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| ID | Type | Description | Link |
|---|---|---|---|
| U01CA062475 | U.S. NIH Grant/Contract | View source | |
| NABTT-2100 | |||
| JHOC-NABTT-2100 |
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EORTC trail showed TMZ & RT conferred significant survivial in this population
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. It is not yet known whether the effectiveness of celecoxib in treating glioblastoma multiforme is decreased in patients who are receiving anticonvulsant drugs and undergoing radiation therapy.
PURPOSE: Phase II trial to study the effectiveness of celecoxib in treating patients who are receiving anticonvulsant drugs and undergoing radiation therapy for newly diagnosed glioblastoma multiforme.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients are assigned to 1 of 2 groups based on anticonvulsant therapy.
Group A: Patients treated with any of the following anticonvulsant drugs that induce hepatic metabolic enzymes:
Group B: Patients treated with any of the following anticonvulsant drugs that cause modest or no induction of hepatic metabolic enzymes OR no anticonvulsant drug:
Induction therapy: Patients in both groups receive oral celecoxib twice* daily on weeks 1-11 and undergo radiotherapy 5 days a week on weeks 2-7.
Maintenance therapy: Patients receive oral celecoxib twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
NOTE: *Patients receive only 1 dose on the first day of celecoxib administration.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 44 patients (22 per group) will be accrued for this study within approximately 8 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| p450 ( +EIASD) | Active Comparator | on p450 inhibitor (Patients taking anttiseizure drugs that are known to induce the hepatic drug-metabolizing enzymes - including phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine) celecoxib and radiation therapy will be adminstered with this arm |
|
| nonp450 (-EIASD) | Active Comparator | not on p450 inhibitor (Patients either NOT taking anti-seizure drugs or ones that are known to not significantly influence the hepatic drug-metabolizing enzymes - including gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine,topiramate, zonisamide and filbamate. celecoxib and radiation therapy will be adminstered with this arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radiation therapy | Radiation | Radiation is standard treatment 6000cGy in 30 fractions. Patients will receive celecoxib 400 mg bid during RT treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effects of Hepatic Enzyme Inducing Drugs Such as Anticonvulsants, on the PK of Celecoxib | subjects will take one dose of celecoxib and will then have 6 hours of blood draws, day 2 subject will take 2 doses of celecoxib 8 hours apart with 2 additional blood samples, one hour apart. Subject, will continue to take 2 doses of celecoxib for 6 weeks, with a sample (PK) drawn every week prior to the first dose of the week. Comparison of Cmax of Celecoxib is reported | First dose of celecoxib through completion of radiation, 6 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | duration of survival when celecoxib is administered concurrently with radiation in pts with newly diagnosed glioblastoma multiforme | date pt started treatment to date pt last known alive |
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DISEASE CHARACTERISTICS:
Histologically confirmed glioblastoma multiforme
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
No prior immunotherapy or biologic agents for the malignancy, including any of the following:
No concurrent prophylactic growth factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF])
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Stuart A. Grossman, MD | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612-9497 | United States | ||
| Winship Cancer Institute of Emory University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18287342 | Background | Grossman SA, Olson J, Batchelor T, Peereboom D, Lesser G, Desideri S, Ye X, Hammour T, Supko JG; New Approaches to Brain Tumor Therapy CNS Consortium. Effect of phenytoin on celecoxib pharmacokinetics in patients with glioblastoma. Neuro Oncol. 2008 Apr;10(2):190-8. doi: 10.1215/15228517-2007-055. Epub 2008 Feb 20. |
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pts were assigned to an arm at the time of enrollment
pts were enrolled on this study from October 2003 to September 2004. Pts were enrolled in an outpatient clinical setting
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| ID | Title | Description |
|---|---|---|
| FG000 | nonp450 | not on p450 inhibitor celecoxib : radiation therapy : |
| FG001 | p450 | on p450 inhibitor celecoxib : radiation therapy : |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Celecoxib | Drug | Celecoxib will begin 1 week prior to RT at 400mg bid orally. One day 1 only 1 dose will be administered. Starting on day 2 and throughout treatment until progression, 2 doses will be administered at least 12 hours apart. Celecoxib will continue throughout the 6 week course of RT. |
|
|
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231-2410 | United States |
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114-2617 | United States |
| Comprehensive Cancer Center at Wake Forest University | Winston-Salem | North Carolina | 27157-1030 | United States |
| Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | 44195 | United States |
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104-4283 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | p450 ( +EIASD) | on p450 inhibitor (Patients taking anttiseizure drugs that are known to induce the hepatic drug-metabolizing enzymes - including phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine) |
| BG001 | nonp450 (-EIASD) | not on p450 inhibitor (Patients either NOT taking anti-seizure drugs or ones that are known to not significantly influence the hepatic drug-metabolizing enzymes - including gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine,topiramate, zonisamide and filbamate. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Karnofsky Perfomance Status (KPS) | 100 normal no complaints no disease 90 capable of normal activity few symptoms/disease 80 normal activity with some difficulty some symptoms or signs 70 caring for self not capable of normal activity or work 60 requiring some help can take care of most personal requirements 50 requires help often requires frequent medical care 40 disabled requires special care and help 30 severely disabled hospital admission indicated but no risk of death 20 very ill urgently requiring admission requires supportive measures or treatment 10 moribund rapidly progressive fatal disease processes 0 death | Mean | Standard Deviation | scores on a scale |
| ||||||||||||||
| Mini Mental State Exam Score | The mini-mental state examination (MMSE) is a 30-point questionnaire test used to screen for cognitive impairment. Commonly used to screen for dementia. It is also used to estimate the severity of cognitive impairment and to follow the course of cognitive changes in an individual over time. The MMSE test includes simple questions and problems in a number of areas: the time and place of the test, repeating lists of words, arithmetic such as the serial sevens, language use and comprehension, and basic motor skills. The Higher your score, the higher your function. | Mean | Standard Deviation | scores on a scale |
