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Phase II Study of Imatinib Mesylate Plus Hydroxyurea in the Treatment of Patients With Recurrent / Progressive Grade II Low-Grade Glioma

Phase 2
18 Years
Not Enrolling
Glioblastoma, Gliosarcoma

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Trial Information

Phase II Study of Imatinib Mesylate Plus Hydroxyurea in the Treatment of Patients With Recurrent / Progressive Grade II Low-Grade Glioma

This is an open-label, single stage, uncontrolled, non-randomized Phase II study of
continuous, daily doses of imatinib mesylate & hydroxyurea in adult patients with
progressive/recurrent Grade II low-grade glioma (LGG). The 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 a 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 and will be replaced.

Inclusion Criteria:

- Patients with grade II LGG that is recurrent/progressive following prior surgical
resection while on non-decreasing dose of corticosteroids

- > 25percent enlargement of bidimensional measure/new lesions on sequential imaging
new &/or worsening neurologic deficits

- Patients with progressive/recurrent optic pathway tumors

- Patients have measurable disease on MRI/CT

- Interval of > 4 wks between prior external beam radiation therapy (XRT)/chemo,&
enrollment on protocol unless there is unequivocal evidence of tumor progression &
patient has recovered from all expected toxicities associated with prior therapy.
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 not have had tumor biopsy < 1 wk/surgical resection < 2 wks 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 > 18 yrs old

- Karnofsky Performance Status (KPS) of > 60

- absolute neutrophil count (ANC) > 1.5 x 10 9/L

- Hgb > 9 g/dL

- Platelets > 100 x 10 9/L

- K ≥ lower limit of normal (LLN)/correctable with supplements

- Ca ≥ LLN/correctable with supplements

- P ≥ LLN/correctable with supplements

- aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) &
Alanine transaminase (ALT)/ Serum Glutamic Pyruvate Transaminase (SGPT} < 2.5 x ULN

- Serum bilirubin < 1.5 x upper limit of normal (ULN)

- Serum creatinine < 1.5 x ULN/measured 24hr Creatinine Clearance > 50 mL/min/1.73m2

- Life expectancy ≥ 12wks

- Written informed consent obtained prior to screening procedures

Exclusion Criteria:

- Prior progressive disease/toxicity grade ≥ 3 with prior hydroxyurea therapy

- Prior treatment with imatinib/other platelet derived growth factor (PDGF)-directed

- Excessive risk of bleeding as defined by stroke < 6 months, history of central
nervous system (CNS)/intraocular bleed, or septic endocarditis

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

- 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/GI disease that may significantly alter absorption of

- Patients taking Coumadin

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

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

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

- Patients have had any surgery other than resection of brain tumor < 2 wks prior to
entry on study/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

- Gr2 /> peripheral edema/central/systemic fluid collections

- Patients who enroll on arm A must have not received any EIAC for > 2 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
magnetic resonance (MR) scanners

- 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:

12-month Progression Free Survival (PFS)

Outcome Description:

Percentage of participants surviving twelve months from the start of cycle 1 without progression of disease. PFS was defined as the time from the cycle 1 start date to the date of the first documented progression according to modified Macdonald criteria, or to death due to any cause.

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Annick Desjardins, MD, FRCPC

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University Health System


United States: Institutional Review Board

Study ID:




Start Date:

February 2006

Completion Date:

June 2012

Related Keywords:

  • Glioblastoma
  • Gliosarcoma
  • Glioblastoma
  • Gliosarcoma
  • glioblastoma multiforme (GBM)
  • GBM
  • Imatinib Mesylate
  • Gleevec
  • Hydroxyurea
  • Droxia
  • Hydrea
  • Hydroxycarbamide
  • Imatinib
  • Brain tumor
  • Malignant brain tumor
  • Recurrent glioblastoma multiforme
  • Progressive glioblastoma multiforme
  • Glioblastoma
  • Gliosarcoma



Duke University Health SystemDurham, North Carolina  27705