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GlioblastomaPhase 2NCT00354913

Imatinib Mesylate and Hydroxyurea in Treating Patients With Recurrent or Progressive Meningioma

A Phase 2 study testing hydroxyurea and imatinib mesylate in people with Glioblastoma and Gliosarcoma, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as hydroxyurea, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glioblastoma, Gliosarcoma
What is being tested?
hydroxyurea and imatinib mesylate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
May 2005to Oct 2010
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 meningioma
  • Recurrent or progressive disease after prior surgical resection
  • Measurable disease by contrast-enhanced MRI
  • Multifocal disease allowed
  • No evidence of intratumor hemorrhage on pretreatment diagnostic imaging
  • Stable postoperative grade 1 hemorrhage allowed
  • No peripheral edema or central or systemic fluid collections ≥ grade 2 (e.g., pericardial effusion, pulmonary effusion, ascites)

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 70-100%
  • Absolute neutrophil count > 1,500/mm³
  • Hemoglobin > 9 g/dL
  • Platelet count > 100,000/mm³
  • Potassium normal*
  • Calcium normal*
  • Magnesium normal*
  • Phosphorus normal*
  • alanine aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 times upper limit of normal (ULN)
  • Bilirubin < 1.5 times ULN
  • Creatinine < 1.5 times ULN OR creatinine clearance > 50 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No excessive risk of bleeding, as defined by stroke within the past 6 months
  • No active systemic bleeding (i.e., gastrointestinal bleeding or gross hematuria)
  • No history of central nervous system (CNS) or intraocular bleeding or septic endocarditis
  • No concurrent severe and/or uncontrolled medical disease, including any of the following:
  • Uncontrolled diabetes
  • Congestive cardiac failure
  • Myocardial infarction within the past 6 months
  • Poorly controlled hypertension
  • History of labile hypertension
  • History of poor compliance with antihypertensive regimen
  • Chronic renal disease
  • Active uncontrolled infection requiring intravenous antibiotics
  • No acute or chronic liver disease (i.e., hepatitis, cirrhosis)
  • No HIV positivity
  • No impairment of gastrointestinal function or disease that may significantly alter the absorption of imatinib mesylate, including any of the following:
  • Ulcerative disease
  • Uncontrolled nausea
  • Vomiting
  • Diarrhea
  • Malabsorption syndrome
  • Bowel obstruction
  • Inability to swallow tablets
  • No other malignancy within the past 5 years except basal cell skin cancer or cervical carcinoma in situ NOTE: *Unless correctable with supplements

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from prior therapy
  • More than 1 week since prior tumor biopsy
  • More than 2 weeks since prior surgical resection
  • Prior hydroxyurea allowed provided patient has not had progressive disease or toxicity > grade 3
  • No prior imatinib mesylate or other platelet-derived growth factor-directed therapy
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)*
  • Chemotherapeutic agents such as etoposide that are normally given at shorter intervals allowed even if < 4 weeks from last prior dose of chemotherapy
  • At least 4 weeks since prior radiotherapy*
  • At least 1 week since prior biological, immunotherapeutic, or cytostatic drugs
  • At least 2 weeks since prior investigational drugs
  • No concurrent warfarin NOTE: *Unless there is unequivocal evidence of tumor progression

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Duke Cancer Institute

    Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: A Phase II Study of Imatinib Mesylate Plus Hydroxyurea in the Treatment of Patients With Recurrent/Progressive Meningioma

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as hydroxyurea, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving imatinib mesylate together with hydroxyurea may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving imatinib mesylate together with hydroxyurea works in treating patients with recurrent or progressive meningioma.

Read the detailed description

OBJECTIVES:

Primary

  • Evaluate the activity of imatinib mesylate and hydroxyurea, as measured by 6-month progression-free survival, in patients with recurrent or progressive meningioma.

Secondary

  • Evaluate the progression-free survival (PFS)
  • Overall survival (OS),
  • Objective response rate among patients treated with this regimen.

OUTLINE: This is an open-label study.

Patients receive oral imatinib mesylate once or twice daily and oral hydroxyurea twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 21 patients will be accrued for this study.

