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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00904735
First received: May 19, 2009
Last updated: August 9, 2013
Last verified: July 2009

May 19, 2009
August 9, 2013
June 2009
Not Provided
Progression-free survival, defined as ≥ 25% increase in tumor volume or new tumor on MRI [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00904735 on ClinicalTrials.gov Archive Site
  • Survival [ Designated as safety issue: No ]
  • Response rate according to MacDonald criteria [ Designated as safety issue: No ]
  • Toxicity as assessed by NCI CTCAE v. 3.0 [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Hydroxyurea With or Without Imatinib Mesylate in Treating Patients With Recurrent or Progressive Meningioma
IMATINIB Plus Hydroxyurea in the Treatment of Recurrent or Progressive Meningiomas: a Randomized Phase II Study

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.

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.

Interventional
Phase 2
Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Brain and Central Nervous System Tumors
  • Drug: hydroxyurea
    Given orally
  • Drug: imatinib mesylate
    Given orally
  • Experimental: Arm I
    Patients receive oral hydroxyurea twice daily and oral imatinib mesylate once daily in the absence of disease progression or unacceptable toxicity.
    Interventions:
    • Drug: hydroxyurea
    • Drug: imatinib mesylate
  • Experimental: Arm II
    Patients receive oral hydroxyurea twice daily in the absence of disease progression or unacceptable toxicity.
    Intervention: Drug: hydroxyurea
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
76
Not Provided
Not Provided

DISEASE CHARACTERISTICS:

  • Diagnosed with meningioma

    • WHO grade I-III
  • Recurrent or progressive disease after prior surgery and radiotherapy, or radiosurgery
  • Not amenable to further surgery
  • No optic nerve sheet tumor and neurofibromatosis type II
  • No known brain metastasis

PATIENT CHARACTERISTICS:

  • WHO performance status 0-2
  • ANC > 1,500/mm^3
  • Platelet count > 100,000/mm^3
  • Hemoglobin ≥ 9 mg/dL (transfusion allowed)
  • Total bilirubin < 1.5 times upper limit of normal (ULN)
  • SGOT and SGPT < 2.5 times ULN
  • Creatinine < 1.5 times ULN
  • Negative pregnancy test
  • Fertile patients must use effective barrier method contraception during and for up to 3 months after completion of study therapy
  • No second malignancy
  • No known chronic liver disease (i.e., active hepatitis, cirrhosis)
  • No known HIV infection
  • No significant history of non-compliance to medical regimens or inability to grant reliable informed consent

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No concurrent enzyme-inducing anti-epileptic drugs
  • No concurrent therapeutic anticoagulation with warfarin (e.g., Coumadin®)

    • Low-molecular weight heparin (e.g., Lovenox) or heparin allowed
    • Mini-dose Coumadin® (e.g., 1 mg QD) allowed for prophylaxis of central venous catheter thrombosis, at the discretion of the treating physician
  • No concurrent acetaminophen (Efferalgan®, Tachipirina®) allowed during imatinib mesylate administration
  • No other concurrent anticancer agents, including chemotherapy or biological agents
  • No other concurrent investigational drugs
Both
18 Years to 75 Years
No
Italy
 
NCT00904735
SRSI-GICNO-08-002, CDR0000641101, NOVARTIS-SRSI-GICNO-08-002
Not Provided
Not Provided
Istituto Scientifico H. San Raffaele
Not Provided
Study Chair: Alba A. Brandes, MD Ospedale Bellaria
National Cancer Institute (NCI)
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP