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
  Purpose

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.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: hydroxyurea
Drug: imatinib mesylate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: IMATINIB Plus Hydroxyurea in the Treatment of Recurrent or Progressive Meningiomas: a Randomized Phase II Study

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival, defined as ≥ 25% increase in tumor volume or new tumor on MRI [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 76
Study Start Date: June 2009
Arms Assigned Interventions
Experimental: Arm I
Patients receive oral hydroxyurea twice daily and oral imatinib mesylate once daily in the absence of disease progression or unacceptable toxicity.
Drug: hydroxyurea
Given orally
Drug: imatinib mesylate
Given orally
Experimental: Arm II
Patients receive oral hydroxyurea twice daily in the absence of disease progression or unacceptable toxicity.
Drug: hydroxyurea
Given orally

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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 ClinicalTrials.gov identifier: NCT00904735

Locations
Italy
Ospedale Civile Avellino Recruiting
Avellino, Italy
Contact: Contact Person    39-0825-203-232      
Ospedale Bellaria Recruiting
Bologna, Italy, I-40139
Contact: Alba A. Brandes, MD    39-51-622-5102    aa.brandes@yahoo.it   
Azienda Ospedaliero Careggi Recruiting
Florence, Italy, 50139
Contact: Contact Person    39-055-427-7111      
Istituto Nazionale Neurologico Carlo Besta Recruiting
Milan, Italy, 20133
Contact: Contact Person    39-02-2394-2341      
Ospedale Civile di Rovigo Recruiting
Rovigo, Italy, 45100
Contact: Contact Person    39-0425-393-016      
Sponsors and Collaborators
Istituto Scientifico H. San Raffaele
Investigators
Study Chair: Alba A. Brandes, MD Ospedale Bellaria
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00904735     History of Changes
Other Study ID Numbers: SRSI-GICNO-08-002, CDR0000641101, NOVARTIS-SRSI-GICNO-08-002
Study First Received: May 19, 2009
Last Updated: August 9, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
adult grade I meningioma
adult grade II meningioma
adult anaplastic meningioma
adult papillary meningioma
recurrent adult brain tumor

Additional relevant MeSH terms:
Meningioma
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Vascular Tissue
Meningeal Neoplasms
Neoplasms by Site
Nervous System Diseases
Imatinib
Hydroxyurea
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antisickling Agents
Hematologic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014