“A Randomized Phase II Study of Subventricular Zone (SVZ) Irradiation Plus Temozolomide in Newly Diagnosed Glioblastoma Multiforme”
Primary Objective: Compare progression-free survival (PFS) in patients receiving subventricular zone irradiation for newly diagnosed GBM to patients receiving neural progenitor cell sparing radiation therapy. This research is being done to see if an investigational method of giving radiation to adults with glioblastoma multiforme (GBM) can improve the local control and increase the time it may take for your brain cancer from coming back. You may be eligible to join this research study because your doctor recommends that you get radiation therapy and temozolomide to treat your GBM. For usual treatment of GBM, intensity modulation radiation therapy (IMRT) is used. As part of that procedure, certain parts of the brain are given less radiation to protect them such as the nerves that allow vision. For this research study, a part of the brain that contains cells that may contribute to glioblastoma recurrence will be given a higher dose of radiation than it typically receives. This part of the brain contains neural progenitor cells (NPC) which may be important in the brainâ??s response to injury but may also be involved in GBM recurrence. Some scientists think that giving less radiation to the NPC will allow for better repair of the radiation injury while other scientists think giving less radiation to NPC may allow GBM to recur earlier. This is a randomized study where three out of every four participants will receive an increased dose to the subventricular zone which contains NPC. One out of every four participants will receive standard radiation therapy, where the radiation dose to the NPC regions is reduced as much as possible while giving the full radiation dose to the tumor and other areas believed to be a risk.
â?¢ Newly diagnosed, histologically confirmed glioblastoma multiforme. â?¢ Radiation and medical oncologist recommends adjuvant radiation plus temozolomide. â?¢ Must begin therapy within 12 weeks of biopsy or surgery. â?¢ No prior brain radiation. â?¢ Age â?¥ 18 years. â?¢ KPS greater than 60%. â?¢ Signed informed consent.
Before you begin the study, you will need to have the following exams, tests or procedures to find out if you can be in the study. These exams, tests or procedures are part of regular cancer care and may be done even if you do not join the study. â?¢ A physical examination and your doctor will ask you about your medical history â?¢ You will be weighed and asked about your ability to carry out your daily activities â?¢ You will be asked what medicines you are taking â?¢ A MRI (Magnetic Resonance Imaging) of your brain. An MRI is imaging using strong magnetic field to look at one part of your body â?¢ At some point during your MRI exam the MRI staff will interrupt the scanning procedure in order to give a contrast agent. The agent is given through a needle placed (an IV) in your arm. The IV will be placed using standard hospital techniques. â?¢ A blood draw (about 5 tablespoons of blood will be taken from your vein) â?¢ A CT scan â?¢ You will have memory testing that will take about 1 hour and will involve remembering numbers, connecting symbols and letters, and answering questions about time and place â?¢ You will be asked about symptoms that you are having because of your cancer â?¢ Women able to have children will have to have a negative pregnancy test During the study: If the exams, tests and procedures show that you can be in the study, and you choose to take part, then you will need the following tests and procedures. â?¢ You will be asked about your ability to carry out your daily activities â?¢ Radiation (6 weeks of radiation treatments). The length of radiation is the same as if you were not in this research study: â?¢ You will be randomly assigned (by chance) in the following ways: o For three out of four patients, your brain radiation will be altered from standard radiation to give more radiation to an area of the brain called the subventricular zone as described above in Section 2. o One out of four patients will receive standard radiation therapy where radiation dose to the subventricular zone is limited as much as possible while delivering the full radiation dose to the tumor. â?¢ Chemotherapy (6 weeks during radiation, followed by 6 monthly treatments). The length of chemotherapy is the same as if you were not in this research study. â?¢ A blood draw (about 5 tablespoons of blood will be taken out of your vein once a week while you are receiving chemotherapy) â?¢ You will be asked about symptoms that you are having because of your cancer and/or your treatment You will need these tests and procedures in follow-up visits: â?¢ A physical exam â?¢ You will be asked about your ability to carry your daily activities â?¢ You will have memory testing that will take about 1 hour and will involve remembering numbers, connecting symbols and letters, and answering questions about time and place â?¢ You will be asked about symptoms that you are having because of your cancer and/or your treatment The radiation treatments will be daily, and every effort will be made to have them Monday through Friday for about 6 weeks. You will take the chemotherapy for about 8 months. In order to know how you are doing, we plan to have appointments with you for the rest of your life.
09/22/2014 04:03 AM