NOTICE OF LIMITED COMPETITION - REQUEST FOR COMPETITIVE RENEWAL APPLICATION: PEDIATRIC PHASE 1/PILOT CONSORTIUM Release Date: June 7, 2001 NOTICE: NOT-CA-01-015 National Cancer Institute The NCI is requesting a competitive renewal application from the Children’s Oncology Group (COG) to continue the clinical research activities of the Children’s Cancer Group (CCG) and the Pediatric Oncology Group (POG) Phase 1 Consortia that the NCI has supported since 1992. The COG Phase 1/Pilot consortium represents a merging of the previous activities that occurred when the pediatric Cooperative Groups joined into a single Cooperative Group in 2000. The COG Phase 1/Pilot consortium includes the major pediatric oncology centers in the United States, and its investigators have extensive expertise in the conduct of early phase clinical trials for children with cancer. The COG Phase 1/Pilot Consortium, through its ability to interact closely with COG Disease Committees, is uniquely positioned to prioritize agents for disease- specific pilot studies and then rapidly implement studies based on these decisions. The COG infrastructure for the conduct of clinical trials is state- of-the-art and takes advantage of new electronic communication technologies to allow rapid development of clinical trials and expedited reporting of clinical data from institutions to the COG Data/Statistical Center. By building on the data reporting mechanisms developed and used by COG, the COG Phase 1/Pilot Consortium will be able to reduce development and training costs for data collection, both centrally at the Data/Statistical Center and at local institutions. The NCI wants to continue the important activities of the COG Phase 1/Pilot Consortium and is seeking a single application from COG to accomplish this. The single application will include support for the necessary components of the Consortium, including its Operations Center, its Statistics/Data Center, its member institutions, and support for pharmacokinetic and correlative studies. Clinical trials conducted by the Consortium will include phase 1 trials, with a special emphasis on evaluations of agents with novel mechanisms of action and agents with distinctive molecular targets. The Consortium will also conduct pilot studies that require careful monitoring for toxicity and that may require pharmacokinetic or biologic sampling, with the objective of expeditiously establishing the safety and tolerability of these regimens so that they may then be evaluated in phase 3 trials.. NCI staff will contact the current awardee directly regarding application procedures and format. Written and telephone inquiries concerning this may be directed to: Dr. Malcolm Smith Cancer Therapy Evaluation Program Division of Cancer Treatment and Diagnosis National Cancer Institute 6130 Executive Boulevard, Room 7038, MSC 7436 Bethesda, MD 20892-7436 Telephone: (301) 496-2522 FAX: (301) 402-0557 Email: smithm@ctep.nci.nih.gov


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