Bendamustin Hydrochloride in Patients With Soft Tissue Sarcoma (STS)
Sarcoma, Soft Tissue
About this trial
This is an interventional treatment trial for Sarcoma, Soft Tissue
Eligibility Criteria
Inclusion Criteria: Histologically confirmed metastatic or non-resectable soft tissue sarcoma Evidence of progression or relapse after an anthracycline-based and/ or ifosfamide-based chemotherapy At least 1 bidimensionally measurable tumor lesion according to RECIST criteria No previous radiation therapy on the only measurable lesion Willingness to receive regular follow-up Life expectancy more than 3 months ECOG status >= 2 Patients aged 18 years and beyond leucocytes > 2500/µl, thrombocytes > 75000/µl) Serum creatine < 1,5 times the upper limit of normal value, GFR > 60/ml Written patient informed consent Ability to give informed consent Exclusion Criteria: Previous or concurrent radiation of the index lesion (radiation of single lesion is allowed if not the index lesion) 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) Active infection Prior therapy with Bendamustin hydrochloride 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 Symptomatic cardio- and/or cerebrovascular disease (NYHA-Scale III°) Interval since last chemotherapy < 4 weeks Evidence of CNS-metastases Evidence of pregnancy or lactation Woman of child-bearing potential without reliable methods of birth control
Sites / Locations
- Medical center II, University of Tuebingen