Being tested
hydroxyurea, imatinib mesylate
Keywords
adult grade I meningioma, adult grade II meningioma, adult grade III meningioma, adult papillary meningioma, adult anaplastic meningioma, recurrent adult brain tumor, glioblastoma multiforme (GBM), Imatinib, Imatinib mesylate, Hydroxyurea, Droxia, Hydrea, Hydroxycarbamide, Gleevec, Meningioma
Medical subject headings
Glioblastoma, Gliosarcoma, Meningioma, Brain Neoplasms

What participants receive

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

  • hydroxyureaDrug

    Also called Droxia, Hydrea, Hydroxycarbamide

    Hydroxyurea is administered orally twice a day. The dose will be set at 500 mg twice a day for all patients. If vomiting occurs not additional trial medication should be taken that day in an effort to replace the material that has been vomited. It is recommended that patients take their prescribed hydroxyurea at the same time that they take their prescribed imatinib mesylate, however, a 30-60 minute interval between agents is acceptable, if required for practical or other compliance issues.

  • imatinib mesylateDrug

    Also called Gleevec

    Imatinib administered orally on daily, continuous basis. Imatinib doses of 400mg/600mg administered once daily, whereas daily doses of 800mg/greater administered as equally divided dose taken twice day.

    Dose for Imatinib:

    Patients receiving p450-inducing antiepileptic drugs:500mg twice day Patients not receiving p450-inducing antiepileptic drugs:400mg/day.

    If patients who were not on Cytochrome P450, family 3, subfamily A (CYP3A) enzyme-reducing anti-epileptic drug (EIAED) when originally enrolled must initiate CYP3A enzyme-inducing anti-epileptic drug while on study, study regimen will remain same for minimum of 2 wks before pt transitions to dosing as specified for patients on anti-epileptic drug. If patients originally enrolled must discontinue all EIAEDs while on study, in interest of patient safety, dosing of study regimen will transition to that of patients not on anti-epileptics immediately.

Study groups in NCT00354913
Study groupRoleWhat they receive
Imatinib mesylate+hydroxyureaExperimentalAll patients receive imatinib mesylate and hydroxyurea orally on a daily, continuous basis. Dosing of imatinib mesylate is adjusted for patients who are also receiving p450-inducing anti-epileptic drugs.
Receives: Drug: hydroxyurea; Drug: imatinib mesylate

What is being measured

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

  1. Progression-free Survival at 6 Months

    Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or death due to any cause.

    Measured: From the date of study treatment initiation to the date of the first documented progression or death from any cause, whichever came first, assessed up to 69 months. For each participant, PFS was assessed at 6 months after treatment initiation.

Secondary outcomes (3)

  1. Median Progression-free Survival (PFS)

    Time in months from the start of study treatment to the date of first progression according to Macdonald criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.

    Measured: From the date of study treatment initiation to the date of the first documented progression or death from any cause, whichever came first, assessed up to 69 months.

  2. Median Overall Survival (OS)

    Time in months from the start of study treatment to date of death due to any cause. Patients alive at last follow-up are censored as of that follow-up date. Median OS was estimated using a Kaplan-Meier curve.

    Measured: From the date of study treatment initiation to the date of death from any cause, assessed up to 69 months.

  3. Objective Response Rate

    Percentage of participants with an objective response (complete response or partial response). Per modified Macdonald criteria and assessed by MRI, complete response (CR) was the disappearance of all target lesions and partial response (PR) was a ≥50% decrease in the sum of the longest diameter of target lesions. Objective response = CR+PR.

    Measured: 69 Months

Timeline

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

  1. First posted20 Jul 2006 (estimated)
  2. Study startMay 2005
  3. Primary completionMar 2009
  4. Study completionOct 2010

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00354913
Sponsor's protocol ID
Pro00006768
Other IDs
DUMC-7082-05-4R0, NOVARTIS-DUMC-7082-05-4R0
Status last verified
Dec 2012
First submitted
19 Jul 2006
Last updated
18 Jan 2013
Data monitoring committee
Yes

Publications

  • Reardon DA, Norden AD, Desjardins A, Vredenburgh JJ, Herndon JE 2nd, Coan A, Sampson JH, Gururangan S, Peters KB, McLendon RE, Norfleet JA, Lipp ES, Drappatz J, Wen PY, Friedman HS. Phase II study of Gleevec(R) plus hydroxyurea (HU) in adults with progressive or recurrent meningioma. J Neurooncol. 2012 Jan;106(2):409-15. doi: 10.1007/s11060-011-0687-1. Epub 2011 Sep 22.

    PubMed 21938530

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing hydroxyurea and imatinib mesylate in people with Glioblastoma and Gliosarcoma, run by Duke University at 1 site 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: finished, as of the sponsor's last update on 18 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 14 Jan 2013). 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?

Progression-free Survival at 6 Months (time frame: From the date of study treatment initiation to the date of the first documented progression or death from any cause, whichever came first, assessed up to 69 months. For each participant, PFS was assessed at 6 months after treatment initiation.). 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 NCT00354913, 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 Jan 2013.

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