Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06271421
Status:
RECRUITING
Last Update Posted:
2024-02-26
First Post:
2024-02-14
Brief Title:
NanoTherm In Adjuvant Therapy of Glioblastoma Multiforme
Sponsor:
Poznan University of Medical Sciences
Organization:
Poznan University of Medical Sciences
Study Overview
Official Title:
Application of Nanoparticles for Cyclic Hyperthermia In Adjuvant Therapy of gLioblastoma Multiforme ANCHIALE
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ANCHIALE
Brief 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 andor 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 inclusionexclusion 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
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 inclusionexclusion 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
Detailed Description:
Glioblastoma multiforme GBM is the most frequent glial tumor glioma The epidemiology of brain gliomas depends on many factors such as age gender genetics environment and lifestyle
According to statistics in developed countries brain gliomas account for about 2 of all tumors In the USA there are approximately 12000 new cases of brain gliomas annually and in Europe there are about 25000 The average age of individuals diagnosed with brain gliomas is 64 years although they can occur in all age groups However the majority of cases are diagnosed in individuals between 45 and 70 years of age The global incidence rate is 37100000 for men and 26100000 for women A higher incidence rate is observed in highly industrialized countries It is estimated that gliomas account for 30 to 40 of all intracranial tumors Approximately 50 of adult gliomas are the most malignant form - Glioblastoma multiforme G4
In 2009 1444 new cases of malignant brain tumors were recorded in men and 1362 in women in Poland Men have a slightly higher risk of developing brain gliomas than women The presence of genetic and hereditary factors including mutations in genes related to DNA repair and cell cycle control increases the risk of developing gliomas Risk factors for the development of gliomas include exposure to ionizing radiation and viral infections cytomegalovirus smoking alcohol abuse overweight lack of physical activity as well as exposure to certain chemicals such as pesticides and solvents
Recommendations for the treatment of Glioblastoma multiforme include
Surgical removal of the tumor as the primary method of treatment Unfortunately considering the fact that Glioblastoma multiforme is a disease of the entire brain complete tumor resection is not possible Therefore the use of radiotherapy andor chemotherapy is considered This treatment is used according to the protocol published by Stupp in 2005
Radiotherapy Radiotherapy is used to destroy the remaining tumor cells after the tumor removal It can be used after surgery or as a standalone treatment especially in cases where the tumor cannot be surgically removed 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
Chemotherapy In the Stupp protocol temozolomide is used during radiotherapy 75 mgm2 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 mgm2 of body surface area for 5 days every 28 days
However the clinical effects of using the Stupp protocol are not fully satisfactory The two-year survival rate after the full Stupp protocol radio- and chemotherapy is 265 of patients and after using only radiotherapy it is 104 of patients
Supportive treatment methods used in the treatment of Glioblastoma multiforme so far include thermotherapy - hyperthermia and nanotherapy
Hyperthermia involves
the use of elevated temperature to increase the effectiveness of radio- and chemotherapy
thermoablation in which the use of high temperatures - above 45C - causes direct damage to tumor cells
magnetic hyperthermia MHT eg NanoTherm Therapy NTT which has been registered in Europe as a method of treating Glioblastoma multiforme in cases of tumor recurrence Nanotherapy uses magnetic nanoparticles MNP which are used in diagnostic and therapeutic procedures
Hyperthermia and thermotherapy have been treatment methods studied in cancer patients and magnetic hyperthermia induced using nanoparticles is becoming the subject of increasingly advanced research
In a phase III study the use of tumor-treating fields TTF was evaluated as a first-line therapy in patients with Glioblastoma multiforme Low-power electromagnetic fields using long waves are directed at the tumor area using external electrodes According to the report from the Institute for Quality and Efficiency in Health Care IQWiG this method resulted in a 5-month extension of the overall survival of patients with Glioblastoma multiforme compared to patients treated with temozolomide and the tolerance of the treatment was acceptable
On the other hand NanoTherm therapy represents a promising form of thermotherapy leading to an extension of survival especially in cases of Glioblastoma multiforme recurrence In the study by Maier-Hauff et al it was shown that the average overall survival of patients undergoing NanoTherm therapy after recurrence was 134 months which was longer P001 than in patients treated according to the Stupp protocol 62 months The overall survival after the initial diagnosis of Glioblastoma multiforme was also longer 232 versus 146 months P001 The benefit observed in both groups of patients was attributed to the use of NanoTherm therapy
Therefore among the sought-after new methods of treating Glioblastoma multiforme that could increase the effectiveness of the current treatment NanoTherm therapy is a procedure that significantly increases the survival and quality of life of patients For this reason it is planned to conduct this study the aim of which is to determine the effectiveness and tolerance of using nanoparticles in cyclic hyperthermia as adjuvant therapy in patients with Glioblastoma multiforme
The main goal of the treatment for each patient with Glioblastoma multiforme is to prolong survival time and improve the quality of life According to the literature the median overall survival of these patients is 9 - 12 months
