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Childhood Cancer Survival Trends

Wilms. ALL. NB. AML. Childhood Cancer Survival Trends. 5 Yr Survival [%]. 1980-82. 1974-76. 1977-79. 1960-63. 1970-73. 1983-85. 1986-88. 1989-91. 1991-97. 1986-1995 N=675 . High-Risk Neuroblastoma 1978 - 1995. 1. 0.8. 0.6.

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Childhood Cancer Survival Trends

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  1. Wilms ALL NB AML Childhood Cancer Survival Trends 5 Yr Survival [%] 1980-82 1974-76 1977-79 1960-63 1970-73 1983-85 1986-88 1989-91 1991-97

  2. 1986-1995 N=675 High-Risk Neuroblastoma 1978 - 1995 1 0.8 0.6 Probability of Overall Survival 0.4 0.2 1978-1985 N=507 1 2 3 4 5 6 7 8 9 10 Years from Diagnosis

  3. Worst Degree of Any Toxicity (n=1062) No. of Patients Adapted from Crist et al, J Clin Oncol June 2001 Rhabdomyosarcoma Treatment

  4. Doxorubicin Cardiotoxicity Risk of CHF [%] Risk of CHF [%] Cumulative anthracycline dose [mg/m2] Time from start of anthracyline therapy [yr] Kremer et al JCO 2001

  5. Pediatric Phase 1 Trial of Gleevec • Phase 1 trial • Recommended dose • PK • Response • Potential targets • bcr-abl • PDGF-R • c-kit • Ph+ Leukemias • Osteosarcoma • Synovial sarcoma • Ewing’s sarcoma • Desmoplastic sarcoma • AML • GIST

  6. “Criteria” for Pediatric Phase 1 Study • Availability of new agent for pediatric studies • Relevance of drug target in pediatric malignancies • Activity in pre-clinical model systems • Experience in adult clinical trials

  7. PK, PD, PG Phase 1 Phase 1 Initiating Pediatric Phase 1 Trials Time Adult Trials: Phase 1 Phase 2 Phase 3 Phase 4 Phase 1 Pediatric Trials: Phase 1 Phase 1 Phase 1

  8. Limitations of Current Approach • Historically, patient numbers were rate limiting step for phase 1 trials. • Currently, insufficient number of new agents are in pediatric phase 1trials • Phase 1 trials initiated following drug approval for adults results in use in children without any pharmacologic, safety or efficacy data

  9. COG Phase 1 Consortium

  10. Solid Tumors PS-341 ZD1839 Flavopiridol Neuroblastoma Hu14.18-IL2 Select CNS Tumors Gadolinium-Texaphyrin Temozolomide/CCNU Cereport/Carboplatin Hematologic Arsenic Trioxide R115777 IDEC-Y2B8 Current COG Phase 1 Trials Dose levels fill in < 15 minutes Necessitated development of waiting lists

  11. Recommendations • Improve early access to new agents for pre-clinical studies • Initiate phase 1 trials of select agents when • Initial cohort(s) of adult patients in phase 1 are evaluable • Evidence of biologic activity observed

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