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A Phase II Trial of Temozolomide and Radiotherapy Followed by
Temozolomide and Maintenance Cis-retinoic Acid for Patients with Newly Diagnosed Gliomas
[Protocol 05-079]
- Full Title :
- A RANDOMIZED PHASE II TRIAL OF CONCURRENT TEMOZOLOMIDE AND RADIOTHERAPY FOLLOWED BY DOSE DENSE VERSUS METRONOMIC TEMOZOLOMIDE AND MAINTENANCE CIS-RETINOIC ACID FOR PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA AND OTHER MALIGNANT GLIOMAS
- Purpose :
Temozolomide is a an anticancer drug used to treat malignant brain tumors in adults. A recent study showed that patients with newly diagnosed glioblastoma (the most aggressive form of brain cancer) lived longer when treated with both temozolomide and radiation therapy followed by 6 months of temozolomide than patients treated with radiation therapy alone.
In this study, all patients will receive standard temozolomide and brain irradiation. Patients will then be randomly assigned to one of two groups: One group will receive continuous low-dose temozolomide daily. The other group will receive a more intense dose schedule of temozolomide. After 6 months of chemotherapy, if a patient's brain tumor has not shown any sign of growth, he/she will begin receiving cis-retinoic acid -- a drug that has been shown to possibly prevent or delay tumor recurrence. Investigators will see which treatment regimen is more effective.
Finally patients' tumor tissue (the sample used to diagnosis the cancer) will be checked for an enzyme called MGMT. MGMT may predict a good response to treatment. A special MRI picture will also be obtained with the first MRI performed after radiation, to help visualize blood flow in the area of abnormality. Doctors will see if this image can be used to predict when a tumor may grow again.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must be newly diagnosed with glioma that has not been treated with chemotherapy, radiation therapy, or biologic therapy.
- Patients must be between the ages of 18 and 70 (inclusive).
For more information and to see if you are eligible for this study, please contact Dr. Andrew Lassman at 212-639-6037.
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