DIVISION OF CANCER TREATMENT AND DIAGNOSIS National Cancer Institute Cancer National PROGRAM ACCOMPLISHMENTS 2006 U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health TABLE OF CONTENTS Foreword . iii Division of Cancer Treatment and Diagnosis Overview . .1 Major Ongoing Initiatives and Accomplishments . .7 Biometric Research Branch Overview . 11 Partnerships and Collaborations . 12 Scientific Advances . 17 Other Biostatistical Research . 24 Tools, Products, and Resources . 27 Cancer Diagnosis Program Overview . 29 Major Ongoing Initiatives . 30 Current Funding Opportunities . 34 Partnerships and Collaborations . 36 Scientific Advances . 39 Tools, Products, and Resources . 41 Cancer Imaging Program Overview . 45 Major Ongoing Initiatives . 47 Current Funding Opportunities . 54 Partnerships and Collaborations . 57 Scientific Advances . 61 Tools, Products, and Resources . 63 Cancer Therapy Evaluation Program Overview . 65 Major Ongoing Initiatives . 67 Significant Ongoing Clinical Trials . 71 Current Funding Opportunities . 73 Partnerships and Collaborations . 75 Scientific Advances . 79 Tools, Products, and Resources . 92 TABLE OF CONTENTS ■ i Developmental Therapeutics Program Overview . 95 New Initiatives . 97 Major Ongoing Initiatives . .100 Current Funding Opportunities . .104 Tools, Products, and Resources . .105 History-Marking Event . .114 Scientific Advances . .115 Radiation Research Program Overview . .119 Partnerships and Collaborations . .121 Scientific Advances . .127 Tools, Products, and Resources . .129 Meetings and Workshops . .130 Meet the DCTD Staff . .131 ii ■ PROGRAM ACCOMPLISHMENTS 2006 FOREWORD ancer clinical research is changing, and a large part of Cthe transformation is being spearheaded by the Division of Cancer Treatment and Diagnosis (DCTD), an extramural component of the National Cancer Institute (NCI) with the responsibility of overseeing much of NCI’s infrastructure for clinical trials and drug development. I am pleased to provide you with this summary of accomplishments made possible by the many talented and dedicated staff members in programs throughout the division. Dr. James H. Doroshow, Director, NCI Division of Cancer Treatment and Diagnosis. Advances in molecular medicine have created new challenges for the design responsive, efficient, and innovative clini- and conduct of cancer clinical trials. The cal trials enterprise. The division will also National Cancer Advisory Board’s Clinical assist the newly created NCI Coordinat- Trials Working Group (CTWG) examined ing Center for Clinical Trials as it assumes these challenges and, last year, issued the day-to-day responsibilities for project 22 strategic initiatives to restructure the management of the CTWG initiatives. conduct of NCI-supported clinical trials so that new treatments reach patients with As part of the change process, DCTD cancer more quickly. The CTWG endorsed and the Center for Cancer Research team science in the broadest sense. This (CCR) are working in close collaboration included the development of mechanisms to reinvigorate cancer drug development to enhance the coordination of clinical, at NCI. Through a new, joint early thera- basic, and translational scientists in their peutics development program, extramural efforts to improve molecular diagnostic and intramural teams have prioritized a and imaging techniques, as well as to pipeline of NCI-driven targeted therapeu- increase the utility of novel targeted ther- tics for development. This program com- apies. The success of the CTWG initiatives bines the strengths of DCTD’s extensive will require a significant commitment by expertise in anticancer drug development all stakeholders in the clinical trials pro- with CCR’s dynamic in-house research cess to assist NCI in setting new policies, and its location within new state-of-the- procedures, and standards and in guiding art facilities at the NIH Clinical Research prioritization and decision-making. Center. This collaboration will also utilize a recent guidance from the U.S. Food and DCTD will play a leading role in the Drug Administration concerning explor- implementation of the CTWG initiatives, atory studies of investigational new drugs. with the goal of producing an integrated, FOREWORD ■ iii ■ ■ ■ The implementation of CTWG initiatives, modernization and DIVISION OF CANCER TREATMENT AND DIAGNOSIS integration of cancer therapeutics development, and expansion of the pipeline of potential cancer therapies underscore NCI’s position as a premier developer of novel cancer therapeutics and diagnostics. Clinical trials performed using an explor- tools that are in the public domain. These atory investigational new drug (IND) will complex tasks are time-consuming and facilitate targeted therapies entering expensive, and NCI is well suited to take early phase evaluation where the target on this enterprise. It is anticipated that can be carefully monitored. The goal of this investment will reap many benefits this new guidance is to safely shorten the by making a library of new molecular tools timeline for drug development. As part of available to all researchers in.