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. ]

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).


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 ]

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


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