Purpose: The purpose of this Request for Applications (RFA) is to provide funding to assess novel agents available through the NCI in early clinical, dose finding trials. This initiative's major objective is the timely completion of trials of promising anti-cancer agents and combinations of agents to establish safe and biologically active treatment schedules for patients with cancer and to establish proof of principle for new agents directed at novel molecular targets. Most of these trials will include pharmacokinetic assessment. Many of these trials will include assessment of drug exposure and effect. These assessments may provide an understanding of the relationship between the drug's doses and schedules and its effects. This RFA invites investigators to form teams of investigators and support staff to propose, develop, perform and analyze the results of early clinical trials. These teams should include clinical investigators with expertise in the performance of early clinical trials, collaborating with researchers with expertise in clinical pharmacology and translational correlative studies as well as support staff. Single Institution Phase I studies are preferred, although laboratory studies may be conducted with collaborators at other institutions. Strong justification, evidence of well-established collaborations and clearly described procedures must be supplied for multi- institutional applications.
Term/Amount: The NCI intends to commit in FY2003 approximately $7,200,000 including direct costs and costs for Facilities and Administration to fund 14-15 new and/or competing continuation cooperative agreements in response to this RFA. An applicant may request a project period of up to five years. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. The NCI policy that R01 and U01 applications cannot exceed an increase of 20% over the direct cost award level in the last non-competing (type 5) year does not apply to the applications received in response to this RFA. Although the financial plans of the NCI provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.
Contact: The Letter of Intent is to be sent to Dr. Louise B. Grochow Chief, Investigational Drug Branch Cancer Therapy Evaluation Program Division of Cancer Treatment and Diagnosis National Cancer Institute Executive Plaza North, Room 7131 6130 EXECUTIVE BLVD MSC 7426 BETHESDA, MD 20892-7432 Telephone: (301) 496-1196 FAX: (301) 402-0428 E-mail: grochowl{at}ctep.nci.nih.gov The PHS 398 research grant application instructions and forms (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html must be used in applying for these cooperative agreements. This version of the PHS 398 is available in an interactive, searchable format. For further assistance contact GrantsInfo, Telephone 301/435-0714, Email: GrantsInfo{at}nih.gov.
Deadline: Letter of Intent Receipt Date: February 14, 2002. Application Receipt Date: March 21, 2002.