eCancer Consult, July, 2012

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First Privately Funded MDS Research Consortium in the U.S. Launches

Mikkael Sekeres, MD, Director of Taussig Cancer Institute’s Leukemia Program, will co-chair the Consortium with Guillermo Garcia-Manero, MD, of MD Anderson Cancer Center

Taussig Cancer Institute will assume a key role in a six-institution consortium designed to conduct clinical trials and research to improve outcomes for patients with myelodysplastic syndrome (MDS). Known as the MDS Clinical Research Consortium, the five-year, $16 million initiative is sponsored by the Aplastic Anemia & MDS International Foundation and supported by the Edward P. Evans Foundation.

This is the first privately funded MDS research consortium in the U.S. Mikkael Sekeres, MD, Director of Taussig Cancer Institute’s Leukemia Program, will co-chair the Consortium with Guillermo Garcia-Manero, MD, of MD Anderson Cancer Center.

Centralized clinical operations (data collection and management, biostatistics, clinical trial accrual and supervision of research protocols) will be housed at Quantitative Health Sciences at Taussig. A portion of the grant will be set aside to fund this function.

The Consortium will be administered by the Aplastic Anemia & MDS International Foundation.

Programs selected as part of the Consortium are based at U.S. academic medical centers that serve a high volume of MDS patients; that maintain a current and historical patient data base; and that have a current and retrospective MDS patient cohort of sufficient size to have a very significant track record of participation in MDS-related clinical trials.

The other five participating institutions are the Dana Farber Cancer Institute; MD Anderson Cancer Center; H. Lee Moffitt Cancer Center and Research Institute; Weill Medical College of Cornell University; and the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

The Consortium will fill a major gap in MDS-related clinical research by providing a new “critical mass” of dedicated institutions to support the evaluation of promising new therapies, epidemiological studies, and translational studies leading to new treatments and classifications for these diseases. It will also sponsor a yearly, dedicated MDS fellowship slot at each institution.

“This Consortium is the first clinical research network created to support the infrastructure that makes MDS clinical research happen by enabling the collaboration of the leading MDS centers is the U.S.” says Dr. Sekeres.

“One of the greatest challenges in research of rare diseases like MDS is having enough patients to conduct meaningful clinical trials. No single center can do it alone. This uniquely collaborative effort overcomes that barrier,” says John Huber, Executive Director of the Aplastic Anemia & MDS International Foundation. “To have these six leading MDS research centers working together in this way is unprecedented.”

Cleveland Clinic Takes Leadership Role in HPV Associated Head and Neck Clinical Trial

Biological differences in HPV-positive Head and Neck Cancers Requires New Treatment Considerations. With cure rates exceeding 90 percent, and infected patients being younger and healthier, oncologists are focusing on therapies with fewer long-term side effects.

The past decade has seen a dramatic shift in the etiology of squamous cell carcinomas (SCC) of the oral cavity, larynx and pharynx, from tobacco use, smoking and excessive alcohol consumption to infection with the human papillomavirus (HPV), most commonly HPV 16. More than 70% of oropharynx cancer patients at Cleveland Clinic now have HPV-associated disease, and they are primarily younger, healthier, non-smoking adults.

“We anticipate that human papillomavirus-associated oropharynx cancer is going to be the most common HPV-associated cancer in the United States within the decade,” says David J. Adelstein, MD, Solid Tumor Oncology.

This trend is changing the way these diseases are treated. Traditional treatment regimens often produce long-term toxicities, functional compromise and impaired quality of life. But HPV-associated oropharynx cancers are biologically different from their HPV-negative counterparts and respond better to treatment. In non-smoking patients, cure rates in excess of 90 percent are common.

Cleveland Clinic has responded by taking a leadership role in conducting clinical trials aimed at identifying less-toxic treatments that do not compromise results for patients with HPV-associated oropharynx cancers. One national phase III trial currently under way is comparing cisplatin and radiation therapy with radiation therapy and cetuximab, a monoclonal antibody directed against the epidermal growth factor receptor.

“We expect survival to be excellent with both treatments. The clinical trial will allow us to assess the extent to which targeted bioradiation may reduce toxicity and improve swallowing function and quality of life, compared with conventional chemoradiation,” says. Dr. Adelstein, who is a study co-chairman.

HPV-negative disease

On the flip side, HPV-negative oropharynx cancers have a poor prognosis, despite aggressive chemotherapy and radiation therapy. While clinicians have been reluctant to consider surgical resection in these patients because of the functional and cosmetic consequences, robotic and other transoral surgical approaches are showing promise in obtaining excellent local disease control with minimal functional impairment.

The question is whether adding minimally invasive surgery to radiation and chemotherapy can improve the success rate in patients with HPV-negative cancers.

“Even if chemoradiation therapy is necessary following robotic surgery, a less intensive course may be possible. We are developing clinical trials to test this hypothesis,” says Dr. Adelstein.

Taussig Cancer Institute Clinical Trials

Taussig Cancer Institute provides world-class care to patients with cancer and is at the forefront of new and emerging clinical, translational and basic cancer research. Taussig annually enrolls over 1300 patients in over 240 clinical trials.

Please read more about our featured trials this month:

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Clinical Trials

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