A Phase 2 interventional study of Capecitabine and Celecoxib (Celebrex) in Anaplastic Glioma of Brain, Glioblastoma Multiforme and Brain Cancer, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2012-01-11.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment
The goal of this clinical research study is to learn if the combination of 6-Thioguanine, Xeloda (capecitabine), and Celebrex (celecoxib) with Temodar (temozolomide) or Lomustine (CCNU) is effective in the treatment of recurrent or progressive anaplastic glioma or glioblastoma multiforme in patients who have failed previous treatments. The safety of these combination treatment will also be studied.
Objectives:
1.1 To determine the efficacy, as measured by 12 month progression-free survival, of TEMOZOLOMIDE or CCNU with 6-THIOGUANINE followed by CAPECITABINE and CELECOXIB in the treatment of patients with recurrent and/or progressive anaplastic gliomas or glioblastoma multiforme.
1.2 To determine the long-term toxicity of TEMOZOLOMIDE or CCNU with 6-THIOGUANINE followed by CAPECITABINE and CELECOXIB in recurrent anaplastic glioma or glioblastoma multiforme patients treated in this manner.
1.3 To determine the clinical relevance of genetic subtyping tumors as a predictor of response to this chemotherapy and long term survival
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.
1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.
This study's enrollment of 75 is above the median of 36 across 1,618 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Anaplastic Tumors - 6-TG 80 mg/m\^2 orally (PO) every 6 hours Day 1-3; Temozolomide 150 mg/m\^2 PO daily Days 4-8, after 6 day rest Capecitabine 825 mg/m\^2 and Celebrex 400 mg PO every 12 hours Day 14-27 for 28 day course.
Drug: Capecitabine · Drug: Celecoxib (Celebrex) · Drug: Temozolomide · Drug: 6-Thioguanine
Anaplastic Tumors - 6-TG 80 mg/m\^2 PO every 6 hours Day 1-3, Lomustine 100 mg/m\^2 PO on Day 4; Capecitabine 825 mg/m\^2 PO every 12 hours Days 11-24, and Celebrex 400 mg PO every 12 hours Days 11-24. Participants if previously received Temozolomide but not Lomustine (CCNU) will receive Lomustine; or if had Gliadel wafers and Temozolomide with radiotherapy (XRT) will receive Temozolomide.
Drug: Capecitabine · Drug: Celecoxib (Celebrex) · Drug: Lomustine · Drug: 6-Thioguanine
Glioblastoma Multiforme - 6-TG 80 mg/m\^2 PO every 6 Hours Day 1-3; Capecitabine 825 mg/m\^2 PO every 12 hours Days 14-27 and Celebrex 400 mg PO every 12 hours Day 11-24; Temozolomide 150 mg/m\^2 PO daily Days 4-8 OR CCNU (Lomustine) 100 mg/m2 orally Day 4 of each 42-day cycle. Participants receive Temozolomide if not had previous treatment and if had prior CCNU. Those previously treated with Temozolomide but not CCNU receive CCNU, and those that had Gliadel and Temozolomide with XRT receive Temozolomide.
Drug: Capecitabine · Drug: Celecoxib (Celebrex) · Drug: Temozolomide · Drug: Lomustine · Drug: 6-Thioguanine
Arms 1,3 = 825 mg/m\^2 By Mouth (PO) Every 12 Hours on Day 14-27; Arms 2,3 = 825 mg/m\^2 PO Every 12 Hours on Day 11-24.
Also known as: Xeloda
Arms 1,3 = 400 mg PO Every 12 Hours On Day 14-27; Arms 2,3 = 400 mg PO Every 12 Hours On Day 11-24.
Also known as: Celebrex
Arms 1,3 = 150 mg/m\^2 PO Daily On Day 4-8.
Also known as: Temodar, TMZ
Arms 2,3 = 100 mg/m\^2 PO on Day 4.
Also known as: CCNU
Arms 1,2,3 = 80 mg/m\^2 PO Every 6 Hours on Day 1-3.
