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


Phase 2
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Principal Investigator

Stuart A. Grossman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

NABTT-2100 CDR0000328117

NCT ID:

NCT00068770

Start Date:

October 2003

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult glioblastoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Glioblastoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283
Massachusetts General Hospital Cancer Center Boston, Massachusetts  02114
Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Winship Cancer Institute of Emory University Atlanta, Georgia  30322