EUCTR2012-000615-84-DEActive, not recruitingPhase 1
A Mechanistic Study Of Mifamurtide (MTP-PE) In Patients With Metastatic And/Or Recurrent Osteosarcoma - MEMOS: A Eurosarc Study of Mifamurtide in advanced osteosarcoma
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- niversity of Oxford
- Enrollment
- 40
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •A patient will be eligible for inclusion in this study if all of the following criteria apply.
- •1.Relapsed osteosarcoma (