NABTT 0306 EMD 121974 TRIAL
NABTT 0306 EMD 121974 试用版
基本信息
- 批准号:7603223
- 负责人:
- 金额:$ 5.04万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2007
- 资助国家:美国
- 起止时间:2007-03-01 至 2008-02-29
- 项目状态:已结题
- 来源:
- 关键词:AdjuvantAngiogenesis InhibitorsAntimitotic AgentsBlood VesselsBlood VolumeBlood flowCell-Matrix JunctionCellsChickensClinicalClinical TrialsComputer Retrieval of Information on Scientific Projects DatabaseDiagnosisDoseDose-LimitingEMD 121974 (Cilengitide)EnrollmentEventExhibitsFundingGlioblastomaGliomaGrantGrowthHourHumanIn VitroIndividualInfusion proceduresInstitutionIntegrin alphaVbeta3IntegrinsMalignant GliomaMalignant NeoplasmsMediatingMolecularMolecular ProfilingMorbidity - disease rateMusNew Approaches to Brain Tumor Therapy ConsortiumNewly DiagnosedNude MiceOutcomePatientsPerfusionPermeabilityPharmaceutical PreparationsPlayPropertyRadiation therapyResearchResearch PersonnelResourcesRoleSafetySevere Combined ImmunodeficiencySourceSystemToxic effectTumor VolumeUnited States National Institutes of HealthUpper armangiogenesischorioallantoic membraneexperiencein vivoinhibitor/antagonistintegrin beta5membrane modelmigrationmortalityneoplastic cellreceptortemozolomidetumortumor growth
项目摘要
This subproject is one of many research subprojects utilizing the
resources provided by a Center grant funded by NIH/NCRR. The subproject and
investigator (PI) may have received primary funding from another NIH source,
and thus could be represented in other CRISP entries. The institution listed is
for the Center, which is not necessarily the institution for the investigator.
The objectives of this clinical trial are to assess the safety profile of EMD 121974 (cilengitide) when administered as a one-hour infusion twice weekly concurrently with concomitant and adjuvant temozolomide with radiation therapy for newly diagnosed glioblastoma multiforme. The study also will help to estimate the overall survival in newly diagnosed patients with glioblastoma multiforme treated with EMD 121974 concurrently with concomitant and adjuvant temozolomide with radiation therapy. Secondary objectives include: estimating and comparing the overall survival between a low dose treatment group and a high dose treatment group in newly diagnosed patients treated with EMD 121974 concurrently with concomitant and adjuvant temozolomide with radiation therapy. Determining the toxicity of EMD 121974 when it is administered in
conjunction with concomitant and adjuvant temozolomide with radiation therapy. Evaluating the molecular profile of individual patients and correlate molecular expression profiles with clinical outcomes. And lastly to characterize tumor blood volume, tumor blood flow, and permeability ratios using perfusion MR in newly diagnosed glioblastoma multiforme and follow these parameters during treatment with EMD 121974. Malignant gliomas are among the deadliest form of cancer. The morbidity and mortality surrounding the diagnosis of glioblastoma multiforme can be attributed to the invasiveness of glioma cells and robust blood vessel growth associated with this tumor. EMD 121974 has an antiangiogenic property. It is a potent and selective alpha v, beta 3 and alpha v, beta 5 integrin receptor antagonist that blocks alpha v-integrin-mediated cell attachment and migration. It has been shown to inhibit tumor growth in various in vivo systems including chicken chorioallantoic membrane model, nude mice, and severe combined immunodeficiency mice inoculated with human tumor cells. In addition, alpha v, beta 3 integrins are expressed in GBM and play a role in tumor growth. It has been shown in in
vitro studies that inhibitors of these integrins not only inhibit angiogenesis, but also exhibit potent antimitotic effects. EMD 121974 has the potential to impact GBM tumor growth not only by its antiangiogenic effect, but also by direct inhibition of tumor growth. This clinical trial will enroll a maximum of 94 patients, approximately 47 patients in each arm. The patients will receive a twice weekly, one hour infusion of the study drug until they experience a dose-limiting toxicity or major event or meet other criteria for going off treatment.
