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S9811 Hydroxyurea in Treating Patients With Unresectable Benign Meningioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003590
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : February 16, 2012
Last Update Posted : May 20, 2016
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Information provided by (Responsible Party):
Southwest Oncology Group

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.

Condition or disease Intervention/treatment Phase
Adult Meningioma Drug: hydroxyurea Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Hydroxyurea

Arm Intervention/treatment
Experimental: Hydroxyurea Drug: hydroxyurea
20 mg/kg/day PO

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed unresectable primary, recurrent, or residual benign meningioma
  • Measurable disease by CT scan or MRI
  • Must have disease progression within the past 10 years OR progressive neurologic deficit within the past 6 months
  • Must have undergone prior radiotherapy with subsequent disease progression OR refused radiotherapy



  • 18 and over

Performance status:

  • SWOG 0-2

Life expectancy:

  • Not specified


  • WBC at least 4,000/mm^3
  • Platelet count at least lower limit of normal


  • Not specified


  • Not specified


  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except adequately treated basal or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission


Biologic therapy:

  • Not specified


  • No prior cytotoxic chemotherapy for meningioma
  • Prior mifepristone allowed
  • No other concurrent chemotherapy

Endocrine therapy:

  • Concurrent glucocorticoids and hormone replacement therapy allowed if stable dose maintained for at least 72 hours prior to CT scan or MRI
  • No concurrent antitumor hormonal therapy


  • See Disease Characteristics
  • At least 6 months since prior radiotherapy
  • No concurrent radiotherapy


  • Not specified

Information from the National Library of Medicine

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 identifier (NCT number): NCT00003590

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Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
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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
Publications of Results:
Swinnen LJ, Rankin C, Rushing EJ, et al.: Phase II study of hydroxyurea for unresectable meningioma (Southwest Oncology Group S9811). [Abstract] J Clin Oncol 27 (Suppl 15): A-2063, 2009.

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Responsible Party: Southwest Oncology Group Identifier: NCT00003590    
Other Study ID Numbers: CDR0000066659
S9811 ( Other Identifier: SWOG )
ECOG-S9811 ( Other Identifier: ECOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Results First Posted: February 16, 2012
Last Update Posted: May 20, 2016
Last Verified: April 2016
Keywords provided by Southwest Oncology Group:
recurrent adult brain tumor
adult grade I meningioma
Additional relevant MeSH terms:
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Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms, Vascular Tissue
Meningeal Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Antineoplastic Agents
Antisickling Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors