EUCTR2021-003774-32-IT进行中（未招募）1 期
Enhancing Treatment in Persistent Glioblastoma through AGuIX Nanoparticles for Precision Radiotherapy (NanoGBM-Precision): A Phase II, monocenter, open-label, single-arm, no-profit clinical trial. - NanoGBM-Precision
DIPARTIMENTO BIOMEDICINA E PREVENZIONE UNIVERSITà DEGLI STUDI DI ROMA TOR VERGATA0 个研究点目标入组 30 人开始时间: 2021年9月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Patients who have previously a partial resection, biopsy or radiological diagnosis of Glioblastoma multiforme (GBM, WHO grade IV).
- •2.Not fit for Standard RT (60Gy/30 fractions over 6 weeks) in combination with Temozolomide
- •3.Patient’s age > 18 yo
- •4.Life expectancy = 3 months
- •5.Liver function (GGT, PAL, ASAT, ALAT, bilirubin) <1.5 times the upper normal limit
- •6.For patients receiving treatment with corticosteroids, treatment with corticosteroids must be at a stable or decreasing dose for at least 14 days before inclusion
- •7.Patient able to swallow and retain oral medication
- •8.Patients who have not received prior CHT or RT
- •9.Adequate renal function with standardized creatinine clearance = 50ml/min/1.73m²
- •10.Adequate hematological and hepatic functions: Platelet count > 100x10(9)/L (100,000 cells/mm3), Absolute granulocyte count (AGC) > 1.5 x 10(9)/L (1.500 cells/mm3), total serum bilirubin < 1.5 times the upper limit of normal, ALT (GPT) < 2.5 times the upper limit of normal and/or AST <2.5 times upper limit of normal.
- •11.Patient is able and willing to complete the quality-of-life questionnaires in Italian or any other official language into which the questionnaire is required to be translated. The baseline assessment must have already been completed.
- •12.Negative serum pregnancy test within 7 days before the first administration of treatment for women.
- •13.Women of childbearing potential and men whose partners are of childbearing potential must agree to use, themselves or their partners, an approved method of contraception throughout the treatment and at least 6 months after the last administration of study treatment.
- •14.Patient consent must be obtained according to local Institutional and/or University Human Experimentation Committee requirements.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1.Patients unable to undergo or tolerate MRI
- •2.Patients with contra-indication, sensitivity, or allergy to gadolinium or gadolinium-based contrast agents
- •3.Patients who have previously received brain irradiation
- •4.Patients with negative MRI within 72 hours after surgery
- •5.Age <18 yo
- •6.Standardized creatinine clearance < 50ml/min/1.73m²
- •7.History of nephropathy
- •8.Patients with, serious underlying medical conditions that would impair the ability of the patient to receive protocol treatment or with any condition that does not permit compliance with the protocol
- •9.Patients with known hypersensitivity to temozolomide or compounds with similar chemical composition to temozolomide.
- •10.Patients with known contra-indication, sensitivity or allergy to gadolinium
- •11.Patients unable to undergo or tolerate Magnetic Resonance Imaging or with known contra-indication (e.g. cardiac pacemaker, implanted defibrillator, certain cardiac valve replacements or certain metal implants).
- •12.Pregnancy or breastfeeding
- •13.Subject under administrative or judicial control
- •14.Psychological disorder or social or geographic reasons that may compromise medical monitoring of the trial or compliance with treatment
研究者
相似试验
进行中（未招募）
不适用
First Line Therapy of Glioblastoma Multiforme with Surgical Resection, Irradiation Therapy, Temozolomide and Additional Tumour-Lysate Pulsed Dendritic Cell Vaccination. A Feasibility Phase II Study. - NAGlioblastoma MultiformeEUCTR2009-013406-13-CZMasaryk University
招募中
不适用
Glioblastoma targeted treatment option maximization by WGS (GLOW);Maximizing treatment options for recurrent glioblastoma patients by whole genome sequencing-based diagnosticsGlioblstomamalignant brain tumor grade IV1002921110009720NL-OMON54315Haaglanden Medisch Centrum235
进行中（未招募）
不适用
First line standard therapy of glioblastoma multiforme with or without add-on treatment with Trivax, an anti-tumour immune therapy based on tumour-lysate charged dendritic cells - GBM-VaxPatients older than 3 years of age with newly diagnosed Glioblastoma Multiforme (GBM) undergoing brain surgery for removal of at least 70% of tumour mass and receiving subsequently standard radiation therapy and standard chemotherapy with temozolomide.MedDRA version: 14.1Level: PTClassification code 10018337Term: Glioblastoma multiformeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2009-015979-27-ATActivartis Biotech GmbH76
已完成
1 期
Enhancing Optune Therapy With Targeted CraniectomyGlioblastomaNCT02893137Aarhus University Hospital15
已完成
不适用
Survival of patients with recurrent malignant brain tumor (glioblastoma multiforme) treated with surgical resection and local chemotherapy using impregnated wafer (Gliadel® ) in relation to a clinical predictor; the methylation of methylguanin-DNA-methyltransferase (MGMT) promotorRecurrent glioblastoma multiforme WHO IV, primary treated by surgical resection and radiochemotherapy.CancerGlioblastoma MultiformeISRCTN15192099nfallkrankenhaus Berlin60