MODIFICATION
A -- PEDIATRIC PRECLINICAL TESTING PROGRAM
- Notice Date
- 9/29/2003
- Notice Type
- Modification
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Research Contracts Br., 6120 Executive Blvd. EPS Suite 600, Rockville, MD, 20852
- ZIP Code
- 20852
- Solicitation Number
- N01-CM-37027-23
- Response Due
- 10/21/2003
- Archive Date
- 11/4/2003
- Point of Contact
- Doris Rosenblatt, Contracting Officer, Phone (301) 435-3824, Fax (301) 402-6699,
- E-Mail Address
-
dr220a@nih.gov
- Description
- The National Cancer Institute is seeking to establish a Pediatric Preclinical Testing Program to assist the Cancer Therapy Evaluation Program, NCI in fulfilling its mission to identify more effective treatments for children with cancer. The Contractor shall be responsible for the following tasks: A. TASK AREA 1 - IN VIVO TESTING In vivo testing panel: The Offeror shall establish and maintain a panel of pre-clinical models for 6 to 8 childhood cancers, with each cancer type represented by 6-10 different xenograft lines deemed suitable for in vivo drug testing (henceforth termed the pediatric pre-clinical panel). Stage 1 testing: The Offeror shall conduct experiments to evaluate the therapeutic potential of ten to fifteen agents (or combinations of agents) annually in the first stage of testing. Stage 1 testing of an agent shall involve evaluating the test agent's activity at its MTD against the entire pediatric pre-clinical panel. Stage 2 testing: For agents for which anti-tumor activity is observed in Stage 1 testing, Stage 2 testing shall include a further evaluation of the anti-tumor activity of the agent against the selected tumor types for which activity was observed in Stage 1. The testing to be performed in Stage 2 will vary depending upon the agent and the responsive tumor types, but may include developing a full dose response curve for the agent against the tumor types for which activity was identified in Stage 1 testing; studying the pharmacokinetics of the agent to correlate anti-tumor activity with the agent's blood levels; studying the agent in orthotopic mouse models and in models of metastatic disease; and studying the agent in relevant genetically engineered mouse models. B. TASK AREA 2 - IN VITRO TESTING In vitro testing: The Offeror shall establish and maintain a panel of in vitro models for selected childhood cancers to be used for in vitro testing of agents supplied to the Contractor. Ten to 15 agents entering Stage 1 testing will likely undergo in vitro testing each year against the in vitro panel, and an additional 4 to 8 other agents (or combinations of agents) will likely require testing each year. C. TASK AREA 3 - SPECIALIZED STUDIES Pharmacokinetic evaluations: The Offeror shall perform studies to determine systemic exposure and plasma elimination kinetics in appropriate animals using the routes of administration used for drug testing for agents progressing to Stage 2 testing for which there are not sufficient extant data describing the pharmacology of the agent in murine models. Molecular target assessment: The Offeror shall perform studies to determine to establish whether molecularly targeted agents have achieved target inhibition/modulation under test conditions for selected tested agents. The Government anticipates that one (1) cost reimbursement completion type contract will be awarded on an incrementally funded basis for a period of five (5) years. No collect calls will be accepted. The RFP will be available on or about August 20, 2003 with a due date for receipt of proposals of October 6, 2003. The RFP may be accessed through internet address: http://rcb.cancer.gov/rcb-internet/. It is the offeror's responsibility to monitor the above Internet site for the release of this Solicitation and Amendments, if any. POTENTIAL OFFER'S WILL BE RESPONSIBLE FOR DOWLOADING THEIR OWN COPY OF THE SOLICITATION AND AMENDMENTS. Point of contact: Doris Rosenblatt, Contracting Officer at e-mail: dr220a@nih.gov/ FAX: 301-402-6699; Telephone 301-435-3824. No collect calls will be accepted.
- Record
- SN00443847-W 20031001/030929213049 (fbodaily.com)
- Source
-
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