Phase II Studie zur Wirksamkeit und Verträglichkeit von Vorinostat bei Patienten mit fortgeschrittenen, metastasierten Weichteilsarkomen.English title:A Phase II Study to Investigate the Efficacy and Tolerability of Vorinostat in Patients Suffering from Advanced, Metastatic Soft Tisssue Sarcoma. - SAHA-I

Phase 1

• Conditions: Subjects suffering from advanced, metastatic soft tissue sarcoma.; MedDRA version: 16.0Level: LLTClassification code 10015838Term: Extraskeletal chondrosarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 16.0Level: PTClassification code 10061527Term: NeurofibrosarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 16.0Level: PTClassification code 10025566Term: Malignant haemangiopericytomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 16.0Level: LLTClassification code 10008733Term: Chondromyxoid fibromaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 16.0Level: PTClassification code 10045515Term: Undifferentiated sarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 16.0Level: PTClassification code 10024627Term: LiposarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 16.0Level: LLTClassification code 10016637Term: Fibrosarcoma NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 16.0Level: PTClassification code 10025552Term: Malignant fibrous histiocytomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 16.0Level: PTClassification code 10039022Term: RhabdomyosarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2008-008513-19-DE
• Lead Sponsor: niversity Hospital Heidelberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-06-23
• Last Update Posted: 19 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Patients with verified, metastatic soft tissue sarcoma of following histologies:
a. Undifferentiated highgrade pleomorphic sarcoma/pleomorphic malignant fibrous histiocytoma,
b. Undifferentiated pleomorphic sarcoma with grand cells/ grand cells fibrotic histiocytoma,
c. Undifferentiated pleomorphic sarcoma with prominent inflammation/ inflammated MFH,
d. Myxofibrosarcoma,
e. Liposarcoma,
f. Synovial sarcoma,
g. Rhabdomyosarcoma (pleomorphic, alveolar und embryonal),
h. Leiomyosarcoma,
i. Adult fibrosarcoma,
j. Angiosarcoma,
k. Malignant haemangiopericytoma/ malignant solitaire fibrous tumor,
l. Malignant peripheral neurilemma tumor,
m. Extraskeletal mesenchymal chondrosarcoma,
n. Extraskeletal myxoid chondrosarcoma,
o. Undifferentiated sarcoma of NOS (not otherwise specified) type.
2. Verified relapse or disease progression at the study inclusion, i.e. therapeutic failure of the first line therapy with antracyclines,
3. Measurable disease according to RECIST criteria,
4. Previous systemic therapy of advanced and/or metastatic disease,
5. An interval of at least 4 weeks to the last surgery, chemotherapy or radiation,
6. Age over 18,
7. Following laboratory findings:
a. ANC = 1.0 x 10³/mm³,
b.Platelets = 100.000/mm³,
c. haemoglobin = 9 g/dl,
d. creatinine < 1.5 x ULN (upper limit of normal),
e. AST und/oder ALT < 2.5 x ULN,
f. total bilirubin < 1.5 x ULN,
8. Life expectancy of at least 12 weeks,
9. Negative pregnancy test,
10. Consent to an effective contraception during and up to 6 month after the study completion,
11. Written informed consent,
12. Ability to understand the goal and consequences of this clinical trial.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Proof of the following histologies:
a. gastrointestinal stromal tumor (GIST),
b. malignant mesothelioma,
c. neuroblastoma,
d. osteosarcoma,
e. Ewing's sarcoma/PNET,
2. Concurrent radio- or chemotherapy,
3. Participation in another interventional trial within 4 weeks prior to the inclusion,
4. 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,
5. 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,
6. 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,
7. Ejection fraction < 40 %,
8. Nursing,
9. Known allergy against the IMP or drugs with similar chemical structure or additives,
10. Active hepatitis B and/or C and HIV-infection

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified