Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2026-02-20 @ 12:29 PM
Study NCT ID:
NCT02263105
Status:
COMPLETED
Last Update Posted:
2018-07-17
First Post:
2014-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Tolerability of Cisplatin Plus Alternating Weekly Temozolomide in Recurrent High-grade Gliomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-14', 'studyFirstSubmitDate': '2014-09-28', 'studyFirstSubmitQcDate': '2014-10-08', 'lastUpdatePostDateStruct': {'date': '2018-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'progression free survival (PFS)', 'timeFrame': 'at 6 months'}], 'secondaryOutcomes': [{'measure': 'overall survival(OS)', 'timeFrame': 'at 1 year and 2 years'}]}, 'conditionsModule': {'keywords': ['recurrent high-grade gliomas', 'cisplatin (CDDP)', 'temozolomide (TMZ)'], 'conditions': ['High-grade Gliomas']}, 'descriptionModule': {'briefSummary': 'Currently, the prognosis of recurrent high-grade gliomas is still dismal with no standard treatment protocol established. Cisplatin (CDDP), recommended by National Comprehensive Cancer Network (NCCN) as a chemotherapeutic agent in salvage treatment for recurrent high-grade gliomas, was shown to reduce O6-alkylguanine DNA-alkyl transferase (AGAT) activity and potentially capable of enhancing the antitumor effects of temozolomide (TMZ). Compared to the standard 5-day TMZ regimen, alternating weekly regimen that deliver more prolonged exposure of TMZ may lead to higher cumulative doses, and may deplete more O6-methylguanine DNA methyltransferase (MGMT), thus reducing the resistance of tumor cells to TMZ.\n\nThe investigators therefore initiate a single-arm Phase II study to evaluate the efficacy and tolerability of CDDP plus alternating weekly TMZ regimen in patients with recurrent high-grade gliomas.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological diagnosis of primary tumor as high-grade gliomas (WHO III or IV)\n* All patients should complete radiation therapy for primary gliomas.\n* MRI showed unequivocal evidence of tumor recurrence or progression.\n* The time to be enrolled should be more than 90 days after the radiation therapy.\n* Written informed consent\n* Eastern Cooperative Oncology Group(ECOG) score: 0-2\n* The patients with recurrent gliomas were treated without dose-dense TMZ therapy before enrollment.\n* Surgical interventions for recurrent gliomas are permitted and patients with no residual tumor are permitted\n\nExclusion Criteria:\n\n* Abnormal function of liver or renal (value more than 1.5 fold normal upper limit)\n* Blood routing: Hb \\< 90g/L, absolute neutrophil count≤1.5\\*10\\^9/L, platelet \\< 100\\*10\\^9/L\n* Pregnant or lactating women\n* Allergic to administered drugs\n* Radiation therapy in the previous 90 days before enrollment\n* The patients with recurrent gliomas were treated with dose-dense TMZ therapy before enrollment.\n* Acute infection in need of antibiotics intravenously\n* Participation in other clinical trials in the 90 days before enrollment'}, 'identificationModule': {'nctId': 'NCT02263105', 'briefTitle': 'Efficacy and Tolerability of Cisplatin Plus Alternating Weekly Temozolomide in Recurrent High-grade Gliomas', 'organization': {'class': 'OTHER', 'fullName': 'Huashan Hospital'}, 'officialTitle': 'Efficacy and Tolerability of Cisplatin Plus Alternating Weekly Temozolomide in Recurrent High-grade Gliomas: A Single-arm Prospective Phase II Clinical Study', 'orgStudyIdInfo': {'id': 'CAT001'}, 'secondaryIdInfos': [{'id': 'Huashan H', 'type': 'OTHER', 'domain': 'Huashan H'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CDDP plus Temozolomide', 'description': 'Patients were treated with CDDP and TMZ. CDDP was administered iv from Day 1 to 3 with everyday dose of 30mg. TMZ was orally administered from Day 1 to 7 and Day 15 to 21, with everyday dose of 125mg/m2 (Level 2). The period of one chemotherapy cycle is 28 days. TMZ dose levels were listed in Table 1.\n\nTable 1 TMZ dose levels Dose levels Daily TMZ dose( mg/m2/d ) TMZ dose per cycle(mg/m2)\n\n1. 150 2100\n2. 125 1750\n3. 100 1400\n4. 75 1050', 'interventionNames': ['Drug: CDDP', 'Drug: Temozolomide']}], 'interventions': [{'name': 'CDDP', 'type': 'DRUG', 'armGroupLabels': ['CDDP plus Temozolomide']}, {'name': 'Temozolomide', 'type': 'DRUG', 'description': 'If hematologic and nonhematologic toxicity assessed according to the Common Terminology Criteria for Adverse Events (CTCAE; version 4.0) from the previous cycle had been grade 0 or 1, then TMZ dose escalation to was allowed to the maximum of 150 mg/m2. If grade 4 hematologic toxicity or grade 3 nonhematologic toxicity had occurred, then TMZ dose was reduced in 25 mg/m2 steps. If grade 4 nonhematologic toxicity occurred, patient treatment was halted. If grade 4 hematologic toxicity or grade 3 nonhematologic toxicity continued when TMZ dose was in the minimum of 75 mg/m2, patient treatment was halted.', 'armGroupLabels': ['CDDP plus Temozolomide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200040', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Huashan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Zhiyong Qin, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Huashan Hospital'}, {'name': 'Ying Mao, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Huashan Hospital'}, {'name': 'Yu Yao, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Huashan Hospital'}, {'name': 'ZhenYu Zhang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Huashan Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huashan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Zhang Zhenyu', 'investigatorAffiliation': 'Huashan Hospital'}}}}