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

Brain and Central Nervous System Tumors Clinical Trial

Official title:

IMATINIB Plus Hydroxyurea in the Treatment of Recurrent or Progressive Meningiomas: a Randomized Phase II Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00904735
• Other study ID #: SRSI-GICNO-08-002
• Secondary ID: CDR0000641101NOV
• Status: Recruiting
• Phase: Phase 2
• First received: May 19, 2009
• Last updated: August 9, 2013
• Start date: June 2009

Study information

• Verified date: July 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Meningioma
• Nervous System Neoplasms

Intervention

Drug:
• hydroxyurea
Given orally
• imatinib mesylate
Given orally

Locations

Country	Name	City	State
Italy	Ospedale Civile Avellino	Avellino
Italy	Ospedale Bellaria	Bologna
Italy	Azienda Ospedaliero Careggi	Florence
Italy	Istituto Nazionale Neurologico Carlo Besta	Milan
Italy	Ospedale Civile di Rovigo	Rovigo

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Scientifico H. San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival, defined as = 25% increase in tumor volume or new tumor on MRI			No
Secondary	Survival			No
Secondary	Response rate according to MacDonald criteria			No
Secondary	Toxicity as assessed by NCI CTCAE v. 3.0			Yes