjuvant Therapy of Glioblastoma Multiforme

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


Sponsor

Poznan University of Medical Sciences

Enrollment

100 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Glioblastoma multiforme (GBM), the most common and malignant primary brain tumor in adults is classified as a World Health Organisation (WHO) grade 4. Surgical removal of the tumor is the primary method of treatment. Unfortunately, because GBM is a disease of the entire brain, total resection is not possible. Therefore, the use of radiotherapy and/or chemotherapy is considered as Stupp protocol. Patients with recurrent GBM will be included in the ANCHIALE study. The goal of the trial is to evaluate the efficacy and tolerance of using the NanoTherm therapy system in recurrent GBM. The main questions it aims to answer are: 1. how NanoTherm therapy influences overall survival, and progression free survival; 2. what is the tolerance of NanoTherm therapy in terms of side effects (allergies, intracranial bleeding, infections, brain edema, increased intracranial pressure) and quality of life. Participants will undergo: * initial visit, considering the inclusion/exclusion criteria, neurological examination, and surveys regarding daily functioning and quality of life; * standard neurosurgical operation aimed, if possible, complete removal of the recurrent GBM and administration of NanoTherm ASI - a sterile suspension of iron oxide nanoparticles. A catheter will be implanted allowing for measurement of temperature during the first activation in the magnetic field; * between the 6th and 10th day after tumor resection, a standard computerized tomography (CT) scan of the head will be performed for routine postoperative evaluation; * after the first activation (10th day), the catheter will be removed; * subsequently, for 6 times, the patient will be subjected to the variable magnetic field of the NanoActivator® to induce hyperthermia - activations will be conducted on the 10th, 14th, 17th, 21st, 24th, and 28th day; * for up to 2 years post-procedure, a CT scan with an evaluation of treatment efficacy will be performed; * during follow-up visits for up to 2 years after the surgical procedure, a neurological examination, assessment of adverse symptoms, number of hospitalizations, number of medical visits, clinimetric assessment regarding quality of life, neurological deficit and degree of disability will be conducted. Researchers will compare NanoTherm group with patients undergoing Stupp protocol treatment for the abovementioned effects.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a heat-based therapy called NanoTherm — which uses tiny iron oxide particles injected into a brain tumor that are then heated using a magnetic field to destroy cancer cells — for people with recurrent glioblastoma, an aggressive brain cancer that has come back after standard treatment. **You may be eligible if...** - You are over 18 years old - Your glioblastoma has come back (recurred) after standard treatment - Your overall health score (Karnofsky score) is 60 or above - You are expected to survive at least 6 more months - You can lie still for 60 minutes during the procedure **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have more than 3 separate tumor areas - You have metal implants in certain parts of your body - You are currently receiving immunotherapy for your cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICENanoTherm therapy

Cyclic hyperthermia in patients with recurrent glioblastoma multiforme, who underwent implantation of iron oxide nanoparticles.

PROCEDUREGlioma Resection

Removal of brain tumor - gross total ressection

RADIATIONradiotherapy according to Stupp protocol

The total dose according to the Stupp protocol is 60 Gy and is administered in fractions of 2 Gy per day for 5 days (Monday to Friday) for 6 weeks.

DRUGchemotherapy according to Stupp protocol

Temozolomide is used during radiotherapy: 75 mg/m2 of body surface area per day for 7 days a week. After the completion of radiotherapy, temozolomide is used as adjuvant therapy - 6 cycles of 150-200 mg/m2 of body surface area for 5 days every 28 days.


Locations(1)

University Hospital

Poznan, Poland

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NCT06271421


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