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
Recruitment status was Recruiting
Sponsor:
Istituto Scientifico H. San Raffaele
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00904735
First received: May 19, 2009
Last updated: July 2, 2009
Last verified: July 2009
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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
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: | CDR0000641101, SRSI-GICNO-08-002, NOVARTIS-SRSI-GICNO-08-002 |
| Study First Received: | May 19, 2009 |
| Last Updated: | July 2, 2009 |
| 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 May 19, 2013