NanoTherm In Adjuvant Therapy of Glioblastoma Multiforme

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.

Conditions

• Glioblastoma Multiforme

Interventions

DEVICE

NanoTherm therapy

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

PROCEDURE

Glioma Resection

Removal of brain tumor - gross total ressection

RADIATION

radiotherapy 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.

DRUG

chemotherapy 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.

Sponsors & Collaborators

• MagForce USA

  collaborator INDUSTRY

• Poznan University of Medical Sciences

  lead OTHER

Principal Investigators

• Slawomir Michalak, Prof. · Poznan University of Medical Sciences

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-01

Primary Completion

2027-02-01

Completion

2027-09-01

Countries

• Poland

Study Locations