Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT00204620
Status:
COMPLETED
Last Update Posted:
2007-04-20
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bendamustin Hydrochloride in Patients With Soft Tissue Sarcoma (STS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012509', 'term': 'Sarcoma'}], 'ancestors': [{'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069461', 'term': 'Bendamustine Hydrochloride'}], 'ancestors': [{'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-04', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-04-19', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2007-04-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Sarcoma, Soft Tissue']}, 'descriptionModule': {'briefSummary': 'The aims of this trial are to evaluate the efficacy of bendamustin in patients with metastatic soft tissue sarcoma who have progressed after or during an anthracycline-baesd chemotherapy and to assess the treatment of toxicity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed metastatic or non-resectable soft tissue sarcoma\n* Evidence of progression or relapse after an anthracycline-based and/ or ifosfamide-based chemotherapy\n* At least 1 bidimensionally measurable tumor lesion according to RECIST criteria\n* No previous radiation therapy on the only measurable lesion\n* Willingness to receive regular follow-up\n* Life expectancy more than 3 months\n* ECOG status \\>= 2\n* Patients aged 18 years and beyond\n* leucocytes \\> 2500/µl, thrombocytes \\> 75000/µl)\n* Serum creatine \\< 1,5 times the upper limit of normal value, GFR \\> 60/ml\n* Written patient informed consent\n* Ability to give informed consent\n\nExclusion Criteria:\n\n* Previous or concurrent radiation of the index lesion (radiation of single lesion is allowed if not the index lesion)\n* Insufficient liver function (bilirubin \\> 1.5 the upper limit of normal, prolongation of PT and aPTT \\> 1.5 the upper limit of normal; ASAT and ALAT \\> 3 the upper limit of normal (patients with liver metastases ASAT and ALAT \\> 5 the upper limit of normal)\n* Active infection\n* Prior therapy with Bendamustin hydrochloride\n* Prior malignancies (other than adequately treated carcinoma in situ (CIS) of the cervix, bladder urothelium, basal cell carcinoma or adenoma of the colon including pTIS,pTIN), unless treated with curative intent and without evidence of disease \\> 5 years\n* Symptomatic cardio- and/or cerebrovascular disease (NYHA-Scale III°)\n* Interval since last chemotherapy \\< 4 weeks\n* Evidence of CNS-metastases\n* Evidence of pregnancy or lactation\n* Woman of child-bearing potential without reliable methods of birth control'}, 'identificationModule': {'nctId': 'NCT00204620', 'briefTitle': 'Bendamustin Hydrochloride in Patients With Soft Tissue Sarcoma (STS)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': 'Multicenter Phase II Study With Bendamustin for Patients With Refractory Soft Tissue Sarcoma', 'orgStudyIdInfo': {'id': 'jth_002'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Bendamustin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'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'}, 'collaborators': [{'name': 'Arbeitsgemeinschaft fur Internistische Onkologie', 'class': 'OTHER'}, {'name': 'German Sarcoma Group', 'class': 'OTHER'}]}}}