Patients with recurrent glioblastoma multiforme WHO G4 will be included in the ANCHIALE study
Study Objective
The aim of the ANCHIALE study is to prepare a registry that allows for the evaluation of the efficacy and tolerance of using the NanoTherm therapy system in cases of recurrent glioblastoma multiforme
Study Principles
During the initial visit a qualification for treatment will be conducted taking into account the inclusion and exclusion criteria ie indications and contraindications for the NanoTherm therapy system Additionally an interview neurological examination and surveys regarding daily functioning and quality of life will be conducted
After qualifying a patient for the study he or she will undergo standard neurosurgical operation aimed at partial or if possible complete removal of the recurrent brain tumor Then in the place of the removed tumor NanoTherm ASI will be administered in a quantity of either 112 or 335 mgml of iron particles This is a sterile suspension of iron oxide nanoparticles in sterile water characterized by a high specific ability to absorb heat associated with its superparamagnetic properties At the site where the thickest layer of nanoparticles NanoTherm ASI is applied a catheter will be implanted allowing for measurement and control of temperature during the first activation in the magnetic field of the NanoActivator
Between the 6th and 10th day after the neurosurgical procedure a standard computerized tomography CT scan of the head will be performed for routine postoperative evaluation
After the first activation 10th day post-implantation of NanoTherm ASI the catheter will be removed Subsequently cyclically for 6 times the patient will be subjected to the variable magnetic field of the NanoActivator to induce hyperthermia ie increase the temperature of the site after the removed tumor and the surrounding tissues Activations will be conducted on the 10th 14th 17th 21st 24th and 28th day The heat released by the nanoparticles NanoTherm ASI into the surrounding tissue causes destruction or damage to the cells of the glioblastoma multiforme hyperthermia effect increasing their susceptibility to radiotherapy and chemotherapy
The patient will then be subjected to detailed observation for 2 years Observation will include visits conducted on the 60th 90th 150th 210th 270th and 360th day after surgery and then every 3 months up to 2 years post-procedure
On the 6th - 10th 90th 150th 210th 270th and 360th day after surgery and then every 3 months up to 2 years post-procedure a CT scan with an evaluation of treatment efficacy will be performed The treatment effects on CT will be analyzed using RANO Response Assessment in Neuro-oncology scale
During follow-up visits on the 60th 90th 150th 210th 270th and 360th day and then every 3 months up to 2 years after the surgical procedure a neurological examination assessment of adverse symptoms number of potential hospitalizations number of medical visits clinimetric assessment regarding quality of life EuroQuality of Life-5 dimensions 5- levels EQ-5D-5L Neurologic Assessment in Neuro-Oncology NanoScale 2 and clinimetric assessment regarding neurological deficit and degree of disability will be conducted modified Rankin scale Barthel index
The results from NanoTherm group will be compared to patients undergoing standard neurosurgical treatment for the abovementioned effects
According to statistics in developed countries brain gliomas account for about 2 of all tumors In the USA there are approximately 12000 new cases of brain gliomas annually and in Europe there are about 25000 The average age of individuals diagnosed with brain gliomas is 64 years although they can occur in all age groups However the majority of cases are diagnosed in individuals between 45 and 70 years of age The global incidence rate is 37100000 for men and 26100000 for women A higher incidence rate is observed in highly industrialized countries It is estimated that gliomas account for 30 to 40 of all intracranial tumors Approximately 50 of adult gliomas are the most malignant form - Glioblastoma multiforme G4
In 2009 1444 new cases of malignant brain tumors were recorded in men and 1362 in women in Poland Men have a slightly higher risk of developing brain gliomas than women The presence of genetic and hereditary factors including mutations in genes related to DNA repair and cell cycle control increases the risk of developing gliomas Risk factors for the development of gliomas include exposure to ionizing radiation and viral infections cytomegalovirus smoking alcohol abuse overweight lack of physical activity as well as exposure to certain chemicals such as pesticides and solvents
Recommendations for the treatment of Glioblastoma multiforme include
Surgical removal of the tumor as the primary method of treatment Unfortunately considering the fact that Glioblastoma multiforme is a disease of the entire brain complete tumor resection is not possible Therefore the use of radiotherapy andor chemotherapy is considered This treatment is used according to the protocol published by Stupp in 2005
Radiotherapy Radiotherapy is used to destroy the remaining tumor cells after the tumor removal It can be used after surgery or as a standalone treatment especially in cases where the tumor cannot be surgically removed 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
Chemotherapy In the Stupp protocol temozolomide is used during radiotherapy 75 mgm2 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 mgm2 of body surface area for 5 days every 28 days
However the clinical effects of using the Stupp protocol are not fully satisfactory The two-year survival rate after the full Stupp protocol radio- and chemotherapy is 265 of patients and after using only radiotherapy it is 104 of patients
Supportive treatment methods used in the treatment of Glioblastoma multiforme so far include thermotherapy - hyperthermia and nanotherapy