| ||||||||||||||
| Corticosteroid therapy | Patients on corticpsteroid therapy | Number | Participants |
| |||||||||||||||
| Prior Surgery | Whether pt had Craniotomy or Biopsy | Number | Participant |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Effects of Hepatic Enzyme Inducing Drugs Such as Anticonvulsants, on the PK of Celecoxib | subjects will take one dose of celecoxib and will then have 6 hours of blood draws, day 2 subject will take 2 doses of celecoxib 8 hours apart with 2 additional blood samples, one hour apart. Subject, will continue to take 2 doses of celecoxib for 6 weeks, with a sample (PK) drawn every week prior to the first dose of the week. Comparison of Cmax of Celecoxib is reported | pts who had PK data for the first dose of celecoxib. observations were excluded if sample was not collected within 12 +/- 2h after taking prior dose, was drawn after dosing on same day or determine to be outlier by dixon's test. PK data was available for 15 pts in the +EIASD group and 12 pts in the -EIASD group | Posted | Geometric Mean | Standard Deviation | (ng/ml) | First dose of celecoxib through completion of radiation, 6 weeks. |
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| Secondary | Overall Survival | duration of survival when celecoxib is administered concurrently with radiation in pts with newly diagnosed glioblastoma multiforme | latest survial data was obtained on May 30, 2006. 31/35 pts had died (89%) 21 in the +EIASD group and 10 in -EIASD group | Posted | Mean | 95% Confidence Interval | months | date pt started treatment to date pt last known alive |
|
|
until pts progressed off treatment - in this study approximately avg 117 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | P450 ARM | on p450 inhibitor (Patients taking anttiseizure drugs that are known to induce the hepatic drug-metabolizing enzymes - including phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine) | 0 | 22 | 22 | 22 | ||
| EG001 | Non P450 ARM | NOT on p450 inhibitor *non P450 ARM (Patients either NOT taking anti-seizure drugs or ones that are known to not significantly influence the hepatic drug-metabolizing enzymes - including gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine,topiramate, zonisamide and filbamate, Keppra. | 0 | 13 | 13 | 13 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abdominal pain or cramping | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| alopecia | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| anorexia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| ataxia | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Auditory/Hearing | Ear and labyrinth disorders | CTCAE (2.0) | Systematic Assessment | hearing loss |
|
| confusion | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
| |
| constipation | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| cushingoid appearance | Endocrine disorders | CTCAE (2.0) | Systematic Assessment |
| |
| dehydration | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dizziness/lightheadedness | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| dry skin | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| dyspepsia/heartburn | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| edema | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| fatigue | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| gastritis | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| dry mouth | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| headache | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
| |
| incontinence | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| infection without neutropenia | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
| |
| memory loss | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| depression | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
| |
| anxiety | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
| |
| muscle weakness (not due to neuropathy) | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| nausea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| neurology -cranial | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| neuropathy-motor | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| neuropathy - sensory | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Salivary Gland Changes | Endocrine disorders | CTCAE (2.0) | Systematic Assessment |
| |
| radiation dermatitis | Injury, poisoning and procedural complications | CTCAE (2.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| speech impairment | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| taste disturbance | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| tearing | Eye disorders | CTCAE (2.0) | Systematic Assessment |
| |
| tremor | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| urinary frequency/urgency | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| vision - blurred vision | Ear and labyrinth disorders | CTCAE (2.0) | Systematic Assessment |
| |
| vomiting | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| weight gain | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| alkaline phosphatase | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Hemoglobin / anemia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Platelets | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Asoartate aminotransferase (SGOT) | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| alanine aminotransferase (SGPT) | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| bilirubin | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| white blood count | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Photophobia | Nervous system disorders | CTCAE (2.0) | Systematic Assessment | Neurology-Other |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| hypernatremia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| hypoglycemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| hypokalemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| hypomagnesemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| hyponatremia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
Study ended early when results from another study became available documenting Temozolomide (TMZ) and radiation improved survival, we felt it was unethical to continue this study, our study did not include TMZ.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stuart A Grossman | Johns Hopkins University | 410-955-3657 | jfisher@jhmi.edu |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D005909 | Glioblastoma |
| D018316 | Gliosarcoma |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D000068579 | Celecoxib |
| D051545 | Cyclooxygenase 1 |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011451 | Prostaglandin-Endoperoxide Synthases |
| D009097 | Multienzyme Complexes |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
Not provided
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| Male |
|
| No |
|
| Biopsy |
|
| Participants |
|
|
|