Cancer Centers Seek Greater Enrollment in Early Clinical Trials

Researchers from National Cancer Institute (NCI)-designated Cancer Centers met in Denver last month to share preliminary findings from seven pilot studies aimed at increasing participation in early phase clinical trials, particularly among elderly and underserved populations.

The meeting was the third workshop organized under the 2003 NCI-led initiative, "Overcoming Barriers to Early Phase Clinical Trials." The workshops allow grantees to exchange ideas on why certain groups do not join phase I and II clinical trials and what can be done about it.

"We are looking at a variety of different approaches for overcoming barriers, and it's important to say at this point that the initiative is still a work in progress," said Dr. Edward Trimble of NCI's Division of Cancer Treatment and Diagnosis. Among the strategies being tested are the use of counselors to guide patients through the clinical trials process, community education programs, and equipping oncologists with Personal Digital Assistants (PDAs) so they can identify open trials during office visits with patients.

Early phase clinical trials determine which agents enter the clinical pipeline and are eventually tested in larger studies. Different groups may respond to treatments differently, so broad participation in early trials is critical. For example, the lack of participation among patients over the age of 65 - many of whom may take several medications - could pose a public health challenge in the years ahead.

"The population is aging, and we need to do a better job defining the appropriate doses and toxicity of the agents we use to treat cancer," said Dr. Michele Basche of the University of Colorado Health Services Center. Her team found that logistical barriers, such as transportation, often prevent older patients from joining trials.

The "Overcoming Barriers" initiative was launched 18 months ago as a public-private partnership supported by NCI; the Association of American Cancer Institutes; Friends of Cancer Research; the Foundation for the National Institutes of Health (NIH); and five pharmaceutical companies: Aventis, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, and Novartis.

During the project's planning stages, NCI-designated Cancer Centers were the obvious choice to carry out the initiative, according to Dr. Linda Weiss, chief of NCI's Cancer Centers Branch. "The Centers are really a clinical trials powerhouse because they have strong links to local communities and also to drug companies and NCI," she said.

NCI-designated Cancer Centers provide the majority of patients for NCI clinical trials, and they "certainly provide a large measure of intellectual leadership in our clinical trials program," noted Dr. Trimble. "NCI relies heavily on the doctors, nurses, and data managers in our Cancer Centers to help conduct trials."

The "Overcoming Barriers" initiative is funding projects at Baylor College of Medicine; Ohio State University; Massachusetts General Hospital; Washington University, St. Louis; University of California, Davis Cancer Center; University of Colorado Health Services Center; and University of Pittsburgh Cancer Institute.

The initiative may be extended beyond its originally scheduled end date of August 2005. Final results and recommendations will be reported at major scientific meetings and disseminated through the popular press and scientific literature.

By Edward R. Winstead

Bringing Health and Hope to Us All

In this issue of the Bulletin, we celebrate the NCI Cancer Centers Program and the 60 institutions it currently funds. It's impossible to capture the program's history and spirit in 8 pages and a few thousand words, but I hope you'll come away understanding how important the Cancer Centers are in supporting NCI's mission.

It's been 35 years since the Yarborough Committee - a panel of medical and policy experts convened by the Senate committee chaired by Sen. Ralph W. Yarborough (D-Texas) - recommended that Comprehensive Cancer Centers serve as a focal point to speed progress in a new, coordinated assault on cancer. President Nixon signed the National Cancer Act 1 year later, and many of us have spent untold hours attempting to achieve the noble goal set forth in that law.

The National Cancer Act significantly altered the cancer research landscape. In particular, it changed how NCI interacts with outside research institutions, granting NCI new authorities that, in effect, have built an oncology clinical research infrastructure that supports advanced biomedical technology development and is characterized by scientific excellence.

By 1976, when I began my fellowship in urologic oncology at M.D. Anderson Cancer Center, the law's early impact was already being felt: 19 Cancer Centers were designated as "comprehensive," P30 core grants were established, and the program had a budget of approximately $47 million. When I arrived at NCI 26 years later, the program had blossomed, with a P30 budget of $201 million and rising interest in achieving Cancer Center designation among medical research institutions across the country.

Now, after 3 years as NCI director, I've had the fortune to visit a number of NCI-designated Cancer Centers and I am always impressed by their talented research personnel and the unequaled services their medical and support staffs provide. Each center is unique, but all push the standard of patient care to a higher level. Some, for example, are offering robotic surgery, a minimally invasive tool that can improve the surgeon's ability to excise tumors while also reducing side effects. Others have launched survivorship centers that offer psychosocial and other support services.

I have been particularly impressed with Cancer Centers' eagerness to work more closely with NCI on initiatives. The cancer Biomedical Informatics Grid (caBIG) is an ideal example. Most of the Cancer Centers are taking part in developing what I believe will be a revolutionary tool in accelerating the pace and efficiency of cancer research. And in May, Cancer Center directors will meet for the second year in a row to discuss with NCI leadership future opportunities and challenges for their centers in the National Cancer Program.

