Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01459484
Other study ID # ISG/OS-2
Secondary ID 2011-001659-36
Status Completed
Phase Phase 2
First received
Last updated
Start date June 23, 2011
Est. completion date April 30, 2024

Study information

Verified date May 2024
Source Italian Sarcoma Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a phase II multicentre, uncontrolled trial including patients ≤ 40 years with non-metastatic extremity high-grade osteosarcoma stratified according to P-glicoprotein expression


Description:

The main objective of the study is to evaluate the impact on event-free survival (EFS) of a multi-drug chemotherapy approach and mifamurtide treatment in patients with non-metastatic osteosarcoma of the extremities according to the expression of ABCB1/P-glycoprotein


Recruitment information / eligibility

Status Completed
Enrollment 225
Est. completion date April 30, 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers No
Gender All
Age group N/A to 40 Years
Eligibility Inclusion Criteria: - Histology confirmed diagnosis of extremities high grade osteosarcoma - Age = 40 years - Localized disease or presence of skip metastasis - Hepatic, renal and bone marrow normal function - LVEF > 50% - No previous surgery and/ or chemotheraputic osteosarcoma treatments, - No more than 4 weeks interval between histological diagnosis and start of chemotherapy - Informed consent to the study participation obtained. Exclusion Criteria: - Presence of metastases other than skip metastases - Periosteal Osteosarcoma, parostal osteosarcoma, secondary osteosarcoma, - Medical contra-indication to the drugs foreseen in the protocol, - Subject is pregnant or breast feeding - Mental or social conditions that can compromise a correct adherence to the protocol and its procedures

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Mifamurtide arm
PRE SUGERY TREATMENT: Methotrexate: 12g/m2 (3 cycles) Cisplatinum: 120mg/m2 (3 cycles) Doxorubicin: ADM 75mg/m2 (3 cycles) POST SURGERY TREATMENT for good responder patients with positive P-GLYCOPROTEIN Methotrexate 12g/m2 (10 Cycles) Cisplatinum 120mg/m2; Doxorubicin 90mg/m2 MEPACT 2 mg/m2 twice a week for the first 3 months the weekly for the next 6 months (total lenght treatment 44 weeks) POST SURGERY TREATMENT for poor responder patients with positive P-GLYCOPROTEIN Methotrexate 12g/m2; Cisplatinum 120mg/m2; Doxorubicin 90mg/m2 ifosfamide 15g/m2 MEPACT 2 mg/m2 twice a week for the first 3 months the weekly for the next 6 months (total lenght treatment 44 weeks) All the product are used as commercial formulation
Other:
3 drugs arm
High grade osteosarcoma who do not over express ABCB1/P-glycoprotein will be treated with a standard 3-drugs regimen PRE-SUGERY TREATMENT: Methotrexate: 12g/m2 (3 cycles) Cisplatinum: 120mg/m2 (3 cycles) Doxorubicin: ADM 75mg/m2 (3 cycles) POST SURGERY TREATMENT: Methotrexate 12g/m2 (10 cycles) Cisplatinum 120mg/m2; Doxorubicin 90mg/m2 Total lenght 34 weeks All the product are used as commercial formulation

Locations

Country Name City State
Italy IRCCS Istituto ortopedico Rizzoli Bologna
Italy I.R.C.C. - Unit of Medical Oncology Candiolo Torino
Italy A.O. Universitaria Meyer Firenze
Italy Istituto Giannina Gaslini Genova
Italy FONDAZIONE IRCCS Istituto Nazionale dei Tumori Milano
Italy Istituto Nazionale Tumori "Fondazione G. Pascale" Napoli
Italy Azienda Ospedaliera di Padova Padova
Italy Istituti Fisioterapici Ospitalieri di Roma Roma
Italy Ospedale Pediatrico Bambin Gesu' Roma
Italy Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology Torino
Italy Presidio Sanitario Gradenigo Torino TO

Sponsors (1)

