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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