Hydroxyurea in Treating Patients With Recurrent and/or Unresectable Meningioma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

1999-07-31

Study Completion Date

2008-01-31

Brief Summary

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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of hydroxyurea in treating patients who have recurrent and/or unresectable meningioma.

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Detailed Description

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OBJECTIVES:

* Determine complete, partial, or stable response to hydroxyurea in patients with recurrent and/or nonresectable meningioma.
* Determine response at 2 years to this regimen in these patients.
* Determine overall and disease free survival of these patients after this regimen.
* Determine quality of life of these patients.
* Determine the toxicities of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to grade of disease (I vs II or III).

Patients receive oral hydroxyurea daily for 2 years.

Quality of life is assessed before treatment, then every 3 months for 2 years.

PROJECTED ACCRUAL: A total of 60 patients (30 per stratum) will be accrued for this study.

Conditions

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Brain and Central Nervous System Tumors

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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hydroxyurea

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Histologically proven progressive meningioma that is not curable by surgery

PATIENT CHARACTERISTICS:

Age:

* 16 and over

Performance status:

* Karnofsky 70-100%

Life expectancy:

* Over 3 months

Hematopoietic:

* WBC at least 3,000/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* Bilirubin no greater than 2 times upper limit of normal (ULN)
* AST and ALT no greater than 2 times ULN
* Alkaline phosphatase no greater than 2 times ULN

Renal:

* Creatinine no greater than 2 times ULN

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 6 months after study
* No other malignancy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No prior chemotherapy
* No other concurrent chemotherapy

Endocrine therapy:

* Concurrent corticosteroids allowed for control of intracranial pressure

Radiotherapy:

* Prior radiotherapy allowed
* No concurrent radiotherapy

Surgery:

* See Disease Characteristics

Other:

* At least 1 year since prior experimental therapy

Minimum Eligible Age

16 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No