Lead Sponsor Collaborator
Italian Sarcoma Group

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Serra M, Pasello M, Manara MC, Scotlandi K, Ferrari S, Bertoni F, Mercuri M, Alvegard TA, Picci P, Bacci G, Smeland S. May P-glycoprotein status be used to stratify high-grade osteosarcoma patients? Results from the Italian/Scandinavian Sarcoma Group 1 treatment protocol. Int J Oncol. 2006 Dec;29(6):1459-68. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Events free survival Onset of any event. An event is the defined as disease recurrence (local or distant), death for disease or any other cause, onset of secondary tumors or the last follow-up examination After 5 years from the time to first day of chemotherapy for all patients and from the date of surgery for the Pgp overexpression patients stratified according to tumor necrosis (Good Responders and Poor Responders).
Secondary Overall Survival Time elapsed for the diagnosis to the death for any cause or to the last follow-up examination. After 5 years from the time to first day of chemotherapy for all patients and from the date of surgery for the Pgp overexpression patients stratified according to tumor necrosis (Good Responders and Poor Responders).
See also
  Status Clinical Trial Phase
Completed NCT00026780 - Eligibility Screening for a NCI Pediatric Oncology Branch Research Study
Not yet recruiting NCT05515068 - Registry For Children, Adolescents And Adults With Osteosarcoma And Biologically Related Bone Sarcomas
Completed NCT02383901 - A Retrospective Non-intervention Study to Characterize FOlate Rescue Treatment in Osteosarcoma Patients Treated With HDMTX N/A
Active, not recruiting NCT01758666 - A Clinical Research on the Relation of Blood Drug Concentration and Calcium Folinate Rescued in High-dose MTX Therapy N/A
Completed NCT01674101 - Effects of Preoperative Physical Therapy in Patients With Lower Extremity Malignancy N/A
Completed NCT01615640 - Diffusion Study on Patients With Osteosarcoma
Completed NCT00523419 - Chemotherapy for Patients With Osteosarcoma Phase 2
Completed NCT00520936 - A Study of Pemetrexed in Children With Recurrent Cancer Phase 2
Completed NCT00132158 - ZD1839 and Oral Irinotecan in Treating Young Patients With Refractory Solid Tumors Phase 1
Not yet recruiting NCT04319874 - Phase II Clinical Trial Scheme of Ganoderma Lucidum Spore Powder for Postoperative Chemotherapy of Osteosarcoma Phase 2
Recruiting NCT06029218 - Analysis of the Toxicity and Efficacy of Daily 1 vs 2 Beam Proton Therapy N/A
Recruiting NCT05642455 - SPEARHEAD-3 Pediatric Study Phase 1/Phase 2
Recruiting NCT06117878 - Safety and Efficacy of NK510 to Treat Osteosarcoma and Soft Tissue Sarcoma Early Phase 1
Not yet recruiting NCT04316091 - A Phase I Clinical Trial of Neoadjuvant Chemotherapy With/Without SPIONs/SMF for Patients With Osteosarcoma Phase 1
Recruiting NCT03932058 - Proteomics Research of Osteosarcoma
Withdrawn NCT01236586 - RO4929097 in Children With Relapsed/Refractory Solid or CNS Tumors, Lymphoma, or T-Cell Leukemia Phase 1
Completed NCT00743496 - A Phase I Trial Of The Humanized Anti-GD2 Antibody In Children And Adolescents With Neuroblastoma, Osteosarcoma, Ewing Sarcoma and Melanoma Phase 1
Recruiting NCT04040205 - Abemaciclib for Bone and Soft Tissue Sarcoma With Cyclin-Dependent Kinase (CDK) Pathway Alteration Phase 2
Recruiting NCT05970497 - A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors Phase 1
Active, not recruiting NCT03628209 - Nivolumab or Nivolumab and Azacitidine in Patients With Recurrent, Resectable Osteosarcoma Phase 1/Phase 2