Glioblastoma Clinical Trial
Official title:
Phase II Portion of Multi Phase Study of Sorafenib With Radiation and Temozolomide in Newly Diagnosed Glioblastoma or Gliosarcoma
The goal of this clinical research study is to find the highest tolerable dose of sorafenib that can be given in combination with temozolomide. The safety of this combination will also be studied.
The Study Drugs:
Sorafenib is designed to stop the cell growth and to block the formation of new blood
vessels (the tubes that carry blood around the body), which are involved in the growth and
development of tumors.
Temozolomide is designed to kill cancer cells by damaging DNA (the genetic material of
cells). The damaged DNA may cause tumor cell death.
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to 1 of 4
groups based on when you joined this study. You will remain in the same group for the entire
study. In this study, the dose of the study drugs is different from group to group, and the
doses are also different during and after radiation. During radiation, the study drugs and
doses are as follows:
- If you are in Group 1, you will take temozolomide.
- If you are in Groups 2 or 3, you will take temozolomide and the lower dose of
sorafenib.
- If you are in Group 4, you will take temozolomide and the higher dose of sorafenib.
- During radiation, all the groups will take the same dose of temozolomide.
After Radiation:
- If you are in Groups 1 or 2, you will take the higher dose of temozolomide on a shorter
cycle and the higher dose of sorafenib.
- If you are in Group 3, you will take the lower dose of temozolomide on a longer cycle
and the lower dose of sorafenib.
- If you are in Group 4, you will take the lower dose of temozolomide on a longer cycle
and the higher dose of sorafenib.
The amount of study drugs you receive may change if you experience side effects. If at any
time you experience any intolerable side effects, tell the study doctor right away.
Study Drug Administration:
During Radiation:
As a part of standard of care, you will receive radiation therapy Monday-Friday for a total
of 30 radiation treatments (about 6 weeks).
Every day while you are receiving radiation, you will take the temozolomide by mouth once a
day (up to a maximum of 7 weeks). On Monday-Friday, you will take temozolomide 1 hour before
radiation therapy. On Saturday and Sunday, you will take temozolomide in the morning.
You should swallow temozolomide whole, one right after the other, without chewing them. If
you vomit while taking temozolomide, you cannot take more capsules before the next scheduled
dose. They should be taken on an empty stomach (at least 1 hour before and 2 hours after
eating) with 1 cup (about 8 oz.) of water.
Every day while you are receiving radiation, you will take sorafenib by mouth 2 times a day
(in the morning and evening) (up to a maximum of 7 weeks). You should take sorafenib without
food (1 hour before or 2 hours after eating), with at least 1 cup (8 oz.) of water. If you
are in Group 1, you will not take sorafenib.
After Radiation:
You will not take the study drug(s) for about 4 weeks after the radiation therapy ends.
After 4 weeks:
- If you are in Group 1 or 2, on Days 1-5 of every 28-day study cycle, you will take
temozolomide by mouth once a day.
- If you are in Group 3 or 4, on Days 1-21 of every cycle, you will take temozolomide by
mouth once a day.
Every day of each cycle, all groups will take sorafenib by mouth 2 times (in the morning and
evening).
Study Visits:
During Radiation:
Once a week while you are receiving radiation therapy, you will be asked about any drugs you
may be taking and if you have experienced any side effects. Your blood pressure will be
measured. Blood (about 3-4 teaspoons) will be drawn for routine tests.
After Radiation:
About 3-4 weeks after the end of radiation therapy, you will have a MRI scan to check the
status of the disease.
On Day 1 of every cycle, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your vital signs.
- You will have a neurological exam.
- You will have a performance status evaluation.
- You will be asked about any drugs you may be taking and if you have experienced any
side effects.
- Blood (about 3-4 teaspoons) will be drawn for routine tests.
On Days 7, 14, and 21 of Cycle 1 and on Days 7 and 14 (or 21) of Cycles 2 and beyond, blood
(about 3-4 teaspoons) will be drawn for routine tests.
On Day 1 of every other cycle (Cycles 3, 5, 7, and so on), you will have a MRI scan to check
the status of the disease.
Every week of Cycle 1, your blood pressure will be measured.
Length of Study:
You will be on study for about 15 months total. You will be taken off study early if the
disease gets worse or you experience intolerable side effects.
End-of-Study Visit:
After you go off study, you will have an end-of-study visit. At this visit, the following
tests and procedures will be performed:
- You will have a physical exam, including measurement of your weight and vital signs.
- You will be have a performance status evaluation.
- You will be asked about any drugs you may be taking and if you have experienced any
side effects.
- You will have a neurological exam.
- You will have a MRI scan to check the status of the disease.
- Blood (about 3 teaspoons) will be drawn for routine tests.
This is an investigational study. Temozolomide is FDA approved and commercially available
for the treatment of brain tumors. Sorafenib is FDA approved and commercially available for
the treatment of kidney cancer, but it is experimental for use in brain tumors. In addition,
the combination of temozolomide and Sorafenib is experimental for use in brain tumors. At
this time, the combination is only being used in research.
Up to 51 participants will take part in this study. All will be enrolled at M. D. Anderson.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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