Randomized Phase II Trial of Standard Dose Bevacizumab Versus Low Dose Bevacizumab Plus Lomustine (CCNU) In Adults With Recurrent Glioblastoma Multiforme
The Study Drugs:
Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the
growth of blood vessels.
Lomustine is designed to damage the DNA (genetic material of cells) of tumor cells, which
may cause the tumor cells to die.
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned
(as in the flip of a coin) to 1 of 2 groups. You will have an equal chance of being in
either group.
- If you are in Group 1, you will receive a higher dose of bevacizumab.
- If you are in Group 2, you will receive lomustine and a lower dose of bevacizumab
Study Drug Administration:
Each treatment cycle is 42 days.
If you are in Group 1:
-On Days 1, 15, and 29 of every cycle, you will receive bevacizumab by vein over 90 minutes.
If you are in Group 2:
- On Days 1 and 22 of every cycle, you will receive bevacizumab by vein over 90 minutes.
- On Day 3 of every cycle, you will take lomustine by mouth 1 time a day. You should take
lomustine at bedtime 1 hour before or 2 hours after your last meal of the day with 1
cup (about 8 ounces) of water.
Study Visits:
If you are in Group 1 or 2, every 6 weeks:
- You will be asked about any drugs you may be taking and if you have had any side
effects.
- You will have a physical exam, including measurement of your vital signs and weight.
- You will have a neurological exam.
- Your performance status will be recorded.
- You will have an MRI scan.
- If you are on anti-seizure drugs, blood (about 1 teaspoon) will be drawn to measure the
amount of anti-seizure drugs in your blood.
If you are in Group 1:
- During Weeks 1-6, blood (about 3 teaspoons) drawn for routine tests 1 time a week.
- After Week 6, blood (about 3 teaspoons) will be drawn for routine tests every 2 weeks.
- On Weeks 2, 4, and 6, and then every 6 weeks after that, urine will be collected to
check your kidney function.
If you are in Group 2:
- During Weeks 1-6, blood (about 3 teaspoons) drawn for routine tests 1 time a week.
- After Week 6, blood (about 3 teaspoons) will be drawn for routine tests every 3 weeks.
- On Weeks 3 and 6, and then every 6 weeks after that, urine will be collected to check
your kidney function.
Length of Study:
You may stay on study treatment for up to 2 years. You will be taken off study early if the
disease gets worse or you experience intolerable side effects.
End of Study Treatment Visit:
After you are off study treatment, you will have an end of study treatment visit. At this
visit, you may have some or all of the following tests and procedures performed:
- You will be asked about any drugs you may be taking and if you have had any side
effects.
- You will have physical exam, including measurement of your vital signs and weight.
- Blood (about 3 teaspoons) will be drawn for routine tests.
- You will have a neurological exam.
- Your performance status will be recorded.
Long-Term Follow-up:
After the end of study treatment visit, the study staff will call you every 3 months to
check how you are doing. Each phone call will take about 5 minutes.
This is an investigational study. Bevacizumab and lomustine are FDA approved drugs and
commercially available for the treatment of brain tumors. The use of these drugs in this
combination is investigational.
Up to 102 participants will take part in this study. All will be enrolled at MD Anderson.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients with PFS
Monitored at 3 time points: 1) after a total of 28 events occur (to monitor futility), after 55 events occur and 3) after at least 82 events occur.
Yes
John DeGroot, MD
Study Chair
UT MD Anderson Cancer Center
United States: Institutional Review Board
2009-0597
NCT01067469
February 2010
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |