Hydroxyurea With or Without Imatinib Mesylate in Treating Patients With Recurrent or Progressive Meningioma

  • STATUS
    Recruiting
  • participants needed
    76
  • sponsor
    Istituto Scientifico H. San Raffaele
Updated on 7 November 2020

Summary

RATIONALE: Drugs used in chemotherapy, such as hydroxyurea, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether hydroxyurea is more effective when given alone or together with imatinib mesylate in treating patients with meningioma. PURPOSE: This randomized phase II trial is studying how well hydroxyurea works compared with giving hydroxyurea together with imatinib mesylate in treating patients with recurrent or progressive meningioma.

Description

OBJECTIVES: Primary - Assess the progression-free survival of patients with recurrent or progressive meningiomas treated with hydroxyurea with vs without imatinib mesylate after surgery and radiotherapy. Secondary - Determine the overall survival, and response rate of patients treated with this regimen. - Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to WHO grade (I vs II-III). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral hydroxyurea twice daily and oral imatinib mesylate once daily in the absence of disease progression or unacceptable toxicity. - Arm II: Patients receive oral hydroxyurea twice daily in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed for up to 1 year.

Details
Treatment Imatinib Mesylate, hydroxyurea
Clinical Study IdentifierNCT00904735
SponsorIstituto Scientifico H. San Raffaele
Last Modified on7 November 2020

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