Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 31 of 40 for:    CARBAMAZEPINE AND Valproic Acid

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00068770
Recruitment Status : Terminated (EORTC trail showed TMZ & RT conferred significant survivial in this population)
First Posted : September 11, 2003
Results First Posted : March 18, 2015
Last Update Posted : March 18, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Tracking Information
First Submitted Date  ICMJE September 10, 2003
First Posted Date  ICMJE September 11, 2003
Results First Submitted Date  ICMJE November 19, 2012
Results First Posted Date  ICMJE March 18, 2015
Last Update Posted Date March 18, 2015
Study Start Date  ICMJE October 2003
Actual Primary Completion Date May 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 17, 2015)
Effects of Hepatic Enzyme Inducing Drugs Such as Anticonvulsants, on the PK of Celecoxib [ Time Frame: First dose of celecoxib through completion of radiation, 6 weeks. ]
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
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2015)
Overall Survival [ Time Frame: date pt started treatment to date pt last known alive ]
duration of survival when celecoxib is administered concurrently with radiation in pts with newly diagnosed glioblastoma multiforme
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Celecoxib in Patients With Newly Diagnosed GBM Who Are Receiving Anticonvulsant Drugs and Undergoing RT
Official Title  ICMJE A Pharmacokinetic Study of the Interaction Between Celecoxib and Anticonvulsant Drugs in Patients With Newly Diagnosed Glioblastoma Multiforme Undergoing Radiation Therapy
Brief 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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Brain and Central Nervous System Tumors
Intervention  ICMJE
  • Radiation: radiation therapy
    Radiation is standard treatment 6000cGy in 30 fractions. Patients will receive celecoxib 400 mg bid during RT treatment
    Other Name: RT
  • Drug: Celecoxib
    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.
    Other Name: Cox2
Study Arms  ICMJE
  • Active Comparator: 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)

    celecoxib and radiation therapy will be adminstered with this arm

    Interventions:
    • Radiation: radiation therapy
    • Drug: Celecoxib
  • Active Comparator: 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.

    celecoxib and radiation therapy will be adminstered with this arm

    Interventions:
    • Radiation: radiation therapy
    • Drug: Celecoxib
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 1, 2012)
35
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 2006
Actual Primary Completion Date May 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00068770
Other Study ID Numbers  ICMJE NABTT-2100 CDR0000328117
U01CA062475 ( U.S. NIH Grant/Contract )
NABTT-2100
JHOC-NABTT-2100
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Sponsor  ICMJE Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Stuart A. Grossman, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
PRS Account Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP