The mission of the Children's Oncology Group (COG) Phase 1 and Pilot Consortium is to identify and develop effective new agents for children and adolescents with cancer, through rational and efficient clinical and laboratory research. This limited institution consortium, comprised of 21 premier pediatric oncology programs in the country that were selected through a peer review process, serves as a national and international model for new agent development in pediatric oncology. The Consortium successfully leverages the database infrastructure and resources of the parent Children's Oncology Group (COG) while maintaining its own administrative and operational infrastructure to ensure rapid development, implementation and reporting of specialized and complex early phase clinical trials. The Consortium has expert resources for the conduct of translational biology, pharmacokinetic, and pharmacogenetics studies, and has developed a state-of-the art infrastructure to facilitate image transfer of specialized correlative imaging studies for central review and analyses. The Consortium's primary specific aims are: 1) To perform phase 1 trials of agents that target specific tumor types based on available data from preclinical tumor model systems, known molecular targets, and/or adult clinical trial data;2) To collaborate with COG Disease Committees to develop and conduct pilot studies of promising new treatment approaches with specific types of cancer, based on available data from tumor model systems, the molecular profile of the tumor, and pediatric phase 1 or 2 trial data;and 3) To incorporate pharmacokinetic and pharmacodynamic endpoints, including imaging and/or translational laboratory studies, as appropriate into Phase 1 and pilot studies to facilitate future development of the new treatment approaches. The development of targeted therapy for childhood cancers is a high priority as such therapeutics offer the prospect of being more efficacious and less toxic.

Public Health Relevance

The Children's Oncology Group Phase 1 and Pilot Consortium comprises 21 premier pediatric oncology centers in North America. Our primary goal is to efficiently develop new anti-cancer agents and therapeutic strategies for children with recurrent or refractory cancer to increase the overall cure rate for childhood cancer. We also strive to develop targeted anti-cancer therapies that reduce long term side effects.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Research Project with Complex Structure Cooperative Agreement (UM1)
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Special Emphasis Panel (ZCA1-RPRB-J (O2))
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Smith, Malcolm M
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Children's Hospital of Philadelphia
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Leary, Sarah E S; Park, Julie R; Reid, Joel M et al. (2017) Pediatric Phase I Trial and Pharmacokinetic Study of Trebananib in Relapsed Solid Tumors, Including Primary Tumors of the Central Nervous System ADVL1115: A Children's Oncology Group Phase I Consortium Report. Clin Cancer Res 23:6062-6069
Geller, James I; Perentesis, John P; Liu, Xiaowei et al. (2017) A phase 1 study of the c-Met inhibitor, tivantinib (ARQ197) in children with relapsed or refractory solid tumors: A Children's Oncology Group study phase 1 and pilot consortium trial (ADVL1111). Pediatr Blood Cancer 64:
Rheingold, Susan R; Tasian, Sarah K; Whitlock, James A et al. (2017) A phase 1 trial of temsirolimus and intensive re-induction chemotherapy for 2nd or greater relapse of acute lymphoblastic leukaemia: a Children's Oncology Group study (ADVL1114). Br J Haematol 177:467-474
Mizuno, Tomoyuki; Fukuda, Tsuyoshi; Christians, Uwe et al. (2017) Population pharmacokinetics of temsirolimus and sirolimus in children with recurrent solid tumours: a report from the Children's Oncology Group. Br J Clin Pharmacol 83:1097-1107
Balis, Frank M; Thompson, Patrick A; Mosse, Yael P et al. (2017) First-dose and steady-state pharmacokinetics of orally administered crizotinib in children with solid tumors: a report on ADVL0912 from the Children's Oncology Group Phase 1/Pilot Consortium. Cancer Chemother Pharmacol 79:181-187
Mossé, Yael P; Voss, Stephan D; Lim, Megan S et al. (2017) Targeting ALK With Crizotinib in Pediatric Anaplastic Large Cell Lymphoma and Inflammatory Myofibroblastic Tumor: A Children's Oncology Group Study. J Clin Oncol 35:3215-3221
Burke, Michael J; Ahern, Charlotte; Weigel, Brenda J et al. (2015) Phase I trial of Seneca Valley Virus (NTX-010) in children with relapsed/refractory solid tumors: a report of the Children's Oncology Group. Pediatr Blood Cancer 62:743-50
Voss, Stephan D; Glade-Bender, Julia; Spunt, Sheri L et al. (2015) Growth plate abnormalities in pediatric cancer patients undergoing phase 1 anti-angiogenic therapy: a report from the Children's Oncology Group Phase I Consortium. Pediatr Blood Cancer 62:45-51
Loh, Mignon L; Tasian, Sarah K; Rabin, Karen R et al. (2015) A phase 1 dosing study of ruxolitinib in children with relapsed or refractory solid tumors, leukemias, or myeloproliferative neoplasms: A Children's Oncology Group phase 1 consortium study (ADVL1011). Pediatr Blood Cancer 62:1717-24
Fouladi, Maryam; Perentesis, John P; Wagner, Lars M et al. (2015) A Phase I Study of Cixutumumab (IMC-A12) in Combination with Temsirolimus (CCI-779) in Children with Recurrent Solid Tumors: A Children's Oncology Group Phase I Consortium Report. Clin Cancer Res 21:1558-65

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