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S9811 Hydroxyurea in Treating Patients With Unresectable Benign Meningioma

This study has been completed.
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Information provided by (Responsible Party):
Southwest Oncology Group Identifier:
First received: November 1, 1999
Last updated: April 20, 2016
Last verified: April 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 Intervention Phase
Adult Meningioma Drug: hydroxyurea Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Hydroxyurea for Unresectable Meningioma

Resource links provided by NLM:

Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • 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:
  • 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

Enrollment: 29
Study Start Date: November 1998
Study Completion Date: July 2011
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hydroxyurea Drug: hydroxyurea
20 mg/kg/day PO

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.


Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00003590

  Show 133 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Study Chair: Lode J. Swinnen, MD Sidney Kimmel Comprehensive Cancer Center
Study Chair: Geoffrey R. Barger, MD Barbara Ann Karmanos Cancer Institute
  More Information

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.

Responsible Party: Southwest Oncology Group Identifier: NCT00003590     History of Changes
Other Study ID Numbers: CDR0000066659
S9811 ( Other Identifier: SWOG )
ECOG-S9811 ( Other Identifier: ECOG )
U10CA032102 ( U.S. NIH Grant/Contract )
Study First Received: November 1, 1999
Results First Received: November 7, 2011
Last Updated: April 20, 2016

Keywords provided by Southwest Oncology Group:
recurrent adult brain tumor
adult grade I meningioma

Additional relevant MeSH terms:
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 processed this record on July 26, 2017