Contact:
Malcolm Smith, MD, PhD
Assoc Branch Chief, Pediatrics
Cancer Therapy Evaluation Program, NCI
6130 Executive Boulevard
Room 7025
Bethesda, MD 20892
Rockville, MD 20852 (Overnight)
Bus: 301-496-2522
Bus Fax: 301-402-0557
E-mail: smithm@ctep.nci.nih.gov

Objective of Project:

The purpose of the RFA reissuance is to continue NCI’s program for the development of new agents for children with cancer through the Children’s Oncology Group (COG) Phase 1/Pilot Consortium. The Consortium will be responsible for timely conduct of the “first in children” phase 1 and pilot studies that are essential to NCI’s overall clinical research program for children with cancer.

Description of Project:

The Phase 1/Pilot Consortium will continue to be supported through a U01 Cooperative Agreement funding mechanism. The total amount of funding that NCI expects to award through this reissuance in FY 2007 is approximately $3.305M. The total commitment for five years of funding is $16.527M. The applicant may request a project period of up to five years, with the award period being from 8/01/07 to 7/31/12. Support through the award will be provided for scientific leadership, for regulatory and administrative support (including protocol development), for data management and analysis, for support of approximately 20 member institutions, and for support of pharmacokinetic and pharmacodynamic studies (including imaging studies). The Consortium will be expected to introduce 6-7 new agents or combinations of agents into the childhood cancer setting per year and to pilot 2-3 new regimens for specific childhood cancers each year. Pharmacokinetic and pharmacodynamic endpoints will be included in Consortium studies as appropriate, and imaging endpoints will be utilized when available and relevant to meeting study objectives.