Combination of 6-Thioguanine, Capecitabine, Celecoxib and Temozolomide or CCNU for Recurrent Anaplastic Glioma and Glioblastoma Multiforme
Capecitabine is a drug that damages the DNA (deoxyribonucleic acid) of tumor cells and
blocks the function of DNA and RNA (ribonucleic acid) of tumor cells. These actions help to
kill the tumor cells.
Celecoxib is a drug that may help to prevent the development of some types of cancer by
blocking a type of enzyme (COX-2) that is found in tumor cells.
Temozolomide and CCNU are the current standard treatment for malignant brain tumors. Both
drugs work by damaging the DNA (deoxyribonucleic acid) of tumor cells to kill these tumor
cells.
6-Thioguanine is a drug that helps to increase the effects of Temozolomide and CCNU on tumor
cells.
Depending on the previous treatment you have received, you will be treated according to Arms
1, 2, or 3.
If you have not received temozolomide before, you will be treated on Arm 1. If you have
received temozolomide before but only during radiation therapy and not as chemotherapy
afterwards and the treatment was over 6 months ago, you will be treated with temozolomide
according to Arm 1.
If you have not received lomustine or carmustine, you will be treated on Arm 2. If you have
received Gliadel wafers at surgery greater than 6 months ago and have not been treated with
lomustine or carmustine, you will be treated with CCNU according to Arm 2.
Arm 3 will include glioblastoma multiforme patients who may be treated with either
temozolomide or lomustine according to the above guidelines and regimens described in Arms 1
and 2.
Arm 1:
Treatment will begin with 6-thioguanine taken by mouth 4 times a day (every 6 hours) for 3
days in a row (Days 1-3). This will be followed by temozolomide taken by mouth at bedtime
for 5 days in a row (Days 4-8). After a rest period of 6 days, capecitabine and celecoxib
will be taken by mouth twice a day (12 hours apart) for 14 days (Days 14-27). Each cycle of
treatment on arm 1 will be 28 days.
Arm 2:
Treatment will begin with 6-thioguanine taken by mouth 4 times a day (every 6 hours) for 3
days in a row (Days 1-3). This will be followed by lomustine taken by mouth at bedtime for 1
day (Day 4). After a rest period of 1 week, capecitabine and celecoxib will be taken by
mouth twice a day (12 hours apart) for 14 days (Days 11-24). Each cycle of treatment on arm
2 will take 42 days.
Blood tests (less than 2 teaspoons) will be repeated every 2 weeks and before each new cycle
of treatment (a total of about 2 tablespoons). The neurological exam, anticonvulsant level
blood tests and the stool test for blood, will be repeated before every cycle on Arms 2 and
3 (CCNU) and before every 2 cycles on Arms 1 and 3 (temozolomide). Kidney function will be
evaluated from the blood tests before every other course. Patients taking anticoagulants
(coumadin, warfarin) will have procedures to test the clotting ability of the blood before
each cycle or more frequently if the doctor feels it is necessary.
Arm 3:
Glioblastoma Multiforme patients will be treated on Arm 3 which will include the drug
regimen from either Arm 1 or Arm 2.
Treatment on all arms will continue for 1 year as long as the tumor does not grow and any
side effects are tolerable. Treatment may continue beyond one year if your doctor feels it
is needed. During the study, you may not receive any other investigational drug or have any
other treatment for the cancer, including surgery.
This is an investigational study. All drugs used in this study are FDA approved and are
commercially available. A total of 140 patients will take part in this study. All patients
will be enrolled at M. D. Anderson.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
12 Month-progression-free Survival for Participants With Anaplastic Tumors
Progression-free Survival (PFS) at 12 months measured as percentage of participants that are alive and progression-free at 12 months (anaplastic tumors). A combination of neurological examination and MRI brain scan used to define overall response or progression.
12 months
No
Charles Conrad, MD
Principal Investigator
UT MD Anderson Cancer Center
United States: Institutional Review Board
2003-0600
NCT00504660
September 2003
August 2010
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |