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IMATINIB Plus Hydroxyurea in the Treatment of Recurrent or Progressive Meningiomas: a Randomized Phase II Study


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Brain and Central Nervous System Tumors

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Trial Information

IMATINIB Plus Hydroxyurea in the Treatment of Recurrent or Progressive Meningiomas: a Randomized Phase II Study


OBJECTIVES:

Primary

- Assess the progression-free survival of patients with recurrent or progressive
meningiomas treated with hydroxyurea with vs without imatinib mesylate after surgery
and radiotherapy.

Secondary

- Determine the overall survival, and response rate of patients treated with this
regimen.

- Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to WHO grade (I vs
II-III). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral hydroxyurea twice daily and oral imatinib mesylate once
daily in the absence of disease progression or unacceptable toxicity.

- Arm II: Patients receive oral hydroxyurea twice daily in the absence of disease
progression or unacceptable toxicity.

After completion of study therapy, patients are followed for up to 1 year.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosed with meningioma

- WHO grade I-III

- Recurrent or progressive disease after prior surgery and radiotherapy, or
radiosurgery

- Not amenable to further surgery

- No optic nerve sheet tumor and neurofibromatosis type II

- No known brain metastasis

PATIENT CHARACTERISTICS:

- WHO performance status 0-2

- ANC > 1,500/mm^3

- Platelet count > 100,000/mm^3

- Hemoglobin ≥ 9 mg/dL (transfusion allowed)

- Total bilirubin < 1.5 times upper limit of normal (ULN)

- SGOT and SGPT < 2.5 times ULN

- Creatinine < 1.5 times ULN

- Negative pregnancy test

- Fertile patients must use effective barrier method contraception during and for up to
3 months after completion of study therapy

- No second malignancy

- No known chronic liver disease (i.e., active hepatitis, cirrhosis)

- No known HIV infection

- No significant history of non-compliance to medical regimens or inability to grant
reliable informed consent

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No concurrent enzyme-inducing anti-epileptic drugs

- No concurrent therapeutic anticoagulation with warfarin (e.g., Coumadin®)

- Low-molecular weight heparin (e.g., Lovenox) or heparin allowed

- Mini-dose Coumadin® (e.g., 1 mg QD) allowed for prophylaxis of central venous
catheter thrombosis, at the discretion of the treating physician

- No concurrent acetaminophen (Efferalgan®, Tachipirina®) allowed during imatinib
mesylate administration

- No other concurrent anticancer agents, including chemotherapy or biological agents

- No other concurrent investigational drugs

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival, defined as ≥ 25% increase in tumor volume or new tumor on MRI

Safety Issue:

No

Principal Investigator

Alba A. Brandes, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Ospedale Bellaria

Authority:

Unspecified

Study ID:

CDR0000641101

NCT ID:

NCT00904735

Start Date:

June 2009

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult grade I meningioma
  • adult grade II meningioma
  • adult anaplastic meningioma
  • adult papillary meningioma
  • recurrent adult brain tumor
  • Meningioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

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