Hyperthermia involves
the use of elevated temperature to increase the effectiveness of radio- and chemotherapy
thermoablation in which the use of high temperatures - above 45C - causes direct damage to tumor cells
magnetic hyperthermia MHT eg NanoTherm Therapy NTT which has been registered in Europe as a method of treating Glioblastoma multiforme in cases of tumor recurrence Nanotherapy uses magnetic nanoparticles MNP which are used in diagnostic and therapeutic procedures
Hyperthermia and thermotherapy have been treatment methods studied in cancer patients and magnetic hyperthermia induced using nanoparticles is becoming the subject of increasingly advanced research
In a phase III study the use of tumor-treating fields TTF was evaluated as a first-line therapy in patients with Glioblastoma multiforme Low-power electromagnetic fields using long waves are directed at the tumor area using external electrodes According to the report from the Institute for Quality and Efficiency in Health Care IQWiG this method resulted in a 5-month extension of the overall survival of patients with Glioblastoma multiforme compared to patients treated with temozolomide and the tolerance of the treatment was acceptable
On the other hand NanoTherm therapy represents a promising form of thermotherapy leading to an extension of survival especially in cases of Glioblastoma multiforme recurrence In the study by Maier-Hauff et al it was shown that the average overall survival of patients undergoing NanoTherm therapy after recurrence was 134 months which was longer P001 than in patients treated according to the Stupp protocol 62 months The overall survival after the initial diagnosis of Glioblastoma multiforme was also longer 232 versus 146 months P001 The benefit observed in both groups of patients was attributed to the use of NanoTherm therapy
Therefore among the sought-after new methods of treating Glioblastoma multiforme that could increase the effectiveness of the current treatment NanoTherm therapy is a procedure that significantly increases the survival and quality of life of patients For this reason it is planned to conduct this study the aim of which is to determine the effectiveness and tolerance of using nanoparticles in cyclic hyperthermia as adjuvant therapy in patients with Glioblastoma multiforme
The main goal of the treatment for each patient with Glioblastoma multiforme is to prolong survival time and improve the quality of life According to the literature the median overall survival of these patients is 9 - 12 months
Patients with recurrent glioblastoma multiforme WHO G4 will be included in the ANCHIALE study
Study Objective
The aim of the ANCHIALE study is to prepare a registry that allows for the evaluation of the efficacy and tolerance of using the NanoTherm therapy system in cases of recurrent glioblastoma multiforme
Study Principles
During the initial visit a qualification for treatment will be conducted taking into account the inclusion and exclusion criteria ie indications and contraindications for the NanoTherm therapy system Additionally an interview neurological examination and surveys regarding daily functioning and quality of life will be conducted
After qualifying a patient for the study he or she will undergo standard neurosurgical operation aimed at partial or if possible complete removal of the recurrent brain tumor Then in the place of the removed tumor NanoTherm ASI will be administered in a quantity of either 112 or 335 mgml of iron particles This is a sterile suspension of iron oxide nanoparticles in sterile water characterized by a high specific ability to absorb heat associated with its superparamagnetic properties At the site where the thickest layer of nanoparticles NanoTherm ASI is applied a catheter will be implanted allowing for measurement and control of temperature during the first activation in the magnetic field of the NanoActivator
Between the 6th and 10th day after the neurosurgical procedure a standard computerized tomography CT scan of the head will be performed for routine postoperative evaluation
After the first activation 10th day post-implantation of NanoTherm ASI the catheter will be removed Subsequently cyclically for 6 times the patient will be subjected to the variable magnetic field of the NanoActivator to induce hyperthermia ie increase the temperature of the site after the removed tumor and the surrounding tissues Activations will be conducted on the 10th 14th 17th 21st 24th and 28th day The heat released by the nanoparticles NanoTherm ASI into the surrounding tissue causes destruction or damage to the cells of the glioblastoma multiforme hyperthermia effect increasing their susceptibility to radiotherapy and chemotherapy
The patient will then be subjected to detailed observation for 2 years Observation will include visits conducted on the 60th 90th 150th 210th 270th and 360th day after surgery and then every 3 months up to 2 years post-procedure
On the 6th - 10th 90th 150th 210th 270th and 360th day after surgery and then every 3 months up to 2 years post-procedure a CT scan with an evaluation of treatment efficacy will be performed The treatment effects on CT will be analyzed using RANO Response Assessment in Neuro-oncology scale
During follow-up visits on the 60th 90th 150th 210th 270th and 360th day and then every 3 months up to 2 years after the surgical procedure a neurological examination assessment of adverse symptoms number of potential hospitalizations number of medical visits clinimetric assessment regarding quality of life EuroQuality of Life-5 dimensions 5- levels EQ-5D-5L Neurologic Assessment in Neuro-Oncology NanoScale 2 and clinimetric assessment regarding neurological deficit and degree of disability will be conducted modified Rankin scale Barthel index
The results from NanoTherm group will be compared to patients undergoing standard neurosurgical treatment for the abovementioned effects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None