Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT00005812
Status:
TERMINATED
Last Update Posted:
2013-05-14
First Post:
2000-06-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Temozolomide in Treating Patients With Leptomeningeal Metastases From a Solid Tumor or Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D055756', 'term': 'Meningeal Carcinomatosis'}], 'ancestors': [{'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D008577', 'term': 'Meningeal Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077204', 'term': 'Temozolomide'}], 'ancestors': [{'id': 'D003606', 'term': 'Dacarbazine'}, {'id': 'D014226', 'term': 'Triazenes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'whyStopped': 'No objective response documented, protocol terminated after 12 patients.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2000-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2004-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-13', 'studyFirstSubmitDate': '2000-06-02', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-05-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response', 'timeFrame': 'Every 6 weeks', 'description': 'Response will be assessed clinically, cytologically, and radiographically.'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics', 'timeFrame': 'Every 6 weeks', 'description': 'Drug levels in cerebrospinal fluid assessed every 6 weeks'}, {'measure': 'Survival', 'timeFrame': 'every 6 weeks'}, {'measure': 'Quality of Life', 'timeFrame': 'Baseline, weekly during cycle 1, before each additional cycle', 'description': 'FACT-Br'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['leptomeningeal metastases', 'temozolomide'], 'conditions': ['Brain Tumors', 'Central Nervous System Tumors', 'Leptomeningeal Metastases']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Davis TH, Fadul CE, Glantz MJ, et al.: Pilot phase II trial of temozolomide for leptomeningeal metastases: preliminary report. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-460, 2003. ISBN 1932312021'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.\n\nPURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have leptomeningeal metastases from a solid tumor or lymphoma.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the objective response rate, survival time, and quality of life of patients with leptomeningeal metastases from a solid tumor or lymphoma when treated with oral temozolomide.\n* Determine adverse events related to this regimen in this patient population.\n* Measure temozolomide concentrations in CSF and serum and correlate with appropriate pharmacodynamic parameters (e.g., response) in these patients.\n\nOUTLINE: Patients receive oral temozolomide daily for 6 weeks. Courses repeat every 10 weeks in the absence of unacceptable toxicity or disease progression.\n\nPatients with a complete response (CR) receive 2 additional courses after achieving CR. Patients with a CR except for residual radiographic abnormalities that persist unchanged for 2 full courses continue for 4 courses past best response.\n\nQuality of life is assessed at baseline, weekly for the first 4 weeks of therapy, and then monthly thereafter.\n\nPROJECTED ACCRUAL: A total of 14-24 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* Documented leptomeningeal metastases\n* Carcinomatous meningitis that is previously untreated or failed prior therapy OR\n* Lymphomatous meningitis\n* Systemic disease that is responding or stable on current therapy not eligible if discontinuing therapy would be deleterious\n* Age 18 and over\n* Karnofsky Performance Status 60-100%\n* Life expectancy of at least 6 weeks\n* Absolute neutrophil count greater than 1,500/μL\n* Platelet count greater than 100,000/μL\n* Creatinine no greater than 2.0 mg/dL\n* No congestive heart failure\n* No unstable angina\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No contraindication to diagnostic sampling of CSF via lumbar puncture or reservoir\n* No medical conditions that would interfere with absorption of oral medication (e.g., malabsorption, obstruction, or frequent vomiting)\n* No uncontrolled infection\n* Prior neuroaxis chemotherapy (lumbar puncture, reservoir, or systemic) allowed\n* No other concurrent chemotherapy for other sites of disease\n* No prior radiotherapy to areas of measurable meningeal disease unless there is clear radiographic progression in these areas\n* No prior radiotherapy to greater than 30% of bone marrow\n* Prior radiotherapy to the neuroaxis allowed\n* No concurrent radiotherapy for other sites of disease or for progressive disease\n* Recovered from any prior recent therapy'}, 'identificationModule': {'nctId': 'NCT00005812', 'briefTitle': 'Temozolomide in Treating Patients With Leptomeningeal Metastases From a Solid Tumor or Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Dartmouth-Hitchcock Medical Center'}, 'officialTitle': 'A Pilot Phase II Trial of Temozolomide in Leptomeningeal Metastases', 'orgStudyIdInfo': {'id': 'D9812'}, 'secondaryIdInfos': [{'id': 'DMS-9812'}, {'id': 'NCI-G00-1782'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Temozolomide', 'description': 'Oral temozolomide 75 mg/m2/day for 6 weeks, followed by 4 week break. Cycles will continue until:\n\n* disease progression\n* intolerable toxicity\n* complete response - 2 full additional cycles\n* if response is complete except for residual radiographic abnormalities that persist unchanged for 2 full cycles: continue for 4 cycles past best response.', 'interventionNames': ['Drug: temozolomide']}], 'interventions': [{'name': 'temozolomide', 'type': 'DRUG', 'armGroupLabels': ['Temozolomide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03756-0002', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Norris Cotton Cancer Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}], 'overallOfficials': [{'name': 'Thomas H. Davis, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Norris Cotton Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dartmouth-Hitchcock Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}