Recruiting Minorities for Cancer Trials
words by mary ann littell /
photographs by pete byron
Robert Wieder, MD, PhD, director, clinical research office, UMDNJ-New Jersey Medical School/University Hospital Cancer Center
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ur goal is to bring high-quality clinical trials to residents of Newark and surrounding communities,” says Robert Wieder, MD, PhD. “While some 4 to 5 percent of all cancer patients participate in clinical studies, only 2 percent of minority patients participate. The lack of minorities in research studies contributes to inequalities in healthcare.”
The UMDNJ-New Jersey Medical School/ University Hospital Cancer Center was launched in Newark two years ago to fill a void in cancer care in this area. The center has formed collaborative agreements with nine National Cancer Institute (NCI)-approved cooperative groups. NJMS faculty serve as on-site principal investigator liaisons for each group, and nine disease-specific tumor boards meet regularly to discuss patient care. Last year, physicians at the center treated some 1,100 new patients for a variety of cancers; more than 60 percent were minorities.
The Clinical Research Office and its dedicated staff serve as a core facility for the investigators of the cancer center community and currently support 45 ongoing clinical trials, including 12 for breast cancer, an area of special interest to Wieder. “These include protocols for breast cancer patients in the adjuvant setting and for those who have relapsed or have metastatic disease,” he says. “One novel protocol tries to predict relapse of cancer by counting circulating tumor cells. A quality of life protocol is designed to prevent ovarian failure in young breast cancer patients who wish to preserve fertility. Another trial for post-menopausal women with estrogen sensitive cancers compares the effectiveness of hormone therapy with chemotherapy in blocking cancer growth.”
Recruiting minority patients for clinical trials can be challenging, says Wieder. “Many of them are poor with no health insurance, and have transportation, child care and language issues,” he explains. “Also, they don’t know much about clinical trials. So it’s our job to educate them.”
With a grant from the Susan G. Komen For the Cure of Northern New Jersey, the center has launched several educational initiatives for patients. Funds from this grant support a patient navigator to deal solely with breast cancer patients. “From the time of the initial diagnosis, the patient navigator meets regularly with patients,” says Wieder. “The goal is to give them the information they need to make an informed decision about entering clinical trials. And once they have the facts, most patients do want to participate.”
The Komen grant also supported the development of a 14-minute training video, “Cancer Clinical Trials: Having a Choice.” The video features breast cancer patients talking about their experiences participating in clinical trials. It is shown to all patients who are diagnosed with breast cancer and referred for treatment at the center. “Through these and other initiatives, we’ve increased participation in NCI-sponsored clinical trials while offering extraordinary care to our patients,” says Wieder.
Chemoradiotherapy Saves Lives
Charles Cathcart, MD, director, radiation oncology, UMDNJ-New Jersey Medical School (NJMS)
The combination of chemotherapy and radiation — called chemoradiotherapy — has improved cancer care dramatically, says Charles Cathcart, MD. As director of the oncology committee at NJMS, he is involved in clinical trials for all types of cancer.
“We see many rare tumors here,” he says. “Patients are referred to us because of our expertise, particularly in the areas of musculoskeletal, head and neck, and liver cancers. About one-third of the patients we treat have been diagnosed with head and neck cancers. They would probably only be 5 percent of a typical practice.
“Clinical trials for these cancers are complex and not many centers can run them,” he continues. “The reason we’re able to do it is not only because of our physicians. It’s everything else we offer — particularly our highly skilled nursing care.” The radiation oncology team includes another radiation oncologist, Dolly Razdan, MD, as well as nurses, therapists and physicists.
Cathcart’s interest in clinical trials and radiation oncology goes back to his medical school days. He holds an undergraduate degree in mathematics and entered his field because of its unique combination of math and medicine. “I find great satisfaction in taking care of cancer patients,” he says. “As a group, they’re very brave. They’ve gotten the worst news a doctor can give, and they’re open to trying new therapies. It’s also satisfying to bring promising experimental treatments to minority and underserved patients, who often don’t have access to them.”
Cathcart, along with Razdan, oversees several protocols sponsored by the Radiation Therapy Oncology Group, a national clinical cooperative group conducting clinical trials. One is a Phase III trial for head and neck cancer patients, combining radiation with cisplatin and Erbitux. The trial, which randomizes what kinds of chemotherapy are given during radiation treatment, aims to decrease the amount of time needed for treatment. “The treatments are very toxic,” he says. “We believe that if you can really hit the tumor hard in a shorter time frame, you’ll have a better chance of eradicating the cancer.”
A second study he’s involved with is a Phase II trial for patients with brain tumors. “We see approximately 40 to 50 malignant brain tumors a year — a very high number,” he says. “This study compares post-operative radiation therapy using different combinations of the chemotherapy drugs Temodar and gadolinium.”
Cathcart and a colleague, Denise Fyffe, PhD, have also conducted their own studies of 290 patients treated with radiation therapy and evaluated for compliance to prescribed treatment. Among those found more compliant: retired individuals over those who are working or unemployed; palliative patients over those who are curative; and patients who suffered no side effects over those who experienced side effects. “More studies are needed, but we hope to develop a model to help us identify which patients will be compliant, and therefore, good candidates for clinical trials, and which will not,” he says. “Such a model would help us better allocate our healthcare dollars.”
Strong Medicine
Margarette Bryan, MD,
assistant professor of medicine-hematology and oncology, UMDNJ-New Jersey Medical School (NJMS)
The flip side of chemoradiotherapy — chemotherapy — is the domain of Margarette Bryan, MD. A native of the West Indies, the oncologist began her medical career in Jamaica and did her residency in internal medicine in Washington, DC. She came to NJMS in 1991 to do a fellowship in hematology/oncology and stayed.
Caring for cancer patients is Bryan’s passion. “We meet patients every day with different needs, different diseases. It is a challenge,” she says. She is part of a team that includes five general oncologists. They don’t focus on a specific cancer, but plan and oversee the chemotherapy for a variety of diseases. “We’re serving a community that has a lot of pathology. While some come in with very advanced cancer, we’re able to help many patients with state-of-the-art therapies.”
She recalls one patient, 28 years old and four or five months pregnant, with fairly advanced Hodgkin’s disease. “She was very sick,” says the physician. “A mass in her chest was so large that it was compressing her lungs and obstructing her breathing. We did a lot of research and had many discussions to see what would be the best treatment for her and presented the least risk to her baby. She came through it very well, and so did the baby — a little girl. She’s a few years old now, and the mother is still doing well.”
Bryan is the recipient of the 2009 Clinical Faculty of the Year Award, given by the NJMS faculty. She was recognized by her peers for her outstanding contributions to the medical school, where she is involved with several trials for gynecologic, breast and urodigestive tract cancers. One, a national Phase II trial for breast cancer, involves various chemotherapy drugs, including epirubicin plus cyclophosphamide followed by docetaxel plus trastuzumab and bevacizumab.
Another new trial is investigating the use of temozolomide, an approved therapy for malignant brain tumors that is being studied in other cancers. “This trial was originally launched for colorectal, lung and esophageal cancers, but now it is focused only on esophageal cancer, because that is where it’s showing some promise,” she says. The trial is sponsored by Schering-Plough.
Bryan says the most compelling aspect of doing this work is the appreciation from patients and their families. “Saving lives is very satisfying,” she says. “But too many people are dying of cancer, so clearly we have not hit a home run when it comes to cancer management. That’s why clinical trials are so important. Without them, we’ll never advance in cancer treatments.”