PHASE II STUDY OF BEVACIZUMAB PLUS IRINOTECAN (CAMPTORSAR) IN CHILDREN WITH RECR

贝伐珠单抗加伊立替康 (CAMPTORSAR) 在 RECR 儿童中的 II 期研究

• 批准号: 7717197
• 负责人: TOBEY J. MACDONALD
• 金额: $ 0.48万
• 依托单位: CHILDREN'S RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-12-01 至 2008-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7717197
• 关键词: Adult; Anticonvulsants; Bevacizumab/Irinotecan; Biology; Brain Stem Glioma; Brain scan; Child; Computer Retrieval of Information on Scientific Projects Database; Diffuse; Diffusion; Diffusion Magnetic Resonance Imaging; Dose; Drug Kinetics; Endothelial Growth Factors Receptor; Enzymes; Funding; Grant; Hour; Image; Institution; MRI Scans; Malignant Glioma; Mediating; Patients; Perfusion; Peripheral Blood Mononuclear Cell; Permeability; Phase; Phase II Clinical Trials; Phosphorylation; Positron-Emission Tomography; Recurrence; Research; Research Personnel; Resources; Scanning; Serum; Source; Standards of Weights and Measures; Toxic effect; Tumor Angiogenesis; United States National Institutes of Health; Vascular Endothelial Growth Factors; Vascular Permeabilities; Vertebral column; Week; bevacizumab; day; irinotecan; response; tumor; tumor progression

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. A phase II study of bevacizumab in combination with irinotecan will be performed in children with recurrent malignant glioma and diffuse brain stem gliomas. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously on day 1 and day 15 followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of begacizumab to assess whether there is reduction in permeability since VEGF mediates tumor angiogenesis and vascular permeability and bevacizumab directly inhibits VEGF. The first dose of irinotecan will be given intravenously following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m^2 every two weeks for those on EIACDS. If the patient is not on an EIACD, the starting dose will be 125 mg/m^2. These doses are routinely used with irinotecan is administered as a single-agent for malignant glioma in adults and children. Treatment will continue on study until tumor progression, unacceptable toxicity, or for a maximum if two years. Standard MRI scan of brain +/- spine, rapid perfusion and diffusion MRI, and FDG-PET scans prior to treatment and at periodic intervals will be obtained to study the effects of bevacizumab + irinotecan in these tumors. In addition, biology correlates will be studied including serum pharmacokinetics of bevacizumab and the expression of vacular endothelial growth factor receptor-2 on peripheral blood mononuclear cells and the effect of bevacizumab on VEGF-R2 phosphorylation. The latter would be correlated with tumor responses and MR perfusion changes in tumor following bevacizumab therapy.

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