I have also seen how Cancer Centers affect the people and institutions around them. Whether conducting outreach to underserved minority groups, sponsoring educational courses about cancer prevention, or partnering with local biotech companies on cutting-edge research, NCI-designated Cancer Centers represent an important thread in the fabric of our nation's cancer community.

Each Cancer Center is unique, but they all share one very important attribute: compassionate staff who work diligently toward the goal of transforming this disease from one that debilitates and kills to one that can be identified early and ameliorated. Across the country, in laboratories, hospitals, and public education venues, these people are the hands, the hearts, and the minds that are fulfilling NCI's mission and bringing health and hope to all of us. My sincerest gratitude to all of our Cancer Center colleagues for the tremendous work you do every day.

What determines the overall number of Cancer Centers funded by NCI?
The original intent of Congress was to have a center within 200 miles of every U.S. resident, enhancing the application of cancer discoveries to patients and people at risk. As a consequence, NCI has never set limits on their number. An applicant must achieve a meritorious priority score in peer review to be funded. Obviously, the NCI budget also has some effect, but we've always supported the funding of outstanding new centers, even in times of budget constraints.

Can any institution that conducts cancer research become an NCI-designated Cancer Center?
In theory, yes, but the requirements are steep: a large cancer-relevant grant funding base; substantial institutional commitment in the form of space, resources, and authorities provided to the Center director; organization of transdisciplinary research across all scientific areas of the institution to "make the whole greater than the sum of its parts;" and, specifically for comprehensive centers, community outreach, education, and training activities. The average NCI grant base for existing centers is somewhere around $11 million, so that gives you an idea of the critical mass of research required.

What impact do the guidelines issued last year have on Cancer Centers?
The new guidelines were partly a response to recommendations made to NCI by the P30/P50 Ad Hoc Working Group Report, but we also introduced formatting changes and some templates to standardize data submissions. The guidelines just went into effect on February 1 and it'll take several application cycles before we can assess their impact.

How would you summarize the contribution that Cancer Centers make to the overall cancer community?
When you combine NCI awards with the number of grants received from other NIH institutes and sponsors, centers have significant resources to leverage against the cancer problem. They also have an environment that fosters basic discovery and its translation into cancer treatment, prevention, and control activities; and the ability to network both within their community and with each other, so there's extraordinary research power.

Over time, they've been variously described as the "jewels in the NCI crown," and the "ships of the line" and these descriptions are very fitting. Their contributions have been enormous and we see them continuing to escalate in the future.

Cancer Center Web Sites: Another Way to Locate Clinical Trials

Patients and clinicians who are searching for clinical trials can use several resources, including NCI's PDQ database (http://cancer.gov/clinicaltrials/search) and Cancer Information Service (1-800-4-CANCER), as well as the NIH's ClinicalTrials.gov database (http://www.clinicaltrials.gov), which is managed by the National Library of Medicine.

Another way to search for clinical trials - one that may be more practical, in some cases - is by searching the NCI-designated Cancer Centers' Web sites directly.

More about locating clinical trials at NCI-designated Cancer Centers can be found at: http://cancer.gov/clinicaltrials/finding/NCI-cancer-centers/map. Patients or family members should note that the summaries describing these opportunities may be written in technical language and should be shared with a health care provider before making a decision about enrollment in a trial.

Bevacizumab Prolongs Survival for Some Patients with Advanced Lung Cancer Preliminary results from a large, randomized, NCI-sponsored clinical trial for patients with previously untreated advanced non-squamous, non-small cell lung cancer show that those who received bevacizumab (Avastin) with standard chemotherapy lived longer (median survival 12.5 months) than patients who received the same chemotherapy without bevacizumab (median survival 10.2 months). This difference is statistically significant. More information can be found at http://cancer.gov/newscenter/pressreleases/AvastinLung.

Patients and clinicians who are searching for clinical trials can use several resources, including NCI's PDQ database (http://cancer.gov/clinicaltrials/search) and Cancer Information Service (1-800-4-CANCER), as well as the NIH's ClinicalTrials.gov database (http://www.clinicaltrials.gov), which is managed by the National Library of Medicine.

Another way to search for clinical trials - one that may be more practical, in some cases - is by searching the NCI-designated Cancer Centers' Web sites directly.

More about locating clinical trials at NCI-designated Cancer Centers can be found at: http://cancer.gov/clinicaltrials/finding/NCI-cancer-centers/map. Patients or family members should note that the summaries describing these opportunities may be written in technical language and should be shared with a health care provider before making a decision about enrollment in a trial.

Bevacizumab Prolongs Survival for Some Patients with Advanced Lung Cancer Preliminary results from a large, randomized, NCI-sponsored clinical trial for patients with previously untreated advanced non-squamous, non-small cell lung cancer show that those who received bevacizumab (Avastin) with standard chemotherapy lived longer (median survival 12.5 months) than patients who received the same chemotherapy without bevacizumab (median survival 10.2 months). This difference is statistically significant. More information can be found at http://cancer.gov/newscenter/pressreleases/AvastinLung.