FOR IMMEDIATE RELEASE: Feb. 23, 2004
Contact: Karen E. Warmkessel kwarmkessel@umm.edu
Ellen Beth Levitt eblevitt@umm.edu 410-328-8919

UNIVERSITY OF MARYLAND CANCER SPECIALISTS STUDY NEW TREATMENT DELIVERY SYSTEM FOR AGGRESSIVE BRAIN CANCER

Novel approach allows doctors to send timed-release chemotherapy directly to the tumor

This novel approach for treating brain cancer delivers chemotherapy directly to the tumor through a catheter -- shown here, connected to the reservoir -- implanted in the brain.

As part of a multi-center clinical study in the United States and Canada, oncologists at the University of Maryland Greenebaum Cancer Center are treating one of the most aggressive forms of brain cancer with timed-release chemotherapy delivered directly to the tumor through a catheter implanted in the brain. The catheter, which is connected to a reservoir placed underneath the scalp, enables doctors to bypass the protective barrier around the brain, which usually blunts chemotherapy’s effectiveness in treating brain cancer.

"This new approach delivers a much higher concentration of chemotherapy to the tumor site than larger doses of the drug injected into the bloodstream, without the debilitating side effects," says William F. Regine, M.D., chief of radiation oncology at the University of Maryland Medical Center and professor and chairman of the Department of Radiation Oncology at the University of Maryland School of Medicine.

 Dr. Regine is a co-principal investigator and the lead radiation oncologist in a Phase II trial of this new treatment for rapidly growing brain tumors called glioblastomas. The study is being conducted at more than 30 medical institutions in the United States and Canada. The University of Maryland Greenebaum Cancer Center is the only site in Maryland and the Washington, D.C., area to offer the new treatment. Dr. Regine was previously part of a team at the University of Kentucky that developed the approach and conducted a Phase I clinical study.

"Treating glioblastomas with intravenous chemotherapy has not been very effective because of what is known as the blood-brain barrier-- the network of tightly sealed blood vessels that prevents many substances from passing into the brain," Dr. Regine explains.

"With this novel approach, we are able to circumvent the brain's natural defense system and inject a powerful chemotherapy drug directly into the tumor. Patients tolerate this treatment very well and are much less likely to suffer from the nausea, vomiting, hair loss and increased risk of infection often caused by intravenous chemotherapy."

Dr. Regine says that the chemotherapy drug, bleomycin, has been shown to be effective against brain tumors in experimental models, but has not been used to treat patients because of poor absorption due to the blood-brain barrier and severe side effects when it is administered intravenously.

The Phase I study conducted at the University of Kentucky determined that the "intratumoral" chemotherapy with bleomycin was safe for patients. The Phase II national/international trial will test the effectiveness of the drug and the new delivery system after patients have completed a course of radiation therapy.

The University of Maryland Greenebaum Cancer Center began treating its first patient, a 71-year-old Eastern Shore woman, with this new approach in late December.

Glioblastoma multiforme (GBM) is the most common and aggressive form of primary brain cancer. "It is one of the most aggressive cancers that you can have," Dr. Regine says, noting that it typically recurs and branches out into other areas of the brain despite treatment with a combination of surgery, radiation and chemotherapy.

Without treatment, half of the patients diagnosed with the fast-growing cancer die within three months, Dr. Regine says. Even with surgery, radiation and chemotherapy, the median survival is less than a year. Researchers hope that this new approach will boost the effectiveness of chemotherapy and improve patients' survival rate and quality of life. In the Phase I clinical study, patients who had recurrent cancer that did not respond to prior treatment received timed-release chemotherapy alone via the new delivery system and had a median survival of six and a half months, with two of the nine patients living more than a year.

Patients who participate in the new study will have surgery to remove as much of their tumor as possible, followed by radiation treatments five days a week for six weeks. Using powerful three-dimensional computer imaging technology, surgeons at the University of Maryland Greenebaum Cancer Center will then implant the catheter in the brain, connecting it to a refillable reservoir placed underneath the scalp. The device has a cellophane-like semi-permeable membrane that regulates the flow of the chemotherapy drug.

Patients receive chemotherapy once a week for up to two years, with the drug injected into the reservoir underneath their scalp. A medical oncologist supervises the weekly treatments. The study is an example of the University of Maryland Greenebaum Cancer Center’s multidisciplinary approach, with radiation oncologists, surgeons, medical oncologists and other specialists working together to develop treatment plans for patients.

The research is being conducted under the auspices of the Radiation Therapy Oncology Group, a national clinical research cooperative funded by the National Cancer Institute. Researchers hope to enroll 72 patients in the study in the United States and Canada.

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