Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2025-12-25 @ 4:24 PM
Study NCT ID:
NCT00311857
Status:
UNKNOWN
Last Update Posted:
2006-09-08
First Post:
2006-04-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety Study of Cetuximab, Radiotherapy and Temozolomide in Primary Glioblastoma Multiforme(GERT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005909', 'term': 'Glioblastoma'}], 'ancestors': [{'id': 'D001254', 'term': 'Astrocytoma'}, {'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': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068818', 'term': 'Cetuximab'}, {'id': 'D000077204', 'term': 'Temozolomide'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'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'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 46}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-09', 'lastUpdateSubmitDate': '2006-09-07', 'studyFirstSubmitDate': '2006-04-05', 'studyFirstSubmitQcDate': '2006-04-05', 'lastUpdatePostDateStruct': {'date': '2006-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-04-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Toxicity'}], 'secondaryOutcomes': [{'measure': 'Overall survival'}]}, 'conditionsModule': {'keywords': ['Cetuximab'], 'conditions': ['Glioblastoma Multiforme']}, 'descriptionModule': {'briefSummary': "GERT is a one-armed single-center phase I/II trial. In a first step, dose-escalation of TMZ from 50 mg/m2 to 75mg/m2 together with radiotherapy and cetuximab will be performed. Should safety be proven, the phase II trial will be initiated with the standard dose of 75mg/m2 of TMZ. Cetuximab will be applied in the standard application dose of 400mg/m2 in week 1, thereafter at a dose of 250mg/m2 weekly. A total of 46 patients will be included into this phase I/II trial.\n\nPrimary endpoints are feasibility and toxicity, secondary endpoints are overall and progression-free survival. An interim analysis will be performed after inclusion of 15 patients into the main study. Patients' enrolment will be performed over a period of 2 years. The observation time will end 2 years after inclusion of the last patient."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>= 18 and \\< 70 years of age\n* Karnofsky Performance Score \\>= 60\n* histologically confirmed supratentorial GBM\n* interval between primary diagnosis and registration for the study \\< 4 weeks\n* patients will be included according to the incidental gender distribution for patients with GBM of ♀/♂ 2:3\n* adequate blood values (not older than 14 days prior to initiation of RCHT)\n* neutrophil count (ANC) ≥1500/mm3 or white blood cells (WBC) ≥2000/mm3\n* platelets ≥100.000/mm3\n* hemoglobin ≥10g/dL\n* BUN \\<1.5 times the upper range\n* Total and direct bilirubin \\<1.5times the upper laboratory limit\n* Adequate liver enzymes \\<3 times the upper laboratory limit\n* Life expectancy \\>12 weeks\n* Written informed consent\n\nExclusion Criteria:\n\n* refusal of the patients to take part in the study\n* previous radiotherapy of the brain or chemotherapy with DTIC or TMZ\n* known allergy against extrinsical proteins\n* previous chemotherapy or therapy with an EGFR-inhibitor\n* Previous antibody therapy\n* Patients who have not yet recovered from acute toxicities of prior therapies\n* Acute infections requiring systemic application of antibiotics\n* Frequent vomiting or a medical condition preventing the oral application of TMZ\n* Clinically active kidney- liver or cardiac disease\n* Known carcinoma \\< 5 years ago (excluding Carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin)\n* HIV\n* Pregnant or lactating women\n* Participation in another clinical study'}, 'identificationModule': {'nctId': 'NCT00311857', 'briefTitle': 'Safety Study of Cetuximab, Radiotherapy and Temozolomide in Primary Glioblastoma Multiforme(GERT)', 'organization': {'class': 'OTHER', 'fullName': 'Heidelberg University'}, 'officialTitle': 'Treatment of Primary Glioblastoma Multiforme With Cetuximab, Radiotherapy and Temozolomide (GERT) - Phase I/II Trial', 'orgStudyIdInfo': {'id': 'Eudract-2005-003911-63'}, 'secondaryIdInfos': [{'id': 'PEI 119/01'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Cetuximab', 'type': 'DRUG'}, {'name': 'Temozolomide', 'type': 'DRUG'}, {'name': 'Radiation therapy', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '69120', 'city': 'Heidelberg', 'state': 'Baden-Wurttemberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Daniela Schulz-Ertner, MD', 'role': 'CONTACT', 'email': 'Daniela.Ertner@med.uni-heidelberg.de', 'phone': '+49-6221-56', 'phoneExt': '8201'}, {'name': 'Stephanie E Combs, MD', 'role': 'CONTACT', 'email': 'Stephanie.Combs@med.uni-heidelberg.de', 'phone': '+49-6221-56', 'phoneExt': '8201'}, {'name': 'Daniela Schulz-Ertner, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Stephanie E Combs, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'centralContacts': [{'name': 'Daniela Schulz-Ertner, MD', 'role': 'CONTACT', 'email': 'Daniela.Ertner@med.uni-heidelberg.de', 'phone': '+49-6221-56', 'phoneExt': '8201'}, {'name': 'Stephanie E Combs, MD', 'role': 'CONTACT', 'email': 'Stephanie.Combs@med.uni-heidelberg.de', 'phone': '+49-6221-56', 'phoneExt': '8201'}], 'overallOfficials': [{'name': 'Daniela Schulz-Ertner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heidelberg University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heidelberg University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck KGaA, Darmstadt, Germany', 'class': 'INDUSTRY'}]}}}