Also known as: Thioguanine, 6-TG
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.
Time frame: 12 months
6 Month Progression-free Survival for Participants With Glioblastoma
Progression-free Survival (PFS) at 6 months measured as percentage of participants that are alive and progression-free at 6 months (glioblastoma multiforme). A combination of neurological examination and MRI brain scan used to define overall response or progression.
Time frame: 6 months
Recruitment period: September 23, 2003 to June 15, 2009. All patients recruited at UT MD Anderson Cancer Center.
| Milestone | Anaplastic Tumors | Glioblastoma Multiforme |
|---|---|---|
| Started | 31 | 43 |
| Completed | 31 | 43 |
| Not completed | 0 | 0 |
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.
| percentage of participants | Participants With Recurrent Anaplastic Glioma |
|---|---|
| 12 Month-progression-free Survival for Participants With Anaplastic Tumors | 44 ± 5 |
Progression-free Survival (PFS) at 6 months measured as percentage of participants that are alive and progression-free at 6 months (glioblastoma multiforme). A combination of neurological examination and MRI brain scan used to define overall response or progression.
| percentage of participants | Participants With Glioblastoma Multiforme |
|---|---|
| 6 Month Progression-free Survival for Participants With Glioblastoma | 14 |
Collected over 6 years and 3 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Anaplastic Tumors | — | 8/31 (25.8%) | 31/31 (100%) |
| Glioblastoma Multiforme | — | 16/43 (37.2%) | 43/43 (100%) |
| Event | Anaplastic Tumors | Glioblastoma Multiforme |
|---|---|---|
| Thrombosis/EmbolismVascular disorders | 1/31 | 5/43 |
| VomitingGastrointestinal disorders | 1/31 | 3/43 |
| Muscle WeaknessMusculoskeletal and connective tissue disorders | 1/31 | 2/43 |
| DiarrheaGastrointestinal disorders | 1/31 | 2/43 |
| NauseaGastrointestinal disorders | 1/31 | 2/43 |
| SeizureNervous system disorders | 1/31 | 1/43 |
| HemorrhageGeneral disorders | 1/31 | 1/43 |
| PneumonitisInfections and infestations | 1/31 | 0/43 |
| Pain-BackMusculoskeletal and connective tissue disorders | 1/31 | 1/43 |
| ThrombocytopeniaBlood and lymphatic system disorders | 1/31 | 0/43 |
| Event | Anaplastic Tumors | Glioblastoma Multiforme |
|---|---|---|
| HYPERGLYCEMIAMetabolism and nutrition disorders | 14/31 | 43/43 |
| FATIGUEGeneral disorders | 24/31 | 30/43 |
| HEMOGLOBINBlood and lymphatic system disorders | 24/31 | 33/43 |
| LEUKOCYTESBlood and lymphatic system disorders | 21/31 | 33/43 |
| LYMPHOPENIABlood and lymphatic system disorders | 21/31 | 33/43 |
| PLATELETSBlood and lymphatic system disorders | 23/31 | 31/43 |
| NEUTROPHILS (ANC/AGC)Blood and lymphatic system disorders | 15/31 | 28/43 |
| MUSCLE WEAKNESSMusculoskeletal and connective tissue disorders | 10/31 | 26/43 |
| NAUSEAGastrointestinal disorders | 16/31 | 16/43 |
| CONSTIPATIONGastrointestinal disorders | 15/31 | 15/43 |
| Age, Categorical(Participants) | Anaplastic Tumors | Glioblastoma Multiforme | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 29 | 34 | 63 |
| >=65 years | 2 | 9 | 11 |
| Sex: Female, Male(Participants) | Anaplastic Tumors | Glioblastoma Multiforme | Total |
|---|---|---|---|
| Female | 14 | 15 | 29 |
| Male | 17 | 28 | 45 |
| Region of Enrollment(participants) | Anaplastic Tumors | Glioblastoma Multiforme | Total |
|---|---|---|---|
| United States | 31 | 43 | 74 |
This study is completed, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
M.D. Anderson Cancer Center