ACTRN12623000096651招募中2 期
MOS2: Low & Anaplastic Grade Glioma Umbrella Study of Molecular Guided TherapieS
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 57
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Molecular profiling:
- •1. Adults, aged 18 years and older
- •2. Histologically confirmed glioma, IDH-mutant, histologically grade 2 or 3 at initial diagnosis (i.e., without necrosis or microvascular proliferation); including CDKN2A/B homozygous deleted IDH-mutant astrocytomas but not IDH-wildtype diffuse astrocytomas with any of TERT promoter mutation, EGFR amplification and/or +7/-10 copy number changes (i.e., molecular features of glioblastoma).
- •3. Has evidence of progressive disease (defined as new contrast-enhancing tumour and/or 25% increase in the size of the T2/FLAIR area compared to prior imaging after prior treatment with radiotherapy and chemotherapy; with a clinical indication for neurosurgery).
- •4. Prior treatment with radiotherapy and alkylating chemotherapy, defined as either sequential therapy with CNS radiotherapy then an akylating agent, or concurrent CNS radiotherapy with an alkylating agent.
- •5. ECOG performance status 0-2.
- •6. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments; It is the intention that molecular profiling is performed for patients who are in principle wishing to take part in a treatment arm if they are found to be eligible following molecular profiling.
- •7. Signed, written informed consent (LUMOS2 molecular profiling and linkage to Medicare records).
- •Additional inclusion criteria for:
- •Arm 1 - Paxalisib:
- •1. Histologically confirmed glioma, IDH-mutant, histologically grade 2 or 3 at initial diagnosis (i.e., without necrosis or microvascular proliferation); including CDKN2A/B homozygous deleted IDH-mutant astrocytomas but not IDH-wildtype diffuse astrocytomas with any of TERT promoter mutation, EGFR amplification and/or +7/-10 copy number changes (i.e., molecular features of glioblastoma).
- •2. Adequate recovery from surgery in the opinion of the treating physician (as evidenced by ECOG performance status 0-2).
- •3. Adequate organ system function post-surgery as assessed by the following minimal laboratory requirements.
- •a) Bone marrow function; platelets greater than or equal to 100 x 109/L, ANC greater than or equal to 1.5 x 109/L, and haemoglobin greater than or equal to 90g/L (5.6mmol/L)
- •b) Liver function; ALT/AST less than or equal to 3 x ULN and total bilirubin less than or equal to 1.5xULN
- •c) Renal function; serum creatinine less than or equal to 1.5xULN
- •4. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments.
- •5. LUMOS2 Molecular Tumour Advisory Panel (MTAP) report confirming eligibility to this treatment arm.
- •6. Signed, written informed consent
- •Arm 2 - AK104:
- •1. Histologically confirmed glioma, IDH-mutant, histologically grade 2 or 3 at initial diagnosis (i.e., without necrosis or microvascular proliferation); including CDKN2A/B homozygous deleted IDH-mutant astrocytomas but not IDH-wildtype diffuse astrocytomas with any of TERT promoter mutation, EGFR amplification and/or +7/-10 copy number changes (i.e., molecular features of glioblastoma).
- •2. Adequate recovery from surgery in the opinion of the treating physician (as evidenced by ECOG performance status 0-2).
- •3. Adequate organ system function post-surgery as assessed by the following minimal laboratory requirements
- •a. Bone marrow function; platelets greater than or equal to 100 x 109/L, ANC greater than or equal to 1.5 x 109/L, and haemoglobin greater than or equal to 90g/L (5.6mmol/L)
排除标准
- •Molecular profiling:
- •1. Prior treatment with bevacizumab
- •2. Intra-surgical treatments (e.g., oncolytic virus administration, Gliadel wafers) at their last craniotomy prior to study enrolment.
- •3. Comorbidities or conditions (e.g., psychiatric) that may compromise assessment of key outcomes or in the opinion of the physician limit the ability of the participant to comply with the protocol.
