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Program) Rate 1 in 7,000 in children 0-15 yearsB[1   &  < 9,000 cases/yr 3,700 cases/yr. 1,500 cases/yr. 14,200&=$ %Ages 0-15 y Ages 15-19 y Ages 19-21 y&&=47Distribution of Pediatric Cancer Diagnoses by Age Group88 |jChildhood Cancer Survival Data(>5`Clinical Research Focus  Need For New Therapies11(Current 5yr. EFS rate  77% Mortality from childhood cancer: >50% decrease (1975-1995) Annual decrease in mortality rate (1990-2000) <2% Acute and long-term toxicities preclude therapy intensification 2 leukemias/SMN preclude extension of cumulative dosesZ?6`Clinical Research Focus  Need For New Therapies11(Despite dramatic improvements in cure rates, certain cancers remain a challenge High risk ALL MYCN amplified NBL Metastatic Sarcomas Gliomas  Brain stem and High Grade Long-term sequelae of current treatments8PY)PY )@7ICritical Role of Laboratory and Translational Research in Future ProgressJJ dMaximized gain from historical approaches Exploiting basic biology: the immune system, the human genome, and genetic perturbations of the cancer cell in developing new therapeutic approaches Correlative laboratory research in clinical trials: prognostic factors and refinements of risk  adjusted therapy B2E{4=C9F;  G<)Key Components of Successful ALL Therapy**(Empiric multi-agent chemotherapy Pre-symptomatic CNS therapy Post-induction intensification Anti-metabolite based therapy Re-induction/re-consolidation Risk adapted therapyJ\ < "  \<H=ALL: The Challenge( Despite the success, nearly 25% of children/youth with ALL relapse Curative, salvage therapy: intensive, stem cell transplant regimens 2nd leading cause of cancer-related mortality Many cured patients are over-treated and risk unnecessary morbidity4ZZoyGenetic Heterogeneity in Childhood ALL Children s Oncology GroupAA z{|I>"Leukemia Research: The Next Level  #!$$ Investigation of the Biology of the Host and the Leukemia Cell and Environmental Interactions Pharmacogenetics: Gene polymorphisms Etiology: Exposure detoxification Drug resistance: Treatment failure Drug metabolism: Toxicity/morbidity DiibQ'Challenges in Pediatric Cancer Research(((eU2Clinical Challenges in New Cancer Drug Development33(Relatively low cancer incidence  unfavorable market forces Unique pediatric cancers Development (age  related) Changes in organ function: absorption, distribution and clearance Other pK and pD differences Optimism  Pediatric exclusivity  PREA - BPCA<qZBZKZqBKfV*Critical Criteria for Selecting New Agents++$Novel mechanism of action Favorable toxicity profile pK considerations (e.g. pharmacologic sanctuary sites) Measurable endpoints: correlation of pK and outcome$gW2Prioritization of Agents for Pediatric Development33 Sound rationale Compelling pre-clinical data (in vivo, in vitro pediatric models) Preliminary adult experience Drug availability and long term development plan Disease-specific scientific agenda0Z. z}HThe Adolescent and Young Adult  Gap %%(64% of  pediatric cancer patients between 15-21 not seen at a pediatric center 60% of eligible patients age 15-21 are not entered on open clinical trials Age related survival differences (15-19, 19-21, 21-25, 25-30) exist for nearly every cancer type most commonly seen in children and adolescents  ALL, Ewing, Rhabdomyosarcoma, OsteosarcomaXZX~Epidemiology of AYA OncologyAge-specific PrognosisAll Malignancies,:Hematologic Malignancies in Adolescents/Young Adults (AYA);;(Comprise 35% of cancers in patients age 15-19; 23% of all cancers in 20-29 year olds Survival rates correlate with level of participation in clinical trials AYAs are least likely population to participate in clinical trials (CTEP data) Problem compounded by lack of consistency in approach to treatment: Adult vs. pediatric hematologist/oncologist Paucity of specific outcome data on AYAsD0ZUZ ~UD Prognosis in ALL worsens with age: SEER registry data (1986-1995) &E$B +NCI Goals and Objectives: The COG Position,,, oZPediatric Cancer Research: Special Considerations for Discovery, Development, and Delivery[[Incidence rates result in relatively small patient (study) population Mandates multi-center (national/international) clinical trials and translational research network Improved outcome results in childhood cancer and integration of biology in pediatric clinical trials is perhaps the most tangible evidence of success of the NCI Cooperative Group Program Despite dramatic improvements in outcome  cancer is the leading cause of death from disease in children and adolescents,P rIntegrative Cancer Biology(.Enhanced investigations of genomic/proteomic  signature of cancer cells in large populations of similarly treated children required to assess prognostic/predictive value Existing extensive, well catalogued and classified tumor and cell banks linked to robust annotated clinical databases Linkage of demographic and outcome data with molecular genetic classification key to understanding causation and explanations for treatment failure as well as potential therapeutic target identification Special emphasis on Pediatric Cancer (solid tumors and leukemias) through P-30/P-50 programs and SPECS to drive investigations for target discovery and validation as well as therapy development and delivery within the context of a National Children s Cancer Center, a cancer center without wallsPPvPPPP)P!!q-Strategic Development of Cancer Interventions..(*Seamless continuum of discovery to development to delivery currently exists within the existing NCI-supported pediatric clinical trials infrastructure Implementation of screening initiatives and prevention strategies can best be accomplished through same existing NCI-supported clinical trials network Existing and expanded network facilitation of public-private partnerships for cancer drug development in relatively orphan diseases with appropriate, federally-approved incentivization strategies to address therapy development expense and market forces,+Zn iYMolecular Epidemiology$Near population-based trials and non-therapeutic studies (every North American pediatric cancer program) Need for national childhood cancer registry (Children s Cancer Research Network) Links to annotated databases (clinical, demographic and outcome) and specimen banks Genetic linkage to exposure assessment Evaluation of polymorphisms and relationship to risk, therapy response, risk of SMNPk]Overcoming Health Disparities(Near population based (entire U.S.) study opportunities for evaluation of racial, ethnic, socio-economic factors on incidence, access to trials (care), and outcome Unique opportunity to link such trials with molecular epidemiology investigations to evaluate potential gene effect(s) in incidence/outcome Unique nationwide opportunity to design and conduct intervention studies to abrogate any identified disparities and advocate for policy change@lZ*Early Detection, Prevention and Prediction++ Expansion of focus of Long-Term Follow-up Guidelines: development of risk-based screening programs for SMN Development and implementation of strategies (behavioral, chemo-prevention) to reduce risk of cancer and SMN in childhood cancer survivors Coordinate and lead effort within general pediatric community to design and implement prevention strategies for adult cancers using medical, bio-behavioral and lifestyle change approaches in children,Z65SSummaryCollaborative, multi-center clinical research responsible for improved overall and disease-specific outcomes in pediatric cancer Specific disease groups (Dx, extent of disease, biology) remains a challenge Cancer remains the leading cause of death from disease Future programs requires increased investment in translational research linked to an effective national clinical trials infrastructureZ/A} !  0` 3` ff>>\fg` J*T333` QYmx~3ft` \ғhEy`` cb^DDf`Y˵W` sg7xGr` K%ޯd{mG/` 33f>?" dd@,?nFd@    @ `  n?" dd@   @@``PR    @ ` `<p>> ^V((  ( ( 6  #" `b `   X*  ( 6  #" `` `   Z* xT ~ ( "~\ { ( "{ ( c BB CDEFd @ bb   H   T W6Vw}\gFQ6<1++11 1L b6xQrq 6\}N   - c    0 A Q g     S    6N KawF bFy0 a*ly7lE;uz  B | a F 0 ! 1 < B < & l L 0  @`"T  ( c |BC+DEFyd @ ==gL6cI}\eA& w6m!W<! &<W!r6W}F6\}>68QNlX^XH8+Sgg|@`"Jo 5 J (  B! 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