Developmental Therapeutics Section
Medical Oncology Branch
Mission
The overall mission of the Developmental Therapeutics Section is to evaluate promising novel anticancer drugs in early phase clinical trials, while providing outstanding clinical care for patients with different types of cancer. An important focus of the Section is first-in-human clinical trials, particularly those that incorporate pharmacodynamic and pharmacokinetic endpoints, with the goal of informing subsequent clinical development.
Overview
The Developmental Therapeutics Section (DTS) and clinic were established in November 2005 as part of a joint initiative between the NCI Center for Cancer Research (CCR) and Division of Cancer Treatment and Diagnosis (DCTD) to enhance the Institute's drug development effort. The major focus of the DTS is to design and conduct first-in-human and other early phase clinical trials of investigational agents. The DTS team consists of clinical investigators who are board certified in internal medicine and medical oncology, fellows, research nurses, and nurse practitioners. The DTS team also consists of clinical assistants, data managers and a social worker. As a team, DTS is dedicated to conducting clinical trials based on sound translational research, while providing the highest possible clinical care for patients with various types of advanced malignancies.
The trials that DTS develops and conducts involve safety assessments, pharmacokinetics, and complex pharmacodynamic laboratory correlatives, including tumor target and biomarker assay development. DTS works in close collaboration with other clinical and laboratory investigators within CCR and DCTD, including the Developmental Therapeutics Program (DTP) and the Cancer Treatment Evaluation Program (CTEP). In addition to first-in-human phase I trials, DTS conducts other phase I and II trials of novel agents, used alone and in combination, and provides specialized consultative service for other CCR and NIH programs.
Investigator
James H. Doroshow, M.D.
Director and Senior Investigator
Division of Cancer Treatment and Diagnosis,
Laboratory of Molecular Pharmacology, NCI
Dr. James H. Doroshow has been Director of the Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI), National Institutes of Health (NIH), since 2004. From 1983 to 2004, Dr. Doroshow was the Associate Director for Clinical Research at the City of Hope (COH) Comprehensive Cancer Center in Duarte, Calif; the Chairman of the COH Department of Medical Oncology and Therapeutics Research; and the Leader of the COH Cancer Center's Clinical and Experimental Therapeutics Program.
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Shivaani Kummar, M.D., F.A.C.P.
Section Head, Developmental Therapeutics Section
Head, Early Clinical Trials Development,
Office of the Director,
Division of Cancer Treatment and Diagnosis
Medical Oncology Branch, NCI
Dr. Kummar received her medical degree from Lady Hardinge Medical College, New Delhi, India, and her internal medicine residency training from Emory University, Atlanta, Ga. Upon completion of her fellowship training in medical oncology and hematology from the National Institutes of Health, Bethesda, Md., she joined Yale Cancer Center, Yale University, New Haven, Conn., as an assistant professor in medical oncology. Dr. Kummar is currently the head of the Developmental Therapeutics Clinic at the National Cancer Institute, where she focuses on early drug development in oncology.
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