ClinicalTrials.gg
CompletedNCT00010049Updated Jun 27, 2018

Imatinib Mesylate in Treating Patients With Recurrent Malignant Glioma or Meningioma

A Phase 1/2 interventional study of imatinib mesylate in Brain and Central Nervous System Tumors, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. Completed at 11 sites in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2018-06-27.

Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Mar 2005, 21 years 7 months ago, and no results have been posted to the registry.
Phase
Phase 1/2
Study type
Interventional
Enrollment
105
Ages
18 Years to 120 Years
Sex
All
01

Study summary

RATIONALE: Imatinib mesylate may interfere with the growth of tumor cells and may be an effective treatment for recurrent glioma and meningioma.

PURPOSE: Phase I/II trial to study the effectiveness of imatinib mesylate in treating patients who have progressive, recurrent, or unresectable malignant glioma or meningioma.

Read the detailed description

OBJECTIVES:

  • Determine the maximum tolerated dose of imatinib mesylate in patients with recurrent malignant glioma or meningioma.
  • Determine the safety profile of this drug in these patients.
  • Determine the pharmacokinetics of this drug, with or without concurrent enzyme-inducing anti-epileptic drugs (EIAEDs), in these patients. (Stratum of patients currently taking EIAEDs closed to accrual as of 05/15/2003 for phase I and phase II)
  • Determine angiogenic activity in vivo using functional neuro-imaging studies and in vitro with assays of serum angiogenic peptides.
  • Determine the efficacy of this drug, in terms of 6-month progression-free survival and objective tumor response, in these patients.

OUTLINE: This is a multicenter, dose-escalation study. Patients are stratified according to concurrent enzyme-inducing anti-epileptic drug use (yes [stratum closed to accrual as of 05/15/2003 for phase I and phase II] vs no).

  • Phase I (patients with glioma or meningioma) Patients in cohorts 1 and 2 receive oral imatinib mesylate (STI571) once daily on days 1-28. Patients in cohorts 3-5 receive oral STI571 twice daily on days 1 and 3-28 of the first course and on days 1-28 of subsequent courses. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of STI571 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

  • Phase II (patients with glioma) (glioblastoma multiforme patients excluded as of 05/15/2003) Patients receive oral STI571 at the MTD determined in phase I, 1-2 times daily for 4 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for phase I of the study within 6 months and a total of 39 patients will be accrued for phase II of the study within 6-8 months. (Glioblastoma multiforme patients excluded from phase II as of 05/13/2003).

02

Conditions studied

  • Brain and Central Nervous System Tumors

Keywords

  • recurrent adult brain tumor
  • adult meningioma
  • adult glioblastoma
  • adult anaplastic astrocytoma
  • adult anaplastic oligodendroglioma
  • adult mixed glioma
  • adult pilocytic astrocytoma
  • adult subependymoma
  • adult grade III meningioma
  • adult giant cell glioblastoma
  • adult gliosarcoma
03

In context

Central Nervous System Neoplasms

684 studies on the registry are indexed under Central Nervous System Neoplasms; 68 are open to participants now.

This study's enrollment of 105 is above the median of 35 across 474 interventional studies indexed under Central Nervous System Neoplasms.

Browse Central Nervous System Neoplasms studies →

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins is the lead sponsor of 582 studies on the registry; 72 are open to participants now.

Of its 113 completed or terminated interventional studies of FDA-regulated products, 67 (59%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed recurrent or unresectable malignant glioma

    • Glioblastoma multiforme (phase I only)
    • Anaplastic astrocytoma
    • Anaplastic oligodendroglioma
    • Anaplastic mixed oligoastrocytoma
    • Malignant astrocytoma not otherwise specified
    • Gliosarcoma
    • Low-grade histology with subsequent diagnosis of malignant glioma allowed (phase I only) OR
  • Histologically confirmed recurrent or unresectable benign or malignant meningioma (phase I only)
  • No prior intracranial hemorrhage
  • Failed prior radiotherapy
  • Progressive or recurrent disease by MRI or CT scan and/or resection

    • PET or thallium scan, MR spectroscopy, or surgical documentation required in patients who have received prior interstitial brachytherapy or stereotactic radiosurgery
    • Stable dose of steroids for 5-7 days prior to MRI or CT scan

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • More than 8 weeks

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm\^3
  • Platelet count at least 100,000/mm\^3
  • Hemoglobin at least 10 g/dL (transfusion allowed)

Hepatic:

  • Bilirubin less than 2 times upper limit of normal (ULN)
  • SGOT less than 2 times ULN
  • No significant hepatic disease

Renal:

  • Creatinine less than 1.5 mg/dL
  • Creatinine clearance at least 60 mL/min
  • No significant renal disease

Cardiovascular:

  • No significant cardiac disease
  • No deep venous or arterial thrombosis within the past 6 weeks

