Temozolomide is a drug that is designed to work by stopping cancer cells from making new DNA. If they cannot make DNA, they can't split into 2 new cancer cells.
Pegylated Interferon alpha-2b is a protein made by the human immune system that helps to fight viral infections and regulate cell function.
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to one of two treatment groups (Arm A or Arm B). You have an equal chance of being assigned to either group and getting the treatment assigned to that group. You will not know which group you are assigned to.
Arm A: Participants in this group will take temozolomide once a day for 7 days in a row. This will be followed by 7 days without any treatment. This will be repeated 3 more times(for a total of 8 weeks - 1 cycle) before you have routine surgery.
Arm B: Participants in this group will take temozolomide on the same schedule as those in Arm A. However, participants in this group will also receive pegylated interferon alpha-2b as an injection under the skin once a week for a total of 8 weeks before they have routine surgery. Tylenol will be given to participants in this group before their pegylated interferon alpha-2b injection. After the first injection, they will also need to stay in the clinic for 2 hours of observation.
Your body weight will be used when calculating the dosage of Temozolomide.
You will have blood (about 1 tablespoon each time) drawn at 2 times, to check your response to treatment. The first sample will be drawn before you start treatment. The second sample will be drawn around Day 57 of treatment.
On Days 15, 29, 43, and 57 of treatment, you will be asked about any illness you have experienced and any medications you may be taking. You will have a physical exam, including measurement of vital signs. You will have tumor measurements and a performance status evaluation. You will also have about 1 tablespoon of blood drawn for routine tests at each visit . Any side effects you may have experienced will also be recorded.
All participants will receive 1 cycle (8 weeks) of treatment followed by surgery to remove the tumor. The size of the tumor will be closely monitored during study treatment. If the tumor increases in size by 50% (half) or greater, study treatment will be stopped and you will immediately have surgery. If you have to stop treatment due to side effects from the drug(s), you may be able to start up again once the side effect has gone away or decreased in severity enough. However, the time you are off therapy will count towards the total 8 weeks that you can receive treatment. If recovery from the side effect requires a total of 8 weeks or more from the start of treatment, you will be removed from the study and receive surgery. Tumor and blood samples will be collected during surgery to check how the disease is responding to treatment.
Your routine surgery will be scheduled to take place up to 90 days following completion of your treatment and as soon as your blood counts have recovered to the normal level.
After surgery, if you are experiencing side effects from the study drugs, but show stable disease or you are responding to treatment, you will be able to receive 3 additional cycles of therapy (24 weeks). You will have a physical exam, including measurement of vital signs and routine blood tests (about 1 tablespoon) every 4 weeks. You will then be followed every 3 months with routine blood tests (about 1 tablespoon each time) for the first 3 years, and every 6 months up to 8 years. After that, follow-up will be at the discretion of your primary physician. CT scans of your chest, abdomen, and pelvis will be performed after each cycle of therapy for the 3 additional cycles, then every 6 months up to 5 years and then, at the discretion of your primary physician.
This is an investigational study. Temozolomide alone and given with pegylated interferon alpha-2b is authorized for use in research only. Neither of these drugs is currently approved by the FDA for this treatment. About 124 patients will be enrolled on this study. All will be enrolled at M. D. Anderson.
