Application of Nanoparticles for Cyclic Hyperthermia In Adjuvant Therapy of gLioblastoma Multiforme (ANCHIALE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Progression free survival [units months 1-24]
研究概览
简要总结
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:
- how NanoTherm therapy influences overall survival, and progression free survival;
- 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.
详细描述
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 12,000 new cases of brain gliomas annually, and in Europe, there are about 25,000. 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 3.7/100,000 for men and 2.6/100,000 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 and/or chemotherapy is considered. This treatment is used according to the protocol published by Stupp in 2005.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
ANCHIALE is open-label study
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recurrence of glioblastoma multiforme.
- •Age > 18 years.
- •Informed written consent to participate in the study.
- •Karnofsky performance score ≥
- •Expected survival time > 6 months.
- •Failure of standard treatment according to the Stupp protocol.
- •Cardio-respiratory fitness - allowing to stay for 60 minutes in a lying position in the field activator.
排除标准
- •Pregnant or breastfeeding women.
- •More than 3 foci of glioblastoma multiforme.
- •Tumor invasion of eloquent or motor areas.
- •Subependymal contrast enhancement in the adjacent brain ventricles.
- •Concurrent immunotherapy for glioblastoma.
- •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.
- •Electronic implants: pacemakers, cardioverter defibrillators, cochlear implants, deep brain stimulation (DBS) electrodes.
- •Allergy/hypersensitivity to aminosilanes, iron oxide, acetic acid.
- •Planned or current treatment with electromagnetic field in the Optune®TTF system.
- •Claustrophobia not amenable to control.
- •Painful conditions, musculoskeletal system diseases that prevent staying in a lying position.
研究组 & 干预措施
NanoTherm arm (group A)
Recurrent glioblastoma multiforme patients treated with NanoTherm therapy.
干预措施: NanoTherm therapy (Device)
NanoTherm arm (group A)
Recurrent glioblastoma multiforme patients treated with NanoTherm therapy.
干预措施: Glioma Resection (Procedure)
Stupp protocol (group B)
Glioblastoma multiforme patients treated according to Stupp protocol including surgery, chemotherapy and radiotherapy.
干预措施: Glioma Resection (Procedure)
Stupp protocol (group B)
Glioblastoma multiforme patients treated according to Stupp protocol including surgery, chemotherapy and radiotherapy.
干预措施: radiotherapy according to Stupp protocol (Radiation)
Stupp protocol (group B)
Glioblastoma multiforme patients treated according to Stupp protocol including surgery, chemotherapy and radiotherapy.
干预措施: chemotherapy according to Stupp protocol (Drug)
结局指标
主要结局
Progression free survival [units months 1-24]
时间窗: 2 years after surgery
Progression Free Survival
Survival following the surgery [units months 1-24]
时间窗: 2 years following surgery
overall survival
次要结局
- modified Rankin scale [0-best; 6-worst](2 years after surgery)
- EuroQuality of Life 5-dimensions-5 levels scale (EQ-5D-5L) [arbitraty units 0- worst ; 100 - best](2 years after surgery)
- Neurologic Assessment in Neuro-Oncology (NanoScale 2) [0-best; 23-worst](2 years after surgery)
- Response Assessment in Neuro-oncology [1 - complete response; 4 -progressive disease](2 years after surgery)
- Barthel index [range 0-100; 0-best, 100-worst](2 years after surgery)
研究者
Slawomir Michalak
MD, PhD, Prof., head of department
Poznan University of Medical Sciences