Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Sarcoma

Carcinosarcoma

Mixed Tumor, Mullerian

Leiomyosarcoma

Endometrial Stromal Tumors

Adenoma, Pleomorphic

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

Endometrial Neoplasms

Uterine Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Soft Tissue Sarcoma

Malignant Mixed Mullerian Tumor

Uterine Sarcoma

Uterine Carcinosarcoma

Antineoplastic Agents

All Drugs and Chemicals

Vorinostat

Histone Deacetylase Inhibitors

Enzyme Inhibitors

Vorinostat, 400 mg orally once daily for the first 14 days of a 21 day cycle Treatment will be continued for 4 cycles. Patients with a response or stable disease after 4 cycles will be continued on vorinostat therapy at the tolerated schedule and dosage until disease progression, unacceptable toxicity or patients' withdrawal of the consent. At the maximum, a total of 12 cycles will be administered over a period of 9 months.

Vorinostat Oral Capsule

Edgar Petru, MD

Uterine sarcomas are rare tumors with a poor prognosis.

The main purpose of this phase II proof-of-principle- pilot study is to test the efficacy of the hydroxamic acid-based Histone deacetylase inhibitor (HDACI) Vorinostat (SAHA) as monotherapy in patients with HDAC-positive, progressive, metastatic uterine sarcomas and mixed epithelial and mesenchymal tumors after prior anti-proliferative therapy.

This is an open-label, single arm, proof of concept-study of the HDAC-inhibitor vorinostat in patients with refractory uterine sarcoma that have been pre-tested for an high expression of HDAC. Patients will receive Vorinostat, 400 mg (4 capsules á 100mg of Zolinza) orally once daily for the first 14 days of a 21 day cycle. Treatment will be continued for 4 cycles (treatment period 1). Patients with a response or stable disease after 4 cycles as determined by computed tomography (CT) of target an non target-lesions will be continued on vorinostat therapy at the tolerated schedule and dosage until disease progression, unacceptable toxicity or patients' withdrawal of the consent. At the maximum, a total of 12 cycles will be administered over a 9 months period (treatment periods 2 and 3).

The investigated condition occurs exclusively in women

Vorinostat (SAHA) in Uterine Sarcoma

A Pilot Study of Peroral Vorinostat (SAHA) in Patients With Refractory Histone Deacetylase-positive Uterine Sarcoma

Change from Baseline Tumor Size to last available observation with respect to progress as defined by RECIST 1.1 (CT-Scan every 12 weeks up to 9 months)

This endpoint is evaluated by the amount of clinical adverse experiences.

Medical University of Graz

Vorinostat Oral Capsules 400mg daily

Vorinostat Oral Capsule: Vorinostat, 400 mg orally once daily for the first 14 days of a 21 day cycle Treatment will be continued for 4 cycles. Patients with a response or stable disease after 4 cycles will be continued on vorinostat therapy at the tolerated schedule and dosage until disease progression, unacceptable toxicity or patients' withdrawal of the consent. At the maximum, a total of 12 cycles will be administered over a period of 9 months.

Vorinostat, Zolinza Oral Capsules

Age, Categorical

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Austria

Region of Enrollment

Statistical evaluation was not possible as only 1 Patient reached end point 1.

Prof. Edgar Petru

Only one Patient reached the first end Point. Statistical Evaluation was therefore not possible. For this reason no data are reported in the data table.

Progression-free Survival (PFS)

Only one Patient reached the first end Point. Statistical Evaluation was therefore not possible.

For this reason no data are reported in the data table.

Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

Overall Study

Patients who received treatment for EST Patients with EST diagnosis prior August 2016

Patients who will receive treatment for EST Patients with EST diagnosis after August 2016

Surgery and/or Chemotherapy and or/radiotherapy for EST treatment according to disease guidelines: no specific treatment is imposed by protocol (observational study)

Treatment for EST

Gianluca Ignazzi, PhD

Toni Ibrahim, MD

Paolo G. Casali, MD

Tommaso M. De Pas, MD

Antonio Russo, MD

Angela Buonadonna, MD

Antonella Brunello, MD

Giovanni Grignani, MD

Maria Abbondanza Pantaleo, MD

Silvia Gasperoni, MD

Daniela Greto, MD

Giacomo G Baldi, MD

Bruno Vincenzi, MD

Virginia Ferraresi, MD

Paolo G Casali, MD

Observational, retrospective and prospective study on Endometrial Stromal Tumor (EST)

Observational, retrospective and prospective study on EST aimed to understand more about its biology, natural history and antitumor activity of different treatment options.

This study will collect data in prospective and retrospective way of patients affected by EST and treated according disease guidelines and local practices.

The study will also review the diagnosis by a central expert pathologist in order to its confirmation

Paraffin-embedded pathologic tissue used for diagnostic confirmation purposes only

Observational Study on Endometrial Stromal Tumors

Endometrial Stromal Tumors: an Observational Study

Aggregate anonymized results will be available upon request at the end of the study

Collection of data on the natural history of endometrial stromal tumors

Highlight some main issues in pathologic diagnosis of these tumors and their classification

Number and type of chemotherapy agents received for EST treatment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Vorinostat (SAHA) in Uterine Sarcoma	NCT03509207	Leiomyosarcoma Endometrial Str... Carcinosarcomas...	Vorinostat Oral...	18 Years -	Medical University of Graz
Observational Study on Endometrial Stromal Tumors	NCT02829437	Endometrial Str...	Treatment for E...	18 Years - 80 Years	Italian Sarcoma Group

Spots Global Cancer Trial Database for endometrial stromal tumors