这个子项目是许多研究子项目中利用
资源由NIH/NCRR资助的中心拨款提供。子项目和
调查员(PI)可能从NIH的另一个来源获得了主要资金,
并因此可以在其他清晰的条目中表示。列出的机构是
该中心不一定是调查人员的机构。
这项临床试验的目的是评估EMD 121974(西仑肽)在新诊断的多形性胶质母细胞瘤放射治疗的同时,每周两次,同时给予替莫唑胺1小时输注的安全性。这项研究还将有助于估计新诊断的多形性胶质母细胞瘤患者的总体存活率,这些患者在接受EMD 121974治疗的同时,同时辅以替莫唑胺和放射治疗。次要目标包括:估计和比较在放射治疗的同时使用EMD 121974同时使用替莫唑胺和辅助剂替莫唑胺治疗的新诊断患者的低剂量治疗组和高剂量治疗组之间的总存活率。EMD 121974在人体内应用的毒性测定
配合替莫唑胺辅助放射治疗。评估单个患者的分子图谱,并将分子表达图谱与临床结果相关联。最后利用MR灌注成像技术对新诊断的多形性胶质母细胞瘤的肿瘤血流量、肿瘤血流量和通透性比率进行表征,并在使用EMD 121974治疗期间遵循这些参数。恶性胶质瘤是最致命的癌症之一。多形性胶质母细胞瘤的发病率和死亡率可归因于胶质瘤细胞的侵袭性和与该肿瘤相关的强劲的血管生长。EMD 121974具有抗血管生成的特性。它是一种有效和选择性的αv,β3和αv,β5整合素受体拮抗剂,可以阻断αv整合素介导的细胞附着和迁移。在多种体内系统中,包括鸡绒毛膜模型、裸鼠和接种人肿瘤细胞的严重联合免疫缺陷小鼠,它都显示出抑制肿瘤生长的作用。此外,整合素αv、β3在基底膜中表达,并在肿瘤生长中发挥作用。它已显示在
体外研究表明,这些整合素的抑制剂不仅抑制血管生成,而且显示出强大的抗有丝分裂作用。EMD 121974不仅通过其抗血管生成作用,而且通过直接抑制肿瘤生长,有可能影响基底膜肿瘤的生长。这项临床试验将最多招募94名患者,每支手臂大约有47名患者。患者将接受每周两次、一小时的研究药物输注,直到他们出现剂量限制的毒性或重大事件或满足停止治疗的其他标准。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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BURTON L NABORS其他文献
BURTON L NABORS的其他文献
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{{ truncateString('BURTON L NABORS', 18)}}的其他基金
PS 341 IN THE TREATMENT OF RECURRENT GLIOMAS
PS 341 治疗复发性神经胶质瘤
- 批准号:
7603179 - 财政年份:2007
- 资助金额:
$ 5.04万 - 项目类别:
NABTT 0401 - BAY 43-9006 FOR PATIENTS WITH GLIOMA
NABTT 0401 - BAY 43-9006 适用于神经胶质瘤患者
- 批准号:
7603219 - 财政年份:2007
- 资助金额:
$ 5.04万 - 项目类别:
PS 341 IN THE TREATMENT OF RECURRENT GLIOMAS
PS 341 治疗复发性神经胶质瘤
- 批准号:
7380416 - 财政年份:2006
- 资助金额:
$ 5.04万 - 项目类别:
NABTT 0401 - BAY 43-9006 FOR PATIENTS WITH GLIOMA
NABTT 0401 - BAY 43-9006 适用于神经胶质瘤患者
- 批准号:
7380475 - 财政年份:2006
- 资助金额:
$ 5.04万 - 项目类别:
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