Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2026-03-02 @ 6:43 PM
Study NCT ID:
NCT00204633
Status:
COMPLETED
Last Update Posted:
2009-02-16
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Darbepoetin Alfa in Patients With "Poor Prognosis" Germ Cell Tumor Treated With High-Dose Chemotherapy (HD-VIP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004407', 'term': 'Dysgerminoma'}], 'ancestors': [{'id': 'D018237', 'term': 'Germinoma'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068256', 'term': 'Darbepoetin alfa'}], 'ancestors': [{'id': 'D004921', 'term': 'Erythropoietin'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-02-13', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2009-02-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'frequency of transfusions (reduction from 90% to 65%)'}], 'secondaryOutcomes': [{'measure': 'proportion of patients with no transfusions'}, {'measure': 'developing of hemoglobin levels'}, {'measure': 'objective remission rate'}, {'measure': 'progression-free- and overall-survival (pfs, os)'}, {'measure': 'quality of life'}]}, 'conditionsModule': {'conditions': ['Dysgerminoma']}, 'descriptionModule': {'briefSummary': 'The aim is to determine the frequency of RBC transfusion in patients with metastatic "poor prognosis" germ cell tumor during high-dose chemotherapy (HD-VIP, level 6) with or without Darbepoetin alfa'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Poor prognosis" according IGCCCG-criteria:\n* Primary mediastinal tumor\n* Gonadal/retroperitoneal germ cell tumor with visceral metastases except of lung\n* Poor marker: AFP \\> 10.000 ng/ml or beta-HCG \\> 10.000 ng/ml (50.000 IU/l) andd LDH \\>10 x upper normal limit\n* No previous chemotherapy\n* Age \\> 18 years\n* Performance-Status: WHO =\\< 2\n* Written informed consent\n* Ability to give informed consent\n\nExclusion Criteria:\n\n* Hemolysis\n* Hematological disease with insufficient erythropoiesis\n* Patients without sufficient treatment of sideropenia, folate deficiency or vitamin B12 deficiency\n* Uncontrolled arterial hypertension\n* Treatment with rh-Erythropoetin during trial\n* Creatinin clearance \\< 50 ml/min\n* Insufficient bone marrow function (WBC count \\< 3.000/ml or platelets \\< 100.000/µl)\n* Other major symptomatic or uncontrolled illnesses not allowing to complete treatment protocol with the exception of symptoms caused by the primary disease\n* Second malignancy, except of completely resected basal cell carcinoma of the skin'}, 'identificationModule': {'nctId': 'NCT00204633', 'briefTitle': 'Darbepoetin Alfa in Patients With "Poor Prognosis" Germ Cell Tumor Treated With High-Dose Chemotherapy (HD-VIP)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': 'Randomized Phase II-Trial to Determine the Impact of Darbepoetin Alfa on the Frequency of RBC Transfusions in Patients With Metastatic "Poor Prognosis" Germ Cell Tumor Treated With High-Dose Chemotherapy (HD-VIP Regimen)', 'orgStudyIdInfo': {'id': 'jth_004'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Darbepoetin alfa', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '72076', 'city': 'Tübingen', 'country': 'Germany', 'facility': 'Medical Center II, University of Tuebingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}], 'overallOfficials': [{'name': 'Joerg T. Hartmann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'South West German Cancer Center, Medical Center II, University of Tuebingen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}}}}