Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-29 @ 11:18 AM
Study NCT ID:
NCT00003304
Status:
COMPLETED
Last Update Posted:
2012-03-06
First Post:
1999-11-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Temozolomide in Treating Patients With Recurrent Oligodendroglial Tumors
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'}], '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'}]}, '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': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'lastUpdateSubmitDate': '2012-03-05', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2004-08-25', 'lastUpdatePostDateStruct': {'date': '2012-03-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2000-03', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['adult oligodendroglioma'], 'conditions': ['Brain and Central Nervous System Tumors']}, 'referencesModule': {'references': [{'pmid': '16914310', 'type': 'BACKGROUND', 'citation': 'Kouwenhoven MC, Kros JM, French PJ, Biemond-ter Stege EM, Graveland WJ, Taphoorn MJ, Brandes AA, van den Bent MJ. 1p/19q loss within oligodendroglioma is predictive for response to first line temozolomide but not to salvage treatment. Eur J Cancer. 2006 Oct;42(15):2499-503. doi: 10.1016/j.ejca.2006.05.021. Epub 2006 Aug 17.'}, {'pmid': '12649108', 'type': 'RESULT', 'citation': 'van den Bent MJ, Chinot O, Boogerd W, Bravo Marques J, Taphoorn MJ, Kros JM, van der Rijt CC, Vecht CJ, De Beule N, Baron B. Second-line chemotherapy with temozolomide in recurrent oligodendroglioma after PCV (procarbazine, lomustine and vincristine) chemotherapy: EORTC Brain Tumor Group phase II study 26972. Ann Oncol. 2003 Apr;14(4):599-602. doi: 10.1093/annonc/mdg157.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.\n\nPURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients with recurrent oligodendroglial tumors following combination chemotherapy.', 'detailedDescription': 'OBJECTIVES: I. Determine the response rate and duration of response in oligodendroglial tumors to temozolomide treatment in patients with progressive disease during or after procarbazine/lomustine/vincristine (PCV) chemotherapy. II. Determine the feasibility and toxicity of temozolomide chemotherapy following PVC chemotherapy in these patients.\n\nOUTLINE: This is an open label, multicenter trial. Temozolomide is administered orally on days 1-5 of each 4-week course; treatment continues for a maximum of 12 courses. Patients are followed every 2 months for the first 6 months and then every 3 months thereafter.\n\nPROJECTED ACCRUAL: A total of 16-29 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS: Histologically proven oligodendroglioma or oligoastrocytoma (with at least 25% oligodendroglial elements) Recurrent or progressive disease following both radiotherapy and procarbazine/lomustine/vincristine chemotherapy (or other nitrosoureas-based chemotherapy) Contrast enhancing, measurable disease (at least one lesion measuring at least 1 cm) by CT or MRI required Within 2 weeks prior to study treatment Within 3 days following concurrent surgery for the recurrence Steroid doses stable or decreasing for at least 2 weeks prior to scan No extracranial disease\n\nPATIENT CHARACTERISTICS: Age: 18-69 Performance status: WHO 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.25 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2 times ULN AST/ALT no greater than 2 times ULN Renal: Creatinine no greater than 1.25 times ULN Creatinine clearance at least 60 mL/min Other: Not pregnant or lactating Effective contraception required of fertile women No diseases interfering with follow-up\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No more than one prior chemotherapy regimen At least 4 weeks since prior chemotherapy Prior nitrosourea required At least 6 weeks since nitrosourea Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics More than 3 months since radiotherapy Surgery: Not specified Other: No concurrent treatment with other investigational agents or other antitumor agents'}, 'identificationModule': {'nctId': 'NCT00003304', 'briefTitle': 'Temozolomide in Treating Patients With Recurrent Oligodendroglial Tumors', 'organization': {'class': 'NETWORK', 'fullName': 'European Organisation for Research and Treatment of Cancer - EORTC'}, 'officialTitle': 'Second Line Chemotherapy With Temozolomide in Recurrent Oligodendroglial Tumors After PCV-Chemotherapy', 'orgStudyIdInfo': {'id': 'EORTC-26972'}, 'secondaryIdInfos': [{'id': 'EORTC-26972'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'temozolomide', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'A-1100', 'city': 'Vienna (Wien)', 'country': 'Austria', 'facility': 'Kaiser Franz Josef Hospital', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Hopital Universitaire Erasme', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': 'FIN-0-0029', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Helsinki University Central Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': 'FIN-2-0521', 'city': 'Turku', 'country': 