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

August 9, 2013 updated by: Istituto Scientifico H. San Raffaele

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

76

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Avellino, Italy
        • Recruiting
        • Ospedale Civile Avellino
        • Contact:
          • Contact Person
          • Phone Number: 39-0825-203-232
      • Bologna, Italy, I-40139
        • Recruiting
        • Ospedale Bellaria
        • Contact:
      • Florence, Italy, 50139
        • Recruiting
        • Azienda Ospedaliero Careggi
        • Contact:
          • Contact Person
          • Phone Number: 39-055-427-7111
      • Milan, Italy, 20133
        • Recruiting
        • Istituto Nazionale Neurologico Carlo Besta
        • Contact:
          • Contact Person
          • Phone Number: 39-02-2394-2341
      • Rovigo, Italy, 45100
        • Recruiting
        • Ospedale Civile di Rovigo
        • Contact:
          • Contact Person
          • Phone Number: 39-0425-393-016

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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: imatinib mesylate
Given orally
Drug: hydroxyurea
Given orally
Experimental: Arm II
Patients receive oral hydroxyurea twice daily in the absence of disease progression or unacceptable toxicity.
Drug: hydroxyurea
Given orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Progression-free survival, defined as ≥ 25% increase in tumor volume or new tumor on MRI

Secondary Outcome Measures

Outcome Measure
Survival
Response rate according to MacDonald criteria
Toxicity as assessed by NCI CTCAE v. 3.0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Scientifico H. San Raffaele

Investigators

  • Study Chair: Alba A. Brandes, MD, Ospedale Bellaria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Study Registration Dates

First Submitted

May 19, 2009

First Submitted That Met QC Criteria

May 19, 2009

First Posted (Estimate)

May 20, 2009

Study Record Updates

Last Update Posted (Estimate)

August 12, 2013

Last Update Submitted That Met QC Criteria

August 9, 2013

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SRSI-GICNO-08-002
  • CDR0000641101 (Registry Identifier: PDQ (Physician Data Query))
  • NOVARTIS-SRSI-GICNO-08-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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