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

Phase 2
18 Years
Not Enrolling
Glioblastoma, Gliosarcoma

Thank you

Trial Information

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

This is an open-label, 2-stage, uncontrolled, non-randomized phase II study of continuous,
daily doses of imatinib mesylate & hydroxyurea in adult patients with recurrent or relapsing
meningioma. Treatment cycle is defined as imatinib mesylate & hydroxyurea administered daily
for 28 days for purpose of scheduling evaluations. All patients who receive 1 or more doses
of either imatinib mesylate or hydroxyurea will be evaluable for toxicity, whereas all
patients who receive minimum of 14 consecutive days of study regimen will be evaluable for
response. Patients who discontinue therapy prior to receiving 14 consecutive days of study
regimen will be regarded as ineligible for evaluation of response & will be replaced.

Inclusion Criteria:

- Patients with confirmed meningioma that is recurrent/progressive following prior
surgical resection

- Patients have measurable disease on MRI using gadolinium-enhanced T1 sequences

- Interval of >4 wks between prior XRT/chemo, & enrollment on protocol unless there is
unequivocal evidence of tumor progression & pt has recovered from all expected
toxicities associated w prior therapy. However, patients treated w chemo agents such
as VP-16 who would normally be retreated after shorter intervals may be treated at
usual starting time even if <4 wks from last prior dose of chemo

- Patients with tumor biopsy <1 week or surgical resection <2 weeks prior to starting
study drug

- Patients enrolling on arm B must be on >1 enzyme inducing anticonvulsants for >2 wks
prior to starting study drug

- Patients should be on non-increasing dose of steroids for >7 days prior to obtaining
baseline Gd-MRI of brain

- Patients should be on non-increasing dose of steroids for >7 days prior to starting
study drug

- Multifocal disease is eligible

- Age > 18yrs old

- KPS of > 60

- Patients must have following laboratory values:

- Hematology:

- ANC > 1.5 x 10^9/L

- Hgb> 9 g/dL

- Platelets>100 x 10^9/L

- Biochemistry:

- K≥ LLN/correctable w supplement

- Total Ca ≥ LLN/correctable with supplement

- P ≥ LLN/correctable w supplement


- Serum bilirubin < 1.5 x ULN

- Serum creatinine ,1.5 x ULN/measured 24hr CrCl> 50 mL/min/1.73m2

- Life expectancy ≥ 12wks

- Written informed consent obtained prior to any screening procedures

Exclusion Criteria:

- Prior progressive disease/toxicity gr ≥3 w prior hydroxyurea therapy

- Prior treatment with imatinib/other PDGF-directed therapy

- Excessive risk of bleeding as defined by stroke<6 months, history of CNS/intraocular
bleed,septic endocarditis

- Evidence of intratumor hemorrhage on pretreatment diagnostic imaging, except for
stable post-operative gr1 hemorrhage

- Female patients who are pregnant/breast feeding,/adults of reproductive potential not
employing effective method of birth control

- Concurrent severe and/or uncontrolled medical disease that could compromise
participation in study

- Acute/chronic liver disease

- Confirmed diagnosis of HIV infection

- Impairment of GI function or GI disease that may significantly alter absorption of

- Patients who are taking Coumadin

- Patients who have received investigational drugs <2wks prior to entry on this study
or who have not recovered from the toxic effects of such therapy

- Patients who have received biologic, immunotherapeutic or cytostatic agents within
1wk prior to entry on this study/who have not recovered from toxic effects of such

- Patient ≤ 5 yrs free of another primary malignancy except: if other primary
malignancy is not currently clinically significant/requiring active intervention,/if
other primary malignancy is basal cell skin cancer/ cervical carcinoma in situ.
Existence of any other malignant disease is not allowed

- Patients who have had any surgery other than resection of brain tumor < 2 wks prior
to entry on this study/who have not recovered from side effects of such therapy

- Patients unwilling to/unable to comply with protocol

- Active systemic bleeding, such as GI bleeding/gross hematuria

- Gr 2/greater peripheral edema/central/systemic fluid collections

- Patients who enroll on arm A must have not received any EIAC for at >wks prior to
starting study regimen

- Any of following exclusion criteria to MRI imaging:

- Cardiac pacemaker

- Ferromagnetic metal implants other than those approved as safe for use in MR

- Claustrophobia

- Obesity

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate length progression free survival

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

David A. Reardon, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University Health System


United States: Institutional Review Board

Study ID:




Start Date:

May 2005

Completion Date:

October 2010

Related Keywords:

  • Glioblastoma
  • Gliosarcoma
  • Glioblastoma
  • Gliosarcoma
  • GBM
  • Brain tumor
  • Imatinib
  • Imatinib mesylate
  • Hydroxyurea
  • Droxia
  • Hydrea
  • Hydroxycarbamide
  • Gleevec
  • Meningioma
  • Glioblastoma
  • Meningioma
  • Gliosarcoma



Duke University Health System Durham, North Carolina  27705