CCR At a Glance

NIH Clinical Research Center Building

Distinctive Attributes of CCR's Clinical Research Program

• Integrate basic and clinical research to accelerate translation of advances to benefit patients
• Integrate preclinical cancer models and methods with early clinical development
• Discover and develop molecularly targeted agents and combinations of agents
• Conduct concept-based (science-driven) clinical trials to evaluate new therapies rather than test existing ones
• Develop and deliver novel technologies
• Study rare diseases and underserved cancers
• Provide translational research training

The NCI Intramural Clinical Research Program

• CCR's intramural clinical research program is far-reaching and active, accounting for 40 percent of the total medical effort at the NIH Clinical Research Center.
• The NIH Clinical Research Center has 242 in-patient beds, 90 day-hospital stations, and multiple outpatient clinics where patients are treated in intramural clinical trials.
• The CCR clinical program treats approximately 4,000 to 5,000 patients per year in 200 studies, enrolling 800 new patients each year.
• Patients are seen in inpatient, outpatient, and day-hospital settings.
• Research activities are multidisciplinary, spanning oncologic diseases from lung, prostate, colon, and breast cancers, as well as lymphoma, to understanding rare cancers and diseases. Research also develops new treatment approaches in transplantation, surgery, radiation, and immunotherapy.

Types of Clinical Trials

The majority of CCR’s trials at the NIH Clinical Center study new treatments.

Treatment Trials by Phase

The majority of CCR’s early-phase studies, from pre-Phase I (preIND) through Phases I and II, are proof-of-principle trials that answer some of the basic questions about optimizing a new drug’s dose, safety, and mode of delivery.

Early-Phase Clinical Trial Pipeline

Center for Cancer Research and Division of Cancer Treatment and Diagnosis

Many CCR components feed into early-phase clinical trials.

Clinical Partnerships

CCR’s clinical researchers collaborate broadly with many external researchers. Their pooled expertise ensures that innovative findings and technologies are rapidly dispersed throughout the cancer research community.

Examples include:

• HPV Research, Clinical Trials and Vaccine Development Partnership is a team of commercial and other government partners who will conduct surveillance in the U.S. post-HPV vaccine licensure.
• Trans-Institute Angiogenesis Research Program (TARP) is a multidisciplinary program for collaborative studies in angiogenesis and vasculogenesis. Partnerships include six NIH institutes and the Juvenile Diabetes Research Foundation International (JDRF). TARP and the CCR have partnered to open the Angiogenesis Core Facility, which supports preclinical studies and clinical trials.
• Hematopoietic Stem Cell Transplantation Partnership is a “Manhattan Project” approach to overcome the four primary barriers of transplant: graft rejection, graft versus host disease, tumor relapse, and lack of immune reconstitution. Includes extramural Cancer Center with relevant patient population.
• Lymphoma and Molecular Profiling Project is an international 10-institution collaboration to establish a molecular classification of human lymphoid malignancies and define molecular correlations of clinical parameters that are useful in prognosis and in the choice of optimal therapy.
• Glioma Molecular Diagnostics Initiative and REMBRANDT is a partnership that includes five National Cancer Institute branches, another NIH institute, two consortia, and three SPOREs. All collaborate to accrue 1,000 patients for a national study of gliomas that will correlate extensive prospective clinical data with molecular profiles. The CCR will make the pathological classification of gliomas available as a publicly accessible database with analysis tools.
• Partnership to Establish Standards for Chronic Graft versus Host Disease (GVHD) is a collaboration with 100 institutes worldwide to advance the standards of chronic GVHD.
• Breast Cancer Partnership is a research program on metastatic breast cancer to the brain that includes a CCR lab working with many extramural labs.
• Pediatric Oncology Partnerships with Children’s Oncology Group and Consortia is a team effort through which CCR’s pediatric oncologists conduct Phase I and II clinical trials at NIH and participate as a members of multiple clinical trials consortia, including the COG Phase I/Phase II Developmental Therapeutics Consortium, the Pediatric Brain Tumor Consortium, the Mycoses Study Group, and SARC, the newly formed clinical trials group for sarcomas.
• Cancer Vaccines Partnerships develop and analyze new recombinant vaccines and vaccine strategies. In addition to the NIH Clinical Center and the National Naval Medical Center, seven cancer centers and the Eastern Cooperative Oncology Group (ECOG) multi-center consortium are conducting collaborative clinical trials for these new vaccines.
• Therapeutic Immunotoxins Partnerships test therapeutic immunotoxins developed by CCR at centers nationwide. New antibodies to mesothelin have been humanized, licensed, and are in clinical studies at NIH and at two centers for mesothelioma and pancreatic cancer.
• HIV and AIDS-Related Agents Partnerships provided the historical support for research into oncogenic viruses, which led to the co-discovery of HIV as the cause of AIDS and the subsequent development of a diagnostic test in 1984. Many new vaccines and agents are currently being developed in collaboration with industry.
• Technology and Drug Development Partnerships enable academia and industry to partner with CCR and produce innovative technology and products such as: laser capture microdissection (LCM) to remove specific cells from microscopic tissue samples; spectral karyotyping to use computer-gathered light waves and assign each chromosome its own distinct hue; PPARa mouse models to study peroxisome proliferators-induced hepatocarcinogenesis; automated 3-D imaging; and over a dozen FDA-approved new drugs.
• Comparative Oncology studies naturally occurring cancer models in animals. Over a dozen veterinary universities have been invited to join the Comparative Oncology Trial Consortium.
• Local Oncology/Hematology Partnerships provide patients with easy access to CCR clinical studies. CCR and Associates in Oncology/Hematology (AOH) of Rockville have established a referral system to bring together AOH patients and CCR clinicians.
• International Partnerships benefit cancer patients around the world. In a partnership with the King Hussein Cancer Center in Amman, Jordan, CCR will address the prevalence of pediatric cancer in Iraq.
• National Naval Medical Center Partnership supports hematology–oncology subspecialty training for clinical fellows, facilitates collaborative clinical research, and improves access to NCI-sponsored clinical research trials for cancer by U.S. Navy and other Department of Defense (DoD)-eligible beneficiaries. Joint protocols developed have benefited the research efforts of both institutions over the years.
• Gastrointestinal Stromal Tumor Clinic brings together patients and national experts to evaluate treatment approaches for this rare disease and to develop an effective national clinical trial.

The Vision for the Future

The CCR is moving toward an era of personalized medicine in which each patient will receive the right therapy at the appropriate dose for the correct duration to best prevent, treat, or manage his or her specific cancer.

We will reach this era by:

• Blurring the line between imaging and pathology and improving imaging techniques to find lesions at the earliest point possible
• Identifying the molecular pathways and networks through which cancer signals, independent of the tumor’s tissue origin
• Disrupting pathways and networks using combinations of therapies to minimize toxicity and maximize therapeutic benefit
• Monitoring the patient with noninvasive imaging for reactivation of the tumor at the molecular level
• Intervening immediately using novel therapies developed and validated through CCR preclinical models followed by design and implementation of early-phase clinical trials