A Phase I-II Trial Everolimus and Sorafenib in Patients With Recurrent High-Grade Gliomas
Study Drugs:
Sorafenib is designed to stop 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.
Everolimus is designed to block a special protein in tumor cells and block the formation of
new blood vessels, which is important in tumor growth.
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a study
Phase based on when you join this study.
If you are enrolled in Phase 1, you will be assigned to 1 of 6 dose levels of the
combination of everolimus and sorafenib based on when you join this study. You will remain
on the same dose level for the entire study. Up to 3 participants will be enrolled at each
dose level. The first 3 participants in each group will receive the lowest dose level.
Each set of 3 new participants will receive a higher dose than the one before it, if no
intolerable side effects were seen. This will continue until the highest tolerable dose of
study drugs given in combination is found.
If you are enrolled in Phase 2, you will receive the combination of everolimus and sorafenib
at the highest dose and on the same schedule that was tolerated in Phase 1. Up to 82
participants will be enrolled in the Phase 2 part of the study.
Study Drug Administration:
Each cycle is 28 days.
You will take everolimus by mouth 1 time a day every day while you are on study.
You should take everolimus whole without chewing them. You should take everolimus without
food (1 hour before or 2 hours after eating), with at least 1 cup (8 oz.) of water in the
morning, at the same time each day. You must not drink grapefruit juice or eat grapefruit
products while taking everolimus.
You will either take sorafenib by mouth 2 times every day or on Days 1-7 and Days 15-21 of
every cycle.
You should take sorafenib without food (1 hour before or 2 hours after eating), with at
least 1 cup (8 oz.) of water.
You may take the study drugs at the same time.
If you vomit while taking the study drugs, you should not take more capsules before the next
scheduled dose.
Study Visits:
Every 2 weeks:
- Blood (about 1-2 teaspoons) will be drawn for routine tests.
- Urine will be collected to check your kidney function.
Every 4 weeks:
- You will have a neurologic exam.
- Your performance status will be recorded.
- Blood (about 2 teaspoons) will be drawn to check your pancreatic function, and test
your blood fat level.
- You will be asked about any drugs you may be taking and if you have had any side
effects. (For the first cycle, this is every week if you are in Phase 1.)
- Your blood pressure will be recorded (For the first cycle, this is every week).
Every 4 weeks for the first 2 cycles or the first 4 cycles (if you received bevacizumab
previously), then every 8 weeks:
- You will have a brain MRI scan or CT scans to check the status of the disease.
- You will complete the quality-of-life questionnaire.
At any time during the study, extra tests may be performed if the doctor thinks they are
needed for your safety. The study doctor will tell you more about any extra tests.
Length of Study:
You will remain on study treatment for as long as you are benefitting. You will be taken off
study early if the disease gets worse, if intolerable side effects occur, or if you are
unable to follow study directions.
Long-Term Follow-Up Visit:
After you stopped taking the study drugs, 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. Everolimus is FDA approved and commercially available for
the treatment of kidney cancer and certain types of brain tumors. Sorafenib is FDA approved
and commercially available for the treatment of kidney cancer. The combination of
everolimus and sorafenib to treat brain tumors is investigational. At this time, this
combination is only being used in research.
Up to 118 participants will take part in this multicenter study. Up to 30 will be enrolled
at MD Anderson.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Six-month Progression Free Survival (PFS)
PFS is the number of participants progression free (with no disease progression) six months from registration.
Six months from participant registration
Yes
Marta Penas-Prado, MD
Principal Investigator
UT MD Anderson Cancer Center
United States: Food and Drug Administration
BTTC09-01
NCT01434602
October 2012
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |