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Bendamustin Hydrochloride in Patients With Soft Tissue Sarcoma (STS)

Primary Purpose

Sarcoma, Soft Tissue

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Bendamustin
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma, Soft Tissue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
April 19, 2007
Sponsor
University Hospital Tuebingen
Collaborators
Arbeitsgemeinschaft fur Internistische Onkologie, German Sarcoma Group
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1. Study Identification

Unique Protocol Identification Number
NCT00204620
Brief Title
Bendamustin Hydrochloride in Patients With Soft Tissue Sarcoma (STS)
Official Title
Multicenter Phase II Study With Bendamustin for Patients With Refractory Soft Tissue Sarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital Tuebingen
Collaborators
Arbeitsgemeinschaft fur Internistische Onkologie, German Sarcoma Group

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma, Soft Tissue

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Bendamustin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joerg T Hartmann, MD
Organizational Affiliation
South West German Cancer Center, Medical Center II, University of Tuebingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical center II, University of Tuebingen
City
Tuebingen
Country
Germany

12. IPD Sharing Statement

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Bendamustin Hydrochloride in Patients With Soft Tissue Sarcoma (STS)

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