Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Hydroxyurea in Treating Patients With Recurrent and/or Unresectable Meningioma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 16 and over Other FRE-FNCLCC-98009 EU-20018, NCT00006119

Objectives

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

Entry Criteria

Disease Characteristics:

• Histologically proven progressive meningioma that is not curable by surgery

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

Patient Characteristics:

Age:

• 16 and over

Performance status:

• Karnofsky 70-100%

Life expectancy:

• Over 3 months

Hematopoietic:

• WBC at least 3,000/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Federation Nationale des Centres de Lutte Contre le Cancer

Didier Frappaz, MD, Protocol chair		Ph: 33-4-78-782881 Email: frappa2@lyon.fnclcc.fr

Registry Information
Official Title		Phase II Study of Hydroxyurea for the Treatment of Recurrent and/or Nonoperable Meningioma
Trial Start Date		1999-07-15
Registered in ClinicalTrials.gov		NCT00006119
Date Submitted to PDQ		2000-07-05
Information Last Verified		2004-12-02

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