Pulmonary:

  • No pulmonary embolism within the past 6 weeks

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for up to 6 months after study participation
  • No other serious concurrent medical illness
  • No serious active infection
  • No concurrent disease that would obscure toxicity or alter drug metabolism
  • No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 1 week since prior interferon or thalidomide and recovered
  • No concurrent immunotherapy
  • No concurrent prophylactic filgrastim (G-CSF)

Chemotherapy:

  • Recovered from prior chemotherapy
  • At least 4 weeks since prior cytotoxic therapy
  • At least 2 weeks since prior vincristine
  • At least 6 weeks since prior nitrosoureas
  • At least 4 weeks since prior temozolomide
  • At least 3 weeks since prior procarbazine
  • Prior polifeprosan 20 with carmustine implant (Gliadel wafer) allowed
  • Prior radiosensitizers allowed
  • No other concurrent chemotherapy
  • Phase I only:

    • Prior chemotherapy required for anaplastic astrocytoma, anaplastic oligodendroglioma, and anaplastic mixed oligoastrocytoma
    • Prior treatment for up to 3 relapses allowed
  • Phase II only:

    • Prior chemotherapy not required
    • Prior treatment for up to 2 relapses allowed

Endocrine therapy:

  • See Disease Characteristics
  • At least 1 week since prior tamoxifen and recovered
  • No concurrent anticancer hormonal therapy

Radiotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy
  • No concurrent radiotherapy

Surgery:

  • See Disease Characteristics
  • Recovered from prior surgical resection of recurrent or progressive disease

Other:

  • At least 1 week since prior non-cytotoxic agents and recovered
  • At least 1 week since prior tretinoin and recovered
  • At least 2 weeks since prior drugs that affect hepatic metabolism
  • No other concurrent investigational agents
  • No concurrent warfarin
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Intervention model
Parallel assignment
Enrollment
105 participants (actual)

Interventions

06

Study locations

11 sites
  • Jonsson Comprehensive Cancer Center, UCLA
    Los Angeles, California 90095-1781, United States
  • UCSF Comprehensive Cancer Center
    San Francisco, California 94143-0128, United States
  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
    Bethesda, Maryland 20892-1182, United States
  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
    Boston, Massachusetts 02115, United States
  • University of Michigan Comprehensive Cancer Center
    Ann Arbor, Michigan 48109-0316, United States
  • Memorial Sloan-Kettering Cancer Center
    New York, New York 10021, United States
  • Hillman Cancer Center at University of Pittsburgh Cancer Institute
    Pittsburgh, Pennsylvania 15232, United States
  • Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
    Dallas, Texas 75390-9154, United States
  • University of Texas - MD Anderson Cancer Center
    Houston, Texas 77030-4009, United States
  • University of Texas Health Science Center at San Antonio
    San Antonio, Texas 78284-6220, United States
  • University of Wisconsin Comprehensive Cancer Center
    Madison, Wisconsin 53792, United States
07

References and documents

Publications

  • Wen PY, Yung WK, Lamborn KR, Dahia PL, Wang Y, Peng B, Abrey LE, Raizer J, Cloughesy TF, Fink K, Gilbert M, Chang S, Junck L, Schiff D, Lieberman F, Fine HA, Mehta M, Robins HI, DeAngelis LM, Groves MD, Puduvalli VK, Levin V, Conrad C, Maher EA, Aldape K, Hayes M, Letvak L, Egorin MJ, Capdeville R, Kaplan R, Murgo AJ, Stiles C, Prados MD. Phase I/II study of imatinib mesylate for recurrent malignant gliomas: North American Brain Tumor Consortium Study 99-08. Clin Cancer Res. 2006 Aug 15;12(16):4899-907. doi: 10.1158/1078-0432.CCR-06-0773. PubMed 16914578 ↗
  • Wen PY, Yung WKA, Lamborn K, et al.: Phase I/II study of imatinib mesylate (ST1571) for patients with recurrent malignant gliomas (NABTC 99-08). [Abstract] Neuro-Oncology 6 (4): TA-63, 385, 2004.
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2001 to primary completion in Mar 2005, 48 months.

Of 33 phase 1/2 interventional studies under Central Nervous System Neoplasms, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 53 and three quarters within 85. This study's 48 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 2, 2001
First posted
Jan 27, 2003
StartActual
Feb 27, 2001
Primary completionActual
Mar 17, 2005
CompletionActual
Aug 15, 2006
Last update
Jun 27, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 27, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00010049
Responsible party
Sponsor
First posted
Jan 27, 2003
Start date
Feb 27, 2001
Primary completion
Mar 17, 2005
Completion
Aug 15, 2006
Last update
Jun 27, 2018

Study contacts

Patrick Y. Wen, MD
study chair · Dana-Farber Cancer Institute

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Imatinib

Start the discussion