- •4. Unable (e.g., due to pacemaker or ICD device) or unwilling to have a contrast-enhanced MRI of the head
- •5. Any unresolved toxicity (>CTCAE grade 2) from previous anti-cancer therapy (Those with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripheral neuropathy))
- •6. Pregnancy, lactation, or inadequate contraception. Persons who are able to become pregnant, and having sexual relationships in which they may become pregnant, must use a reliable means of contraception and must have a negative pregnancy test done within 7 days prior to registration. Persons who are having sexual relationships in which their partner may become pregnant must have been surgically sterilised or use a (double if required) barrier method of contraception.
- •Additional exclusion criteria for:
- •Arm 1 - Paxalisib:
- •1. Intra-surgical treatments (e.g., oncolytic virus administration, Gliadel wafers) at their last craniotomy prior to study enrolment;
- •2. Presence of any metastatic tumours at the time of craniotomy that are not consistent with original glioma diagnosis.
- •3. Prior IDH inhibitor therapy within 4 weeks of first dose of LUMOS2 investigational treatment.
- •4. Prior investigational agents within 4 weeks of first dose of LUMOS2 investigational treatment.
- •5. Concomitant medications which may interact with the investigational product(s) in the opinion of the physician
- •6. Baseline QT interval >470msec or clinically significant cardiac history (myocardial infarction or symptomatic bradycardia, active congestive heart failure or angina pectoris).
- •Arm 2 - AK104:
- •1. Intra-surgical treatments (e.g., oncolytic virus administration, Gliadel wafers) at their last craniotomy prior to study enrolment
- •2. Presence of any metastatic tumours at the time of craniotomy that are not consistent with original glioma diagnosis.
- •3. Prior IDH inhibitor therapy within 4 weeks of first dose of LUMOS2 investigational treatment.
- •4. Prior investigational agents within 4 weeks of first dose of LUMOS2 investigational treatment.
- •5. Concomitant medications which may interact with the investigational product(s) in the opinion of the physician.
- •6. Clinically significant symptomatic auto-immune disease that may predispose patient to immune-related adverse events in the opinion of the treating physician.
- •Arm3 - Selinexor:
- •1. Intra-surgical treatments (e.g., oncolytic virus administration, Gliadel wafers) at their last craniotomy prior to study enrolment;
- •2. Presence of any metastatic tumours at the time of craniotomy that are not consistent with original glioma diagnosis.
- •3. Prior IDH inhibitor therapy within 4 weeks of first dose of LUMOS2 investigational treatment.
- •4. Prior investigational agents within 4 weeks of first dose of LUMOS2 investigational treatment.
- •5. Concomitant medications which may interact with the investigational product(s) in the opinion of the physician.
研究者
相似试验
已完成
不适用
OMICS analysis of gliomagliomaJPRN-UMIN000011955Kyoto University Graduate School of Medicine Center for Genomic Medicine40
招募中
不适用
2-HG spectroscopy in low grade glioma patients treated with vorasidenib - a pilot studylow grade brain tumorLow grade glioma10029211NL-OMON56925niversitair Medisch Centrum Groningen15
招募中
2 期
Feasibility of Individualized, Model-guided Optimization of Proton Beam Treatment Planning in Patients With Low Grade GliomaLow Grade GliomaNCT05964569University Hospital Heidelberg120
进行中（未招募）
1 期
International Consortium on Low Grade Glioma - ICLGG of the International Society of Pediatric Oncology - SIOPCooperative multicenter Study for Children and Adolescents with Low Grade Glioma SIOP - LGG 2003 - LGG2ow grade glioma.EUCTR2005-005377-29-IEOur Lady's Hospital for Sick Children
进行中（未招募）
不适用
Glioma Mesoscopic ImagingC71.9D43.2Brain, unspecifiedDRKS00005580niversitätsklinikum Freiburg37