Chemoterapy Protocols

PM1183-B-005-14 Clinical Trial
Start date: 2015
Investigators: Alessandra Longhi MD - Emanuela Palmerini MD
Study Coordinator: Dr Emanuela Marchesi
A Multicenter Phase II Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors (Ewing Sarcoma cohort only).

rEECur Clinical Trial
Start date: 2015
Investigators: Alessandra Longhi MD - Emanuela Palmerini MD
Study Coordinator: Dr Emanuela Marchesi
International Randomised Controlled Trial of Chemotherapy for the Treatment of Recurrent and Primary Refractory Ewing Sarcoma.

ISG/Os2 Clinical Trial
Start date: 2011 – Investigators: Dr Alessandra Longhi MD - Emanuela Palmerini MD  
Study Coordinator: Dr Emanuela Marchesi
No profit, multicenter, prospective, clinical trial, for the treatment of high grade non-metastatic osteosarcoma in ≤ 40 years old patients, based on ABCB1/P-glycoprotein expression.

ISG STS 10.01 Clinical Trial
Start date: 2011 – Investigators: Alessandra Longhi MD - Emanuela Palmerini MD
Study Coordinator: Dr Emanuela Marchesi
No profit, multicenter, international, randomized clinical trial, for the treatment of localized high-risk soft tissue sarcomas of the extremities and trunk wall in adults on the basis of standard neoadjuvant chemotherapy vs histotype-tailored.

ISG AIEOP/EW2 Clinical Trial: neo adjuvant protocol in the treatment of Ewing/PNET metastatic sarcoma
Start date: 2010 – Investigators: Alessandra Longhi MD - Massimo Abate MD
No profit, multicenter, prospective study for treatment of Ewing metastatic sarcoma (lung metastasis/single bone metastases). Patients will receive an intensified treatment with high doses of busulfan and melfalan and peripheral stem cells transplant, followed by a maintenance treatment with cyclophosphamide and celecoxib.

Denosumab in bone Giant Cell Tumor Clinical trial
Start date: 2009 – Investigators: Alessandra Longhi MD - Emanuela Palmerini MD  
Study Coordinator: Dr Emanuela Marchesi
An open lable, multi-center phase 2 study of Denosumb (monoclonal antibody anti-RANNKL) in subject with metastatic or localized bone Giant Cell Tumor.

ISG AIEOP/EW1 Clinical Trial: neo adjuvant protocol in the treatment of Ewing/PNET non metastatic sarcoma
Start date: 2009 – Investigators: Alessandra Longhi MD
Phase III, no profit, multicenter, trial for the treatment of localized Ewing’s Sarcoma. Patients with non metastatic Ewing's Sarcoma will be randomized into 2 different groups: standard chemotherapy treatment or into the experimental group with dose intensification and shorter length chemotherapy. The induction phase will be followed by a subsequent maintenance treatment based on the induction treatment response.

Study with Glivec (CSTI571 basket 1). Phase  II study
Starting year: 2007 - Representative for IOR: Alessandra Longhi MD
This protocol uses imatinib mesilate (Glivec®, Novartis) for patients with desmoid tumors or advanced/metastatic chondrosarcoma that cannot be operated. c-KIT or PDGFR immunohistochemical expression is mandatory.

Study on the utilization of troponin dosage for the early diagnosis of anthracycline cardiotoxicity in patients under treatment for bone sarcomas
In charge: Alessandra Longhi MD. Aim of the study is the early diagnosis of possible anthracycline cardiotoxicity, through the monitoring of troponin hematic dosage vs. TDI echocardiogram, in patients under adjuvant chemotherapy or treated for metastatic diseases with adriamycin in doses <240 mg/m2.

 

Clinical trials closed after enrolment

 

PLX108-10 Clinical Trial
Start date: 2015
Investigators: Alessandra Longhi MD - Emanuela Palmerini MD
Study Coordinator: Dr Emanuela Marchesi
A Double-blind, Randomized, Placebo-controlled Phase 3 Study of Orally Administered PLX3397 in Subjects with Pigmented Villonodular Synovitis or Giant Cell Tumor of the Tendon Sheath.

LINES Clinical Trial
Start date: 2015
Investigators: Alessandra Longhi MD - Emanuela Palmerini MD
Study Coordinator: Dr Emanuela Marchesi
Phase II trial of Linsitinib (anti-IGF-1R/IR) in patients with relapsed and/or refractory Ewing.

MEMOS Clinical Trial
Start date: 2015
Investigators: Alessandra Longhi MD - Emanuela Palmerini MD
Study Coordinator: Dr Emanuela Marchesi
A Mechanistic Study Of Mifamurtide (MTP-PE) In Patients With Metastatic And/Or Recurrent Osteosarcoma.

ALDOXORUBICIN-P3-STS-01 Clinical Trial
Start date: 2014 – Investigators: Alessandra Longhi MD - Emanuela Palmerini MD  
Study Coordinator: Dr Emanuela Marchesi
A Multicenter, Randomized, Open-Label Phase 3 Study to Investigate the Efficacy and Safety of Aldoxorubicin Compared to Investigator’s Choice in Subjects with Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcomas Who Either Relapsed or Were Refractory to Prior Non-Adjuvant Chemotherapy.

GEIS-32 Clinical Trial
Start date: 2014 – Investigators: Alessandra Longhi MD - Emanuela Palmerini MD  
Study Coordinator: Dr Emanuela Marchesi
A Phase II Open-Label Trial of Pazopanib Administered as a Single Agent in Patients with Unresectable or Metastatic Solitary Fibrous Tumor (SFT) and Extraskeletal Myxoid Chondrosarcoma (EMC).

ISG TR1US Clinical Trial
Start date: 2014 – Investigators: Alessandra Longhi MD - Emanuela Palmerini MD
Study Coordinator: Dr Emanuela Marchesi
Safety and activity of trabectedin as first line treatment in advanced soft tissue sarcoma (STS) patients unfit to receive standard chemotherapy: a prospective phase II study with clinical molecular correlates (TR1US).
 
EUROBOSS (European over 40 Bone Sarcoma Study): Treatment protocol in patients over 40, with musculoskeletal sarcomas
Starting year: 2002 - Chief investigator: Alessandra Longhi MD
International clinical study performed in collaboration with the Scandinavian Sarcoma Group and the Cooperative Osteosarcoma Study group. Includes patients with high-grade malignancy spindle cells skeletal sarcomas patients aged between 41 and 65 years old. Patients with diagnosis of primary and secondary osteosarcoma, malignant fibrous histiocytoma, leiomyosarcoma, dedifferentiated chondrosarcoma, and fibrosarcoma are included. 

Content updated 19/10/2017 - 12:57
Content edited by: Alessandra Longhi MD (alessandra.longhi@ior.it)
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