Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2026-03-01 @ 5:17 PM
Study NCT ID:
NCT00904735
Status:
UNKNOWN
Last Update Posted:
2013-08-12
First Post:
2009-05-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hydroxyurea With or Without Imatinib Mesylate in Treating Patients With Recurrent or Progressive Meningioma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D008579', 'term': 'Meningioma'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009383', 'term': 'Neoplasms, Vascular Tissue'}, {'id': 'D008577', 'term': 'Meningeal Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006918', 'term': 'Hydroxyurea'}, {'id': 'D000068877', 'term': 'Imatinib Mesylate'}], 'ancestors': [{'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 76}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'lastUpdateSubmitDate': '2013-08-09', 'studyFirstSubmitDate': '2009-05-19', 'studyFirstSubmitQcDate': '2009-05-19', 'lastUpdatePostDateStruct': {'date': '2013-08-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival, defined as ≥ 25% increase in tumor volume or new tumor on MRI'}], 'secondaryOutcomes': [{'measure': 'Survival'}, {'measure': 'Response rate according to MacDonald criteria'}, {'measure': 'Toxicity as assessed by NCI CTCAE v. 3.0'}]}, 'conditionsModule': {'keywords': ['adult grade I meningioma', 'adult grade II meningioma', 'adult anaplastic meningioma', 'adult papillary meningioma', 'recurrent adult brain tumor'], 'conditions': ['Brain and Central Nervous System Tumors']}, 'descriptionModule': {'briefSummary': '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.\n\nPURPOSE: 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.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Assess the progression-free survival of patients with recurrent or progressive meningiomas treated with hydroxyurea with vs without imatinib mesylate after surgery and radiotherapy.\n\nSecondary\n\n* Determine the overall survival, and response rate of patients treated with this regimen.\n* Determine the toxicity of this regimen in these patients.\n\nOUTLINE: 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.\n\n* Arm I: Patients receive oral hydroxyurea twice daily and oral imatinib mesylate once daily in the absence of disease progression or unacceptable toxicity.\n* Arm II: Patients receive oral hydroxyurea twice daily in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study therapy, patients are followed for up to 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosed with meningioma\n\n * WHO grade I-III\n* Recurrent or progressive disease after prior surgery and radiotherapy, or radiosurgery\n* Not amenable to further surgery\n* No optic nerve sheet tumor and neurofibromatosis type II\n* No known brain metastasis\n\nPATIENT CHARACTERISTICS:\n\n* WHO performance status 0-2\n* ANC \\> 1,500/mm\\^3\n* Platelet count \\> 100,000/mm\\^3\n* Hemoglobin ≥ 9 mg/dL (transfusion allowed)\n* Total bilirubin \\< 1.5 times upper limit of normal (ULN)\n* SGOT and SGPT \\< 2.5 times ULN\n* Creatinine \\< 1.5 times ULN\n* Negative pregnancy test\n* Fertile patients must use effective barrier method contraception during and for up to 3 months after completion of study therapy\n* No second malignancy\n* No known chronic liver disease (i.e., active hepatitis, cirrhosis)\n* No known HIV infection\n* No significant history of non-compliance to medical regimens or inability to grant reliable informed consent\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* No concurrent enzyme-inducing anti-epileptic drugs\n* No concurrent therapeutic anticoagulation with warfarin (e.g., Coumadin®)\n\n * Low-molecular weight heparin (e.g., Lovenox) or heparin allowed\n * Mini-dose Coumadin® (e.g., 1 mg QD) allowed for prophylaxis of central venous catheter thrombosis, at the discretion of the treating physician\n* No concurrent acetaminophen (Efferalgan®, Tachipirina®) allowed during imatinib mesylate administration\n* No other concurrent anticancer agents, including chemotherapy or biological agents\n* No other concurrent investigational drugs'}, 'identificationModule': {'nctId': 'NCT00904735', 'briefTitle': 'Hydroxyurea With or Without Imatinib Mesylate in Treating Patients With Recurrent or Progressive Meningioma', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'IMATINIB Plus Hydroxyurea in the Treatment of Recurrent or Progressive Meningiomas: a Randomized Phase II Study', 'orgStudyIdInfo': {'id': 'SRSI-GICNO-08-002'}, 'secondaryIdInfos': [{'id': 'CDR0000641101', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'NOVARTIS-SRSI-GICNO-08-002'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I', 'description': 'Patients receive oral hydroxyurea twice daily and oral imatinib mesylate once daily in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: hydroxyurea', 'Drug: imatinib mesylate']}, {'type': 'EXPERIMENTAL', 'label': 'Arm II', 'description': 'Patients receive oral hydroxyurea twice daily in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: hydroxyurea']}], 'interventions': [{'name': 'hydroxyurea', 'type': 'DRUG', 'description': 'Given orally', 'armGroupLabels': ['Arm I', 'Arm II']}, {'name': 'imatinib mesylate', 'type': 'DRUG', 'description': 'Given orally', 'armGroupLabels': ['Arm I']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Avellino', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '39-0825-203-232'}], 'facility': 'Ospedale Civile Avellino', 'geoPoint': {'lat': 40.91494, 'lon': 14.79103}}, {'zip': 'I-40139', 'city': 'Bologna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alba A. Brandes, MD', 'role': 'CONTACT', 'email': 'aa.brandes@yahoo.it', 'phone': '39-51-622-5102'}], 'facility': 'Ospedale Bellaria', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '50139', 'city': 'Florence', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '39-055-427-7111'}], 'facility': 'Azienda Ospedaliero Careggi', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '20133', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '39-02-2394-2341'}], 'facility': 'Istituto Nazionale Neurologico Carlo Besta', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '45100', 'city': 'Rovigo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '39-0425-393-016'}], 'facility': 'Ospedale Civile di Rovigo', 'geoPoint': {'lat': 45.06982, 'lon': 11.79022}}], 'overallOfficials': [{'name': 'Alba A. Brandes, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ospedale Bellaria'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Scientifico H. San Raffaele', 'class': 'OTHER'}}}}