NCI Cancer Bulletin for May 18, 2010 - SPECIAL ISSUE

Additional Clinical Trials Resources

Cancer Clinical Trials at NIH

NCI supports cancer clinical trials across the country (U.S) through its extramural research program. Meanwhile, on NIH’s main campus, the Institute’s intramural researchers in the Center for Cancer Research (CCR) conduct hundreds of trials each year at the NIH Clinical Center in Bethesda, MD, and these trials often differ from those available elsewhere.
While some cancer centers also offer early-stage clinical trials, the difference is that CCR focuses almost exclusively on early-stage trials, said Dr. Bill Dahut, CCR’s clinical director.

NCI’s intramural program is able to pay the transportation costs for patients who are enrolled in Clinical Center trials. This allows CCR to see many more patients with rare cancers, or rare subtypes of common cancers, than other research sites because CCR can fly in patients from around the country to be treated in investigational studies.

One commonly cited barrier to entering clinical trials is the worry among both patients and their physicians of losing control. “An important point about treatment at NCI is that everything we do here for patients is done in close collaboration with their local physicians back home,” Dr. Dahut explained. “Our physicians provide expert clinical care to patients while they are being treated on protocol at NCI, but our physicians can see patients only while they are at the Clinical Center. Thus, continued care by local physicians is incredibly important to allow patients to access standard treatments or other trials not available here. Local physicians must remain closely involved with patients on NCI studies because side effects, from the cancer or the therapy, may occur when the patient is home and far from Bethesda.”

Patients and physicians interested in exploring cancer clinical trials at NIH can visit CCR’s clinical trials Web site. The site includes detailed descriptions of clinical trials currently recruiting patients; information for the general public about clinical trials and participating in trials at NCI; and information for health professionals about referring patients, the Center’s clinical programs and investigators, and ways to keep up to date with CCR research and opportunities.

“We’d really like to encourage physicians to join our mailing list,” said Susan McMullen, patient outreach and recruitment coordinator for CCR’s Office of the Clinical Director.  “One of the barriers to recruiting patients at NIH is that our doctors don’t have a patient base outside of clinical trials to draw from, so we rely on community doctors to refer patients to us.”

Family Cancer Registries

For some families, the tragedy and sorrow of losing a relative to cancer is repeated as family member after family member is diagnosed with the same disease.
To determine what genetic factors may be at work and how environmental influences alter those genetic risks, researchers rely on those affected by familial cancer to participate in family cancer registries.

“Our major goal in studying these families is to identify what are called high-risk susceptibility genes,” explained Dr. Peggy Tucker, director of the Human Genetics Program and chief of the Genetic Epidemiology Branch in NCI’s Division of Cancer Epidemiology and Genetics (DCEG). “We then try to understand the function of those genes, how they confer risk, and what other factors within the family modify risk.

“Ultimately, we want to be able to alter the risk of cancer in these families either by identifying susceptibility factors we can modify—for example, avoiding sun exposure in melanoma families—or designing interventions that can affect risk—such as prophylactic oophorectomy for women in families with high risk of both breast and ovarian cancer,” she said.

Family cancer registry studies can also help inform researchers about cancer susceptibility risks in the general population. For example, researchers identified dysplastic nevi as a major risk factor for melanoma by studying families at high risk of melanoma.

Researchers at NCI first began conducting family registry studies in the mid-1960s. These long-term studies follow families through successive generations, and allow researchers to examine the role of inherited high-susceptibility genes and cancer. Today, DCEG researchers are studying families with a number of inherited cancers or cancer-susceptibility syndromes, and researchers in NCI’s Division of Cancer Control and Population Sciences (DCCPS) sponsor the Breast and Colon Cancer Family Registries.

Whereas DCEG’s family registries are conducted at the NIH Clinical Center, the family registries based in DCCPS are found throughout the United States, Australia, and Canada. “Currently, we have about 78,000 men and women from nearly 26,000 families participating in these registries,” said Dr. Sheri Schully, program officer for the DCCPS family registries program. “The main objective of these registries is to identify and characterize cancer susceptibility genes, but the investigators also look at gene–gene and gene–environment interactions as well.”

Although family registry studies do not provide treatment to participating families, investigators often provide test results that can help family members learn which of them may be at higher risk because of certain susceptibility genes, such as mutations in the BRCA1 and BRCA2 genes or those associated with Lynch syndrome, said Dr. Schully.
Additionally, the studies are an opportunity for people who are often desperate for answers to ask questions.

“We like to think it’s a positive experience for them because they have a whole day at NIH to meet with physicians and nurses who know a lot about the disease,” Dr. Tucker explained. “We try to keep them updated with new findings about the diagnosis and management of the cancer that affects their family, and they know they can always come to us for referrals for care of the disorders that we’re studying.”

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