S9811 Hydroxyurea in Treating Patients With Unresectable Benign Meningioma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase II Study of Hydroxyurea for Unresectable Meningioma

Conditions
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Adult Meningioma

Intervention / Treatment
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* Drug: hydroxyurea


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed unresectable primary, recurrent, or residual benign meningioma Measurable disease by CT scan or MRI Must have disease progression within the past 10 years OR progressive neurologic deficit within the past 6 months Must have undergone prior radiotherapy with subsequent disease progression OR refused radiotherapy PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 4,000/mm^3 Platelet count at least lower limit of normal Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing Fertile patients must use effective contraception No other malignancy within the past 5 years except adequately treated basal or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior cytotoxic chemotherapy for meningioma Prior mifepristone allowed No other concurrent chemotherapy Endocrine therapy: Concurrent glucocorticoids and hormone replacement therapy allowed if stable dose maintained for at least 72 hours prior to CT scan or MRI No concurrent antitumor hormonal therapy Radiotherapy: See Disease Characteristics At least 6 months since prior radiotherapy No concurrent radiotherapy Surgery: Not specified

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydroxyurea<br> | Drug: hydroxyurea<br>* 20 mg/kg/day PO<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Patients treated for 2 years or progression. If responding can continue at physician's discretion. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent adult brain tumor, adult grade I meningioma