Study Stopped
EORTC trail showed TMZ \& RT conferred significant survivial in this population
Celecoxib in Patients With Newly Diagnosed GBM Who Are Receiving Anticonvulsant Drugs and Undergoing RT
A Pharmacokinetic Study of the Interaction Between Celecoxib and Anticonvulsant Drugs in Patients With Newly Diagnosed Glioblastoma Multiforme Undergoing Radiation Therapy
4 other identifiers
interventional
35
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2003
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 10, 2003
CompletedFirst Posted
Study publicly available on registry
September 11, 2003
CompletedStudy Start
First participant enrolled
October 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2006
CompletedResults Posted
Study results publicly available
March 18, 2015
CompletedMarch 18, 2015
March 1, 2015
1.6 years
September 10, 2003
November 19, 2012
March 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effects of Hepatic Enzyme Inducing Drugs Such as Anticonvulsants, on the PK of Celecoxib
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
First dose of celecoxib through completion of radiation, 6 weeks.
Secondary Outcomes (1)
Overall Survival
date pt started treatment to date pt last known alive
Study Arms (2)
p450 ( +EIASD)
ACTIVE COMPARATORon 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
nonp450 (-EIASD)
ACTIVE COMPARATORnot 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 is standard treatment 6000cGy in 30 fractions. Patients will receive celecoxib 400 mg bid during RT treatment
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.
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (7)
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
Related Publications (1)
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.
PMID: 18287342BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
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.
Results Point of Contact
- Title
- Dr. Stuart A Grossman
- Organization
- Johns Hopkins University
Study Officials
- STUDY CHAIR
Stuart A. Grossman, MD
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2003
First Posted
September 11, 2003
Study Start
October 1, 2003
Primary Completion
May 1, 2005
Study Completion
May 1, 2006
Last Updated
March 18, 2015
Results First Posted
March 18, 2015
Record last verified: 2015-03