Doctors at the University of North Carolina at Chapel Hill are studying a new brain tumor treatment that could reduce both a patient's time in therapy and the side effects from radiation and chemotherapy. The three-step treatment for gliomas, a type of malignant brain tumor, combines surgery, radiation and chemotherapy in localized areas of the brain for the first time (actual treatment schema and eligibility requirements outlined at the bottom of the page). The treatment was developed by Dr. Matthew G. Ewend, Chief of Neuro-Oncology and Assistant Professor of Surgery, and Dr. Lav K. Goyal, Assistant Professor of Radiation Oncology. The treatment's aim is to improve quality of life by reducing treatment time and returning patients to their daily routines while providing aggressive glioma therapy. The study will last about two years; the hope, Ewend said, is to treat between 10 and 15 patients with this new method in the next year. UNC is one of only two centers in the United States using this new treatment. With the new treatment, patients first undergo surgery to remove as much of the tumor as possible. Then, doctors insert a balloon catheter which will be filled with a radioactive liquid containing Iodine-125, into the tumor area. The catheter and radioactive liquid make up the GliaSite Radiation Therapy System, developed by Proxima Therapeutics Inc. For the next 5-7 days, the catheter delivers radiation to the tissue surrounding the cavity. This is important because 80% of tumors reappear close or at the site of the original tumor location. Doctors then remove the catheter and put chemotherapy wafers into the cavity. The Gliadel wafers are produced by Guilford Pharmaceuticals. The wafers are absorbed in about three weeks, and the patient then begins oral chemotherapy just four to six weeks after surgery. The new treatment takes about half as long as traditional treatments. It also may reduce side effects associated with radiation and chemotherapy because the treatment is administered sequentially and is primarily directed to the original tumor site ­ an important feature of the new treatment. Traditional treatments for malignant brain tumors typically require surgery followed by a six to seven week course of radiation before a patient begins chemotherapy. Traditional brain tumor treatments can take up to four months and, with traditional treatment, patients have few remaining options if tumors reappear. However, the new treatment allows patients to receive traditional external radiation therapy if their tumors return. Study participation will be limited to adult patients undergoing treatment for localized, malignant brain tumors. (Patients with tumors spread throughout the brain will be excluded from the study.) The hope is that this new treatment will keep tumors away longer, treat people faster and more quickly return them to their normal lifestyles. Patients can be referred to the University of North Carolina Brain Tumor Center at (919) 966-1374 for consultation with our brain tumor specialists, Drs. Matthew Ewend, David Morris or Lav Goyal.

Treatment Schema: Newly diagnosed patients with presumed diagnosis of malignant glioma undergo surgery for maximal resection. Frozen section diagnosis of malignant glioma is confirmed. GliaSite® device placed at the time of surgery. After patient recovers from surgery, radiation therapy (60 Gy) is delivered via the GliaSite® Radiotherapy System (RTS) during a 5-7 day period. Patients return to operating room for removal of the GliaSite® RTS approximately 0-2 days after completion of the radiation therapy. During this surgery, Gliadel® wafers (BCNU-loaded chemotherapy wafers) are placed. If there is residual disease remaining at the time of surgery, maximal safe tumor resection is attempted. Adjuvant Temozolomide (200 mg/m2, days 1-5 of 28 day cycle X 6 cycles) is started 2 weeks after surgery. Patient Eligibility: Patients must have a unifocal, unilateral, and supratentorial tumor mass seen on MRI and/or CT that is suspicious for a malignant glioma. Patient must be a candidate for surgical resection of the tumor mass and be at least 18 years of age. Patients must give informed consent and understand the nature of this study and its potential risks and benefits. The tumor must be histopathologically confirmed malignant glioma by final pathology. Karnofsky performance status greater than or equal to 60. No prior radiation therapy to head and neck or brain. No pregnant or lactating women. All patients with the potential for pregnancy should be counseled and requested to follow acceptable birth control methods to avoid conception. Patients referred within 21 days of initial biopsy/resection from an outside institution who have not received any adjuvant therapy may be eligible for the study if the neurosurgeon determines that further tumor debulking/removal is warranted and the patient fulfills the eligibility criteria which are above described.

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