Celecoxib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme Who Are Receiving Anticonvulsant Drugs and Undergoing Radiation Therapy
This study has been completed.
Sponsor:
Sidney Kimmel Comprehensive Cancer Center
Collaborator:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00068770
First received: September 10, 2003
Last updated: May 1, 2012
Last verified: May 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: celecoxib Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pharmacokinetic Study of the Interaction Between Celecoxib and Anticonvulsant Drugs in Patients With Newly Diagnosed Glioblastoma Multiforme Undergoing Radiation Therapy |
Resource links provided by NLM:
Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:
| Enrollment: | 35 |
| Study Start Date: | October 2003 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: p450
on p450 inhibitor
|
Drug: celecoxib Radiation: radiation therapy |
|
Active Comparator: nonp450
not on p450 inhibitor
|
Drug: celecoxib Radiation: radiation therapy |
Detailed Description:
OBJECTIVES:
Primary
- Determine the effects of hepatic enzyme-inducing drugs, such as anticonvulsants, on the pharmacokinetics of celecoxib in patients with newly diagnosed glioblastoma multiforme undergoing radiotherapy.
- Determine the effects of steroids on the pharmacokinetics of celecoxib in these patients.
Secondary
- Determine the safety of celecoxib in these patients.
- Determine the duration of survival of patients treated with this regimen.
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:
- Phenytoin
- Carbamazepine
- Phenobarbital
- Primidone
- Oxcarbazepine
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:
- Gabapentin
- Lamotrigine
- Valproic acid
- Levetiracetam
- Tiagabine
- Topiramate
- Zonisamide
- Felbamate
- 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00068770
Locations
| United States, Florida | |
| H. Lee Moffitt Cancer Center and Research Institute | |
| Tampa, Florida, United States, 33612-9497 | |
| United States, Georgia | |
| Winship Cancer Institute of Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231-2410 | |
| United States, Massachusetts | |
| Massachusetts General Hospital Cancer Center | |
| Boston, Massachusetts, United States, 02114-2617 | |
| United States, North Carolina | |
| Comprehensive Cancer Center at Wake Forest University | |
| Winston-Salem, North Carolina, United States, 27157-1030 | |
| United States, Ohio | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Pennsylvania | |
| Abramson Cancer Center of the University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104-4283 | |
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
| Study Chair: | Stuart A. Grossman, MD | Sidney Kimmel Comprehensive Cancer Center |
More Information
Additional Information:
Publications:
| Responsible Party: | Sidney Kimmel Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00068770 History of Changes |
| Other Study ID Numbers: | NABTT-2100 CDR0000328117, U01CA062475, NABTT-2100, JHOC-NABTT-2100 |
| Study First Received: | September 10, 2003 |
| Last Updated: | May 1, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
|
adult glioblastoma adult giant cell glioblastoma adult gliosarcoma |
Additional relevant MeSH terms:
|
Glioblastoma Nervous System Neoplasms Central Nervous System Neoplasms Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases Anticonvulsants |
Celecoxib Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on June 17, 2013