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Winthrop Launches New Clinical Trial for Glioblastoma Patients

Working together to try to improve outcomes and quality of life for patients with a glioblastoma (a common, malignant brain tumor), a group of Winthrop physicians from areas including neurooncology, radiation oncology and wound care recently joined forces to develop a cutting-edge clinical trial. The trial offers an innovative treatment protocol that utilizes Winthrop’s unique ability to deliver hyperbaric oxygen therapy, used in wound care, in rapid succession with radiation therapy.

Prior studies showed that when glioblastoma cells were treated with hyperbaric oxygen within 20 to 30 minutes of radiation, they became more sensitive to radiation therapy.

Knowing that Winthrop’s state-of-thescience Hyberbaric Medicine Program was located right down the hall from the Hospital’s Radiation Oncology Center, Winthrop neuro-oncologists J. Paul Duic, MD, and Jai Grewal, MD, saw an opportunity to offer the innovative combination of therapies to patients who are suffering from this particularly aggressive type of brain cancer.

Drs. Duic and Grewal teamed up with Scott Gorenstein, MD, Clinical Director of Winthrop’s Hyperbaric Medicine Program, and Jonathan Haas, MD, Associate Director of Radiation Oncology at Winthrop, to develop a clinical trial to treat glioblastomas (GBMs).

“Glioblastomas are among the most common brain tumors that we treat – yet, they are also the most aggressive,” said Dr. Haas.

For years, Winthrop’s multidisciplinary cancer care team has addressed the medical needs of every glioblastoma patient, offering comprehensive surgical, medical and support services. Yet, despite advances in neuroscience techniques and radiation oncology over the years, the median survival rate for patients remains approximately one year.

Dr. Duic and Dr. Grewal, who are the Principal Investigators of this Phase II clinical trial, have extensive research experience, having conducted clinical trials for the National Institutes of Health (NIH). Dr. Duic and Dr. Grewal worked with the Hospital’s Institutional Review Board (IRB) to obtain protocol approval in order to make it available to newly diagnosed GBM patients. The trial began in June 2009 and to date four patients have begun treatment.

“We have brought a unique clinical trial to the community and are offering a service to Long Island residents who would otherwise have to travel to New York City or even out of state for this treatment,” said Dr. Duic.

The trial involves six consecutive weeks (30 treatments) of oral chemotherapy (Temodar®), radiation therapy, and hyperbaric oxygen therapy (HBOT). Patients undergo HBOT for 30 minutes prior to undergoing radiation therapy – which typically ranges from five to 15 minutes.

During HBOT, the patient breathes 100 percent oxygen while reclining in a pressurized chamber. Inhaling the pure oxygen allows greater amounts of oxygen (up to 10 times more than what is possible while breathing oxygen at sea level pressure) to be absorbed into the bloodstream and then carried to body tissues.

“Studies have shown that severe hypoxia – lack of oxygen – within tumor cells can influence their unresponsiveness to radiation and chemotherapy.

Administering hyperbaric oxygen therapy prior to radiation can increase oxygen levels in the blood and tumor, making it more sensitive to radiation,” said Dr. Gorenstein.

“For most patients there is usually no discomfort associated with HBOT and patients can rest, watch TV or movies, or sleep during treatment,” added Dr. Gorenstein.

Following HBOT, the patient is quickly transferred from the Hospital’s Hyperbaric Center to the Radiation Oncology Center for the next phase of treatment.

“Winthrop-University Hospital has a unique advantage when compared to other centers around the nation,” said Dr. Haas. “Winthrop’s Radiation Oncology Center and hyperbaric oxygen therapy facility are in close proximity to each other. This is vital as radiation therapy should be administered within 15 minutes of HBOT in order to maximize the benefits of this added therapy.”

Upon completing six weeks of chemotherapy, radiation and HBOT, patients have a four week respite after which they begin adjuvant chemotherapy under close supervision of their team of physicians.

“It is exciting that Winthrop- University Hospital is equipped with the resources we need to offer this treatment. We have had patients and researchers contact us from around the country with an interest in this clinical trial,” said Dr. Grewal.

It is the hope of these Winthrop physicians that the addition of HBOT will not only redefine the current standard of care for newly diagnosed GBM patients, but will also positively impact patients’ quality of life and median survival rates.

“Glioblastoma is a deadly disease, but if we can use a beneficial therapy such as hyperbaric oxygen therapy to improve patient outcomes, then we are doing a great service to our patients,” said Dr. Haas.

For more information on how to enroll in this clinical trial, please call 1-866-WINTHROP.
Vol. 19, No. 3
Fall 2009

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