Sarcoma, Soft TissuePhase 2NCT00204620
Bendamustin Hydrochloride in Patients With Soft Tissue Sarcoma (STS)
A Phase 2 study testing Bendamustin in people with Sarcoma, Soft Tissue, run by University Hospital Tuebingen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma, Soft Tissue
- What is being tested?
- Bendamustin
- How many people
- 28 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2002to Dec 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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°)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter Phase II Study With Bendamustin for Patients With Refractory Soft Tissue Sarcoma
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.
- Conditions
- Sarcoma, Soft Tissue
- Being tested
- Bendamustin
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BendamustinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startMar 2002
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcoma, Soft TissueStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Arbeitsgemeinschaft fur Internistische Onkologie, German Sarcoma Group
- Investigators
- Joerg T Hartmann, MD, Principal investigator, South West German Cancer Center, Medical Center II, University of Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00204620
- Sponsor's protocol ID
- jth_002
- Status last verified
- Apr 2007
- First submitted
- 13 Sep 2005
- Last updated
- 20 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Phase II Study With Bendamustin for Patients With Refractory Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT00204620
- Acronym / sponsor ID
- jth_002
- Conditions
- Sarcoma, Soft Tissue
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Arbeitsgemeinschaft fur Internistische Onkologie, German Sarcoma Group
- Study start
- Mar 2002
- Study completion
- Dec 2006 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bendamustin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joerg T Hartmann, MD principal investigator
South West German Cancer Center, Medical Center II, University of Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bendamustin in people with Sarcoma, Soft Tissue, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2007.