'Finland', 'facility': 'Turku University Central Hospital', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Institut Bergonie', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '14076', 'city': 'Caen', 'country': 'France', 'facility': 'Centre Regional Francois Baclesse', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '68024', 'city': 'Colmar', 'country': 'France', 'facility': 'Hopital Louis Pasteur', 'geoPoint': {'lat': 48.08078, 'lon': 7.35584}}, {'zip': '94275', 'city': 'Le Kremlin-Bicêtre', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Bicetre', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'zip': '69373', 'city': 'Lyon', 'country': 'France', 'facility': 'Centre Leon Berard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13385', 'city': 'Marseille', 'country': 'France', 'facility': 'CHU de la Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '54035', 'city': 'Nancy', 'country': 'France', 'facility': 'CHU de Nancy - Hopital Neurologique', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '44805', 'city': 'Nantes-Saint Herblain', 'country': 'France', 'facility': 'CRLCC Nantes - Atlantique'}, {'zip': '06002', 'city': 'Nice', 'country': 'France', 'facility': 'Hopital Pasteur', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '06189', 'city': 'Nice', 'country': 'France', 'facility': 'Centre Antoine Lacassagne', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '30000', 'city': 'Nîmes', 'country': 'France', 'facility': 'C.H.R. de Nimes - Hopital Caremeau', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '75651', 'city': 'Paris', 'country': 'France', 'facility': 'CHU Pitie-Salpetriere', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': 'F-94805', 'city': 'Villejuif', 'country': 'France', 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': 'D-12200', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Universitaetsklinikum Benjamin Franklin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': 'D-30559', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Neurologische Klinik der Henriettenstiftung', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': 'D-72076', 'city': 'Tübingen', 'country': 'Germany', 'facility': 'Universitaetsklinikum Tuebingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'zip': '1145', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'National Institute of Neurosurgery', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '35128', 'city': 'Padova (Padua)', 'country': 'Italy', 'facility': 'Azienda Ospedaliera di Padova', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': '10126', 'city': 'Torino', 'country': 'Italy', 'facility': 'Universita Degli Studi di Torino', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'zip': '1007 MB', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Academisch Ziekenhuis der Vrije Universiteit', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '1066 CX', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Antoni van Leeuwenhoekhuis', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '9713 EZ', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'Academisch Ziekenhuis Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': '6202 AZ', 'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Academisch Ziekenhuis Maastricht', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'zip': '6500 HB', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'St. Radboud University Hospital', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '3075 EA', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Rotterdam Cancer Institute', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '5022 GC', 'city': 'Tilburg', 'country': 'Netherlands', 'facility': 'St. Elisabeth Ziekenhuis', 'geoPoint': {'lat': 51.55551, 'lon': 5.0913}}, {'zip': '5042 SB', 'city': 'Tilburg', 'country': 'Netherlands', 'facility': 'Dr. Bernard Verbeeten Instituut', 'geoPoint': {'lat': 51.55551, 'lon': 5.0913}}, {'zip': '3508 GA', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'Academisch Ziekenhuis Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'zip': '1093', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Instituto Portugues de Oncologia de Francisco Gentil', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': 'S-901 85', 'city': 'Umeå', 'country': 'Sweden', 'facility': 'Umea Universitet', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}, {'zip': 'EH4 9NQ', 'city': 'Edinburgh', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Western General Hospital', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'zip': 'G11 6NT', 'city': 'Glasgow', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Beatson Oncology Centre', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}], 'overallOfficials': [{'name': 'Martin J. van Den Bent, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Daniel Den Hoed Cancer Center at Erasmus Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Organisation for Research and Treatment of Cancer - EORTC', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}