Clinical trial · Interventional
Celecoxib in Patients With Newly Diagnosed GBM Who Are Receiving Anticonvulsant Drugs and Undergoing RT
A Pharmacokinetic Study of the Interaction Between Celecoxib and Anticonvulsant Drugs in Patients With Newly Diagnosed Glioblastoma Multiforme Undergoing Radiation Therapy
NCT00068770CI-TRIAL-00017161terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): EORTC trail showed TMZ \& RT conferred significant survivial in this population
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Celecoxib | Drug | Celecoxib | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- p450 ( +EIASD)
- description
- 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
- interventionNames
- Radiation: radiation therapy
- Drug: Celecoxib
- type
- ACTIVE_COMPARATOR
- label
- nonp450 (-EIASD)
- description
- 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
- interventionNames
- Radiation: radiation therapy
- Drug: Celecoxib
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed glioblastoma multiforme * Supratentorial * Grade IV astrocytoma PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 60-100% Life expectancy * Not specified Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 9.0 g/dL Hepatic * Bilirubin no greater than 1.5 mg/dL * Transaminases no greater than 4 times upper limit of normal Renal * Creatinine no greater than 1.7 mg/dL * Creatinine clearance at least 60 mL/min * No prior renal toxicity with nonsteroidal anti-inflammatory drugs Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Mini mental score at least 15 * No history of peptic disease * No serious concurrent infection * No other medical illness that would preclude study participation * No other malignancy within the past 5 years except curatively treated carcinoma in situ or basal cell skin cancer * No allergy to sulfonamides * Able to tolerate cyclo-oxygenase-2 (COX-2) inhibitors PRIOR CONCURRENT THERAPY: Biologic therapy * No prior immunotherapy or biologic agents for the malignancy, including any of the following: * Immunotoxins * Immunoconjugates * Antisense agents * Peptide receptor antagonists * Interferons * Interleukins * Tumor-infiltrating lymphocytes * Lymphokine-activated killer cells * Gene therapy * No concurrent prophylactic growth factors (e.g., filgrastim \[G-CSF\] or sargramostim \[GM-CSF\]) Chemotherapy * No prior chemotherapy for the malignancy Endocrine therapy * No prior hormonal therapy for the malignancy * Prior glucocorticoid therapy allowed * Concurrent corticosteroids allowed provided there has been no dose increase within the past 5 days Radiotherapy * No prior radiotherapy for the malignancy Surgery * Recovered from prior surgery Other * At least 1 week since prior fluconazole * More than 10 days since prior anticonvulsant drugs that induce hepatic metabolic enzymes (Group A) * No other prior therapy for the malignancy * No concurrent enrollment in another therapeutic clinical trial * No concurrent fluconazole
References
Publications (1)
- BACKGROUNDGrossman 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. PMID 18287342