A Phase III Trial of Lomustine-Temozolomide Combination Therapy Versus Standard Temozolomide in Patients with Methylated MGMT Promoter Glioblastoma
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The purpose of this study is to compare the usual radiation therapy and usual chemotherapy, temozolomide, to using the usual radiation therapy and usual chemotherapy plus the chemotherapy drug lomustine (Gleostine). Lomustine (Gleostine) is already approved by the FDA for use in brain tumors but it is usually used alone and is not the first-line choice for methylated MGMT tumors. Adding a second chemotherapy drug, lomustine (Gleostine), to usual chemotherapy and radiation therapy could extend your life or shrink or stabilize your cancer. But, it could also cause side effects, which the study team will hope to learn more about. This study will help the study doctors find out if this different approach is better than the usual approach. To decide if it is better, the study doctors will be looking to see if the study approach increases the life of patients by 6 months or more compared to the usual approach.
Are you Eligible? (Inclusion Criteria)
- Have you been diagnosed with glioblastoma (or gliosarcoma as a type of glioblastoma) that is methylated?
- Are you between the ages of 18 and 70?
- Would this be the first therapy you have received for your brain tumor?
- Are you able to make extra visits to the clinic for treatment and evaluation?
