Status:
COMPLETED
Study on Efficacy and Tolerability of Vorinostat in Patients With Advanced, Metastatic Soft Tissue Sarcoma (STS)
Lead Sponsor:
Heidelberg University
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Soft Tissue Sarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Primary objective of the study is to investigate the efficacy of vorinostat in patients suffering from selected histological types of soft tissue sarcoma. Further evaluations relate to the safety and ...
Detailed Description
The treatment with vorinostat will be administered daily over 28 days. This period will be referred to as a therapy cycle. Two consecutive therapy cycles will be separated by a 7-days therapy break. I...
Eligibility Criteria
Inclusion
- Patients with verified, metastatic soft tissue sarcoma of the following histologies:
- undifferentiated highgrade pleomorphic sarcoma/pleomorphic malignant fibrous histiocytoma,
- undifferentiated pleomorphic sarcoma with grand cells/grand cell fibrotic histiocytoma,
- undifferentiated pleomorphic sarcoma with prominent inflammation/inflamed MFH,
- myxofibrosarcoma,
- liposarcoma,
- synovial sarcoma,
- rhabdomyosarcoma (pleomorph, alveolar und embryonal),
- leiomyosarcoma,
- adult fibrosarcoma,
- angiosarcoma,
- malignant hemangiopericytoma/ malignant solitaire fibrous tumor,
- malignant peripheral neurilemma tumor,
- extraskeletal mesenchymal chondrosarcoma,
- extraskeletal myxoid chondrosarcoma,
- undifferentiated sarcoma of non other specified (NOS) type.
- Verified relapse or disease progression at study inclusion, i.e. therapeutic failure of the first line therapy with anthracyclines,
- Measurable disease according to the RECIST criteria,
- Previous systemic therapy of advanced and/or metastatic disease,
- An interval of at least 4 weeks since the last surgery, chemotherapy or radiation,
- Age over 18,
- Following laboratory findings:
- ANC ≥ 1.0 x 10³/mm³,
- platelets ≥ 100.000/mm³,
- hemoglobin ≥ 9 g/dl,
- creatinin \< 1.5 x ULN (upper limit of normal),
- AST and ALT \< 2.5 x ULN,
- total bilirubin \< 1.5 x ULN,
- Life expectancy of at least 12 weeks,
- Negative pregnancy test,
- Consent for an effective contraception during and up to 6 month after the study completion.
- Written informed consent,
- Ability to understand the goal and the consequences of this trial.
Exclusion
- Proof of the following histologies:
- gastrointestinal stromal tumor (GIST),
- malignant mesothelioma,
- neuroblastoma,
- osteosarcoma,
- Ewing's sarcoma/PNET,
- Concurrent radio- or chemotherapy,
- Participation in another interventional trial within 4 weeks prior to the inclusion,
- Previous therapy with another HDAC-inhibitor (e.g. depsipeptide, MS-275, LAQ-824, PXD-101 und valproic acid). Patients, who underwent a therapy with valproic acid for treatment of seizures, can be included after a wash-out period of at least 30 days,
- Symptomatic brain metastases, that have not been treated by radiotherapy. The interval between the last radiation and the study inclusion must not be shorter than 30 days,
- Previous malignant disease (except for a non-melanoma of the skin and a carcinoma in situ of uterus), unless in complete remission and after the last therapy for at least 5 years,
- Ejection fraction \< 40 %,
- Nursing,
- Known allergy against the IMP or drugs with similar chemical structure or additives,
- Active hepatitis B and/or C and HIV-infection
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00918489
Start Date
May 1 2010
End Date
September 1 2013
Last Update
October 17 2018
Active Locations (7)
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1
Department of Hematology, Oncology, Rheumatology and Immunology, University Hospital Tübingen
Tübingen, Baden-Wurttemberg, Germany, D-72076
2
Department of Hematology, Hemostaseology, Oncology and Stemm Cell Transplantation, Medical School Hannover
Hanover, Niedersachen, Germany, D-30625
3
Department of Oncology, Hematology and Palliative Medicine, Marien Hospital Düsseldorf
Düsseldorf, North Rhine-Westphalia, Germany, D-40479
4
Comprehensive Cancer Center North, University Hospital Kiel
Kiel, Germany, 24105