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Celecoxib in Patients With Newly Diagnosed GBM Who Are Receiving Anticonvulsant Drugs and Undergoing RT

Information source: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Brain and Central Nervous System Tumors

Intervention: radiation therapy (Radiation); Celecoxib (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Sidney Kimmel Comprehensive Cancer Center

Official(s) and/or principal investigator(s):
Stuart A. Grossman, MD, Study Chair, Affiliation: Sidney Kimmel Comprehensive Cancer Center

Summary

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.

Clinical Details

Official title: A Pharmacokinetic Study of the Interaction Between Celecoxib and Anticonvulsant Drugs in Patients With Newly Diagnosed Glioblastoma Multiforme Undergoing Radiation Therapy

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Effects of Hepatic Enzyme Inducing Drugs Such as Anticonvulsants, on the PK of Celecoxib

Secondary outcome: Overall Survival

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida 33612-9497, United States

Winship Cancer Institute of Emory University, 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

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Related publications:

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.

Starting date: October 2003
Last updated: March 17, 2015

Page last updated: August 23, 2015

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