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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

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Trial Information

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



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


- 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.

Inclusion Criteria


- 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)


- 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

- No concurrent severe and/or uncontrolled medical disease, including any of the

- 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


- 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

Type of Study:


Study Design:

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

Outcome Measure:

Progression-free Survival at 6 Months

Outcome Description:

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.

Outcome 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.

Safety Issue:


Principal Investigator

David A. Reardon, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

May 2005

Completion Date:

October 2010

Related Keywords:

  • Glioblastoma
  • Gliosarcoma
  • 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
  • Glioblastoma
  • Meningioma
  • Gliosarcoma



Duke Cancer InstituteDurham, North Carolina  27710