RATIONALE: Drugs used in chemotherapy such as hydroxyurea use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well hydroxyurea works in treating patients with unresectable benign meningioma.
OBJECTIVES: * Determine the partial and complete response rates in patients with unresectable benign meningioma treated with hydroxyurea. * Assess the quantitative and qualitative toxic effects of this drug in this patient population. OUTLINE: Patients receive oral hydroxyurea twice daily for 2 years in the absence of disease progression or unacceptable toxicity. Patients are followed at 3 months, 6 months, and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 38 patients will be accrued for this study within 13 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
20 mg/kg/day PO
Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)
Complete Response (CR)is a complete disappearance of all measurable and evaluable disease. No new lesions, no disease related symptoms, no evidence of non-evaluable disease. Partial Response (PR)is greater than or equal to 50% decrease under baseline in sum of the products of perpendicular diameters of all measurable lesions. No progression of evaluable disease, no new lesions. Confirmation of CR or PR means a repeat scan at least 3 weeks apart documented before progression. No response means that patient did not achieve complete or partial response (either confirmed or unconfirmed).
Time frame: Patients treated for 2 years or progression. If responding can continue at physician's discretion.
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drug
Adverse Events (AEs) are reported by CTC 2.0 terminology. For each patient, worst grade of each event type is reported. Grade 3 - Severe, Grade 4 - Life-threatening, Grade 5 - Fatal
Time frame: Patients were assessed for adverse events 4 weeks after starting treatment. Assessments for adverse events continued every 3 months for the duration of protocol therapy. On average patients remained on therapy for 8 months
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