S9811 Hydroxyurea in Treating Patients With Unresectable Benign Meningioma
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|ClinicalTrials.gov Identifier: NCT00003590|
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : February 16, 2012
Last Update Posted : May 20, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Adult Meningioma||Drug: hydroxyurea||Phase 2|
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Hydroxyurea for Unresectable Meningioma|
|Study Start Date :||November 1998|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||July 2011|
20 mg/kg/day PO
- 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).
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003590
|Study Chair:||Lode J. Swinnen, MD||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Study Chair:||Geoffrey R. Barger, MD||Barbara Ann Karmanos Cancer Institute|