Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2026-01-29 @ 12:25 AM
Study NCT ID:
NCT00087061
Status:
COMPLETED
Last Update Posted:
2013-07-18
First Post:
2004-07-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gimatecan in Treating Patients With Recurrent or Progressive Primary Malignant Glioma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009837', 'term': 'Oligodendroglioma'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D005909', 'term': 'Glioblastoma'}, {'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D018316', 'term': 'Gliosarcoma'}], 'ancestors': [{'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C433984', 'term': 'ST 1481'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-05', 'completionDateStruct': {'date': '2005-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-17', 'studyFirstSubmitDate': '2004-07-08', 'studyFirstSubmitQcDate': '2004-07-09', 'lastUpdatePostDateStruct': {'date': '2013-07-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-07-12', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['adult anaplastic oligodendroglioma', 'recurrent adult brain tumor', 'adult glioblastoma', 'adult anaplastic astrocytoma', 'adult giant cell glioblastoma', 'adult gliosarcoma'], 'conditions': ['Brain and Central Nervous System Tumors']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as gimatecan, work in different ways to stop tumor cells from dividing so they stop growing or die.\n\nPURPOSE: This phase I/II trial is studying the side effects and best dose of gimatecan in treating patients with recurrent or progressive primary malignant glioma.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the maximum tolerated dose (MTD) of gimatecan in patients with recurrent or progressive primary malignant glioma treated with or without concurrent enzyme-inducing anticonvulsant drugs.\n* Determine whether this drug has sufficient activity to warrant further development in these patients. (phase II)\n\nSecondary\n\n* Determine the qualitative and quantitative toxic effects of this drug in these patients.\n* Determine the pharmacokinetic behaviors of this drug in these patients.\n* Correlate the principal toxic effects with the pertinent pharmacokinetic parameters of this drug in these patients.\n* Determine the antitumor activity of this drug in these patients.\n\nOUTLINE: This is an open-label, dose-escalation, multicenter study. Patients are stratified according to the concurrent use of enzyme-inducing anticonvulsant drugs (yes vs no).\n\n* Phase I: Patients receive oral gimatecan once daily on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\n\nCohorts of 3-6 patients receive escalating doses of gimatecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.\n\n* Phase II: Patients receive gimatecan as in phase I at the MTD. Patients are followed for at least 1 month and then every 2 months thereafter.\n\nPROJECTED ACCRUAL: Approximately 30-83 patients (30-42 for phase I \\[15-21 per stratum\\] and 21-41 for phase II) will be accrued for this study within 24 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed malignant glioma (glioblastoma multiforme, anaplastic astrocytoma, or anaplastic oligodendroglioma)\n\n * Recurrent or progressive primary CNS neoplasm by contrast-enhanced MRI\n* Tumor progression after prior surgery, radiotherapy, or chemotherapy\n* Measurable or evaluable disease\n* Failed prior standard curative or palliative therapy (phase I only)\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* Karnofsky 60-100%\n\nLife expectancy\n\n* At least 3 months\n\nHematopoietic\n\n* Absolute neutrophil count ≥ 2,000/mm\\^3\n* Platelet count ≥ 100,000/mm\\^3\n\nHepatic\n\n* SGPT and SGOT ≤ 1.5 times upper limit of normal (ULN) (3 times ULN if liver metastases are present)\n* Alkaline phosphatase ≤ 2.5 times ULN (5 times ULN if liver metastases are present)\n* Bilirubin normal\n\nRenal\n\n* Creatinine ≤ 1.5 times ULN\n\nCardiovascular\n\n* No myocardial infarction with the past year\n* No heart failure (including cardiac insufficiency controlled by digitalis and diuretics)\n* No irreversible arrhythmias requiring permanent medication\n* No uncontrolled hypertension\n\nGastrointestinal\n\n* No gastrointestinal dysfunction that would alter absorption or motility, such as any of the following:\n\n * Active peptic ulcer\n * Inflammatory bowel disease\n * Known intolerance to lactose\n * Malabsorption syndromes\n * Intestinal sub-occlusion\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective barrier contraception\n* No active infection\n* No mentally incapacitated patients\n* No other concurrent severe disease that would preclude study participation\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* No concurrent immunotherapy\n\nChemotherapy\n\n* See Disease Characteristics\n* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)\n* No more than 1 prior chemotherapy regimen\n* No other concurrent chemotherapy\n\nEndocrine therapy\n\n* Concurrent corticosteroids allowed if dose stable for the past 2 weeks\n* No concurrent hormonal therapy\n\nRadiotherapy\n\n* See Disease Characteristics\n* At least 4 weeks since prior radiotherapy\n* No concurrent radiotherapy\n\nSurgery\n\n* See Disease Characteristics\n* At least 3 weeks since prior surgical resection\n* No prior gastrointestinal surgery that would affect drug absorption\n\nOther\n\n* More than 4 weeks since prior participation in any other investigational drug study\n* More than 72 hours since prior systemic antibiotics\n* No concurrent H2 antagonists, antacids, or proton pump inhibitors\n\n * If any of these therapies are necessary, ≥ 3 hours must elapse after gimatecan administration\n* No other concurrent anticancer therapy\n* No other concurrent investigational drugs\n* No other concurrent immunosuppressive agents'}, 'identificationModule': {'nctId': 'NCT00087061', 'briefTitle': 'Gimatecan in Treating Patients With Recurrent or Progressive Primary Malignant Glioma', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Oral ST1481 in Adults With Malignant Glioma: A Phase I-II Clinical Trial', 'orgStudyIdInfo': {'id': 'SIGMATAU-ST-01-402'}, 'secondaryIdInfos': [{'id': 'UCLA-0403029-01'}, {'id': 'SIGMATAU-ST-01-402'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'gimatecan', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Jonsson Comprehensive Cancer Center at UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Timothy F. Cloughesy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jonsson Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jonsson Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}