S9811 Hydroxyurea in Treating Patients With Unresectable Benign Meningioma

Adult Meningioma Clinical Trial

Official title: Phase II Study of Hydroxyurea for Unresectable Meningioma

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adult Meningioma
• Meningioma

• NCT number: NCT00003590
• Study type: Interventional
• Source: Southwest Oncology Group
• Status: Completed
• Phase: Phase 2
• Start date: November 1998
• Completion date: July 2011