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Brain and Central Nervous System TumorsPhase 2NCT00068770

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

A Phase 2 study testing radiation therapy and Celecoxib in people with Brain and Central Nervous System Tumors, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 7 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brain and Central Nervous System Tumors
What is being tested?
radiation therapy and Celecoxib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
7 sitesUnited States
Study dates
Oct 2003to May 2006
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231-2410

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114-2617

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Abramson Cancer Center of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104-4283

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612-9497

  • Comprehensive Cancer Center at Wake Forest University

    Winston-Salem, North Carolina, 27157-1030

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
radiation therapy, Celecoxib
Keywords
adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma
Medical subject headings
Central Nervous System Neoplasms, Glioblastoma, Gliosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • radiation therapyRadiation

    Also called RT

    Radiation is standard treatment 6000cGy in 30 fractions. Patients will receive celecoxib 400 mg bid during RT treatment

  • CelecoxibDrug

    Also called Cox2

    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.

Study groups in NCT00068770
Study groupRoleWhat they receive
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
Receives: Radiation: radiation therapy; Drug: Celecoxib
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
Receives: Radiation: radiation therapy; Drug: Celecoxib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: First dose of celecoxib through completion of radiation, 6 weeks.

Secondary outcomes (1)

  1. Overall Survival

    duration of survival when celecoxib is administered concurrently with radiation in pts with newly diagnosed glioblastoma multiforme

    Measured: date pt started treatment to date pt last known alive

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2003 (estimated)
  2. Study startOct 2003
  3. Primary completionMay 2005
  4. Study completionMay 2006

Why it stopped: EORTC trail showed TMZ \& RT conferred significant survivial in this population

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00068770
Sponsor's protocol ID
NABTT-2100 CDR0000328117
Other IDs
U01CA062475, NABTT-2100, JHOC-NABTT-2100
Status last verified
Mar 2015
First submitted
10 Sep 2003
Last updated
18 Mar 2015
Data monitoring committee
Yes

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.

    PubMed 18287342

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing radiation therapy and Celecoxib in people with Brain and Central Nervous System Tumors, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00068770, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2015.

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