Mifamurtide Combined With Post-operative Chemotherapy for Newly Diagnosed High Risk Osteosarcoma Patients (SARCOME13)

STATUS

Recruiting
End date

Oct 4, 2028
participants needed

126
sponsor

UNICANCER

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Updated on 14 February 2022

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methotrexate

etoposide

doxorubicin

schwartz

metastasis

neutrophil count

cancer chemotherapy

ifosfamide

metastatic osteosarcoma

mifamurtide

Summary

Trial evaluating the impact on efficacy of mifamurtide as add-on treatment to post-operative chemotherapy compared to post-operative chemotherapy alone in first-line treatment of patients with high-risk osteosarcoma (defined as metastatic osteosarcoma at diagnosis or localised osteosarcoma with poor histological response).

Description

Multicentre, randomised, open-label, phase II trial, with 2 parallel groups. After pre-operative chemotherapy and surgery of the primary tumour and lung metastases (if applicable), patients presenting high-risk osteosarcoma (defined as metastatic osteosarcoma at diagnosis or localised osteosarcoma with poor histological response) will be randomised between 2 arms:

Control arm: post-operative chemotherapy alone (with regimens adapted to the age of patient)
Experimental arm : post-operative chemotherapy combined with mifamurtide

This randomised trial is part of a study recruiting all patients 50 years old with a newly diagnosed high-grade osteosarcoma.

Details

Condition	Osteosarcoma
Treatment	Mifamurtide, EI or M-API regimen depending on patient age
Clinical Study Identifier	NCT03643133
Sponsor	UNICANCER
Last Modified on	14 February 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Patient with a histologically proven, confirmed by experts pathologists panel (before surgery at the latest), high-grade osteosarcoma
	Registered at diagnosis into the study
	Primary tumour resected after pre-operative chemotherapy
	Osteosarcoma classified as high risk because of at least one risk factor
	presence of distant metastases or skip metastases at diagnosis
	and/or poor histological response to pre-operative chemotherapy (>10% residual viable cells on the analysis of the primary tumour surgical specimen)
	Pre-operative chemotherapy combining
	Methotrexate-Etoposide-Ifosfamide (M-EI regimen) for patients 25 years
	Doxorubicin-Cisplatin-Ifosfamide (API-AI regimen) for patients 26-50 years
	Screening laboratory values must meet the following criteria (using CTCAE v4) and should be obtained within 7 days prior to randomisation
	Absolute neutrophil count 1.0 x 10/L
	Platelets 100 x 10/L
	Haemoglobin 8.0 g/mL
	Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) 2.5 x upper limit of normal (ULN) in the absence of liver metastases or 5 x ULN in the presence of liver metastases
	Total Bilirubin 2 x ULN (except Gilbert Syndrome: <3.0 mg/dL) or Total Bilirubin 5.0 x ULN in the presence of liver metastases
	Creatinine clearance 60 mL/min/1.73 m according to the Schwartz or Cockcroft formula according to patient's age
	Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) done within 7 days prior to randomisation
	Provision of dated and signed written informed consent for the randomised trial prior to any study specific procedures, sampling and analyses
	Patient fit to undergo protocol treatment and follow-up
	Affiliation to a social insurance regimen
Exclusion Criteria
	Low grade osteosarcoma, parosteal or periosteal osteosarcoma
	Prior history of other malignancies other than study disease (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) unless the patient has been free of the disease for at least 3 years
	Osteosarcoma with multiple metastases for whom complete removal is not expected to be feasible even after shrinkage with chemotherapy
	Progressive disease at any site under initial chemotherapy, confirmed before randomisation time, and not totally resected during surgery
	Any medical condition precluding treatment with protocol chemotherapy
	Fractional Shortening <28% or left ventricular ejection fraction (LVEF) 50% before treatment (only for API post-operative chemotherapy) by echocardiogram or multigated acquisition (MUGA) scan
	Pregnancy or breast-feeding
	Hypersensitivity to the active substance or to any of the excipients
	Concurrent use of immunodepressive treatment such as cyclosporine, tacrolimus or other calcineurin inhibitors
	Concurrent use with high-dose non-steroidal anti-inflammatory drugs (NSAIDs, cyclooxygenase inhibitors)
	Inflammatory or auto-immune disease, allergy or asthma requiring a chronic use of steroid treatment that cannot be stopped
	Patients with positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
	Patients with positive tests for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating active or chronic infection

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Study Definition

Wikipedia

Mifamurtide Combined With Post-operative Chemotherapy for Newly Diagnosed High Risk Osteosarcoma Patients (SARCOME13)