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

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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

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Brain and Central Nervous System Tumors
Interventions: Radiation: radiation therapy
Drug: Celecoxib

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
pts were enrolled on this study from October 2003 to September 2004. Pts were enrolled in an outpatient clinical setting

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
pts were assigned to an arm at the time of enrollment

Reporting Groups
  Description
nonp450

not on p450 inhibitor

celecoxib :

radiation therapy :

p450

on p450 inhibitor

celecoxib :

radiation therapy :


Participant Flow:   Overall Study
    nonp450   p450
STARTED   13   22 
COMPLETED   13   22 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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)
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.
Total Total of all reporting groups

Baseline Measures
   p450 ( +EIASD)   nonp450 (-EIASD)   Total 
Overall Participants Analyzed 
[Units: Participants]
 22   13   35 
Age 
[Units: Years]
Mean (Standard Deviation)
 58  (12)   56  (17)   57  (26) 
Gender 
[Units: Participants]
     
Female   8   7   15 
Male   14   6   20 
Karnofsky Perfomance Status (KPS) [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 88  (11)   83  (9)   86  (10) 
[1] 100 normal no complaints no disease 90 capable of normal activity few symptoms/disease 80 normal activity with some difficulty some symptoms or signs 70 caring for self not capable of normal activity or work 60 requiring some help can take care of most personal requirements 50 requires help often requires frequent medical care 40 disabled requires special care and help 30 severely disabled hospital admission indicated but no risk of death 20 very ill urgently requiring admission requires supportive measures or treatment 10 moribund rapidly progressive fatal disease processes 0 death
Mini Mental State Exam Score [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 28  (4)   28  (3)   28  (3) 
[1] The mini–mental state examination (MMSE) is a 30-point questionnaire test used to screen for cognitive impairment. Commonly used to screen for dementia. It is also used to estimate the severity of cognitive impairment and to follow the course of cognitive changes in an individual over time. The MMSE test includes simple questions and problems in a number of areas: the time and place of the test, repeating lists of words, arithmetic such as the serial sevens, language use and comprehension, and basic motor skills. The Higher your score, the higher your function.
Corticosteroid therapy [1] 
[Units: Participants]
     
Yes   18   11   29 
No   4   2   6 
[1] Patients on corticpsteroid therapy
Prior Surgery [1] 
[Units: Participant]
     
Craniotomy   21   10   31 
Biopsy   1   3   4 
[1] Whether pt had Craniotomy or Biopsy


  Outcome Measures

1.  Primary:   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. ]

2.  Secondary:   Overall Survival   [ Time Frame: date pt started treatment to date pt last known alive ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study ended early when results from another study became available documenting Temozolomide (TMZ) and radiation improved survival, we felt it was unethical to continue this study, our study did not include TMZ.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Stuart A Grossman
Organization: Johns Hopkins University
phone: 410-955-3657
e-mail: jfisher@jhmi.edu


Publications:

Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT00068770     History of Changes
Other Study ID Numbers: NABTT-2100 CDR0000328117
U01CA062475 ( U.S. NIH Grant/Contract )
NABTT-2100
JHOC-NABTT-2100
First Submitted: September 10, 2003
First Posted: September 11, 2003
Results First Submitted: November 19, 2012
Results First Posted: March 18, 2015
Last Update Posted: March 18, 2015