OF WILMS TUMOR XENOGRAFTS U S Food 肾母细胞瘤裸鼠移植瘤的灵敏度的美国食品课件.pptVIP

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OF WILMS TUMOR XENOGRAFTS U S Food 肾母细胞瘤裸鼠移植瘤的灵敏度的美国食品课件.ppt

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Predictive Models of CancerXenograft Models Of Childhood Solid Tumors Solid Malignancies Group St. Jude Children’s Research Hospital Human Tumor Xenografts Human cancers grown in immune-incompetent mice/rats. Models of most childhood solid tumors. Models of childhood ALL established. Xenograft Model Validation(Rhabdomyosarcoma) Model tumors respond qualitatively and quantitatively to drugs known to be active in the respective clinical disease: Diagnosis models: highly sensitive. Relapse models: significantly less responsive Models prospectively identify effective agents. Retrospective and Prospective Use of Rhabdomyosarcoma Xenografts SENSITIVITY OF WILMS TUMOR XENOGRAFTS Where do Xenograft Models Fit? Developing Relationships BetweenResponse and Drug Systemic Exposures Evaluation of MGI-114(Phase II in COG?) Neuroblastoma: Preclinical Prediction Topotecan: daily x 5 x 2 Preclinical: 4 of 6 objective responses @ 100 ng.hr/ml. Phase II targeted systemic exposure (AUC) 100 ng.hr/ml: Clinical: Stage IV Neuroblastoma 16/28 responses (57%) Where Do Xenograft Models Fit in Drug Development for Childhood Cancer? Conclusions Valid models of childhood cancers exist. Models reflect clinical drug sensitivity. Species differences in drug disposition, metabolism and tolerance are the major problems in accurately translating results. Models accurately identify clinically active agents when systemic exposure is normalized. Practical Considerations Access to drugs at an early stage Establishment of national consortium to encompass most childhood tumors Develop predictive pharmacokinetic models Characterize available models (genomic/proteomic screens) Develop a funding mechanism to support experimentalists involved in preclinical to clinical transitional science. * Drug Development For Children Has To Be Different Drug acquired NCI/Industry/Academia Phase I Unacceptable Toxicity Active Inactive Phase III Virtually no drugs are developed specifically to treat child