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

NCT00904735 | Unknown Phase 2

• 3 other identifiers: SRSI-GICNO-08-002CDR0000641101NOVARTIS-SRSI-GICNO-08-002
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Brain and Central Nervous System Tumors

Keywords

adult grade I meningioma; adult grade II meningioma; adult anaplastic meningioma; adult papillary meningioma; recurrent adult brain tumor

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

• Survival

• Response rate according to MacDonald criteria

• Toxicity as assessed by NCI CTCAE v. 3.0

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive oral hydroxyurea twice daily and oral imatinib mesylate once daily in the absence of disease progression or unacceptable toxicity.

Drug: hydroxyurea; Drug: imatinib mesylate

Arm II

EXPERIMENTAL

Patients receive oral hydroxyurea twice daily in the absence of disease progression or unacceptable toxicity.

Drug: hydroxyurea

Interventions

hydroxyurea DRUG

Given orally

Arm I; Arm II

imatinib mesylate DRUG

Given orally

Arm I

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Istituto Scientifico H. San Raffaele: lead

Study Sites (5)

Ospedale Civile Avellino

Avellino, Italy

RECRUITING

Ospedale Bellaria

Bologna, I-40139, Italy

RECRUITING

Azienda Ospedaliero Careggi

Florence, 50139, Italy

RECRUITING

Istituto Nazionale Neurologico Carlo Besta

Milan, 20133, Italy

RECRUITING

Ospedale Civile di Rovigo

Rovigo, 45100, Italy

RECRUITING

MeSH Terms

Conditions

Central Nervous System Neoplasms; Meningioma; Brain Neoplasms

Interventions

Hydroxyurea; Imatinib Mesylate

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Urea; Amides; Organic Chemicals; Benzamides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Alba A. Brandes, MD

  Ospedale Bellaria

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 19, 2009
• First Posted: May 20, 2009
• Study Start: June 1, 2009
• Last Updated: August 12, 2013

Record last verified: 2009-07

Locations

IT (5)