Clinical Trial: S9811 Hydroxyurea in Treating Patients With Unresectable Benign Meningioma
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase II Study of Hydroxyurea for Unresectable Meningioma
Brief 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.
Detailed Summary:
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.
Sponsor: Southwest Oncology Group
Current Primary Outcome: Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR) [ Time Frame: Patients treated for 2 years or progression. If responding can continue at physician's discretion. ]
Original Primary Outcome:
Current Secondary Outcome: Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drug [ 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 ]
Original Secondary Outcome:
Information By: Southwest Oncology Group
Dates:
Date Received: November 1, 1999
Date Started: November 1998
Date Completion:
Last Updated: April 20, 2016
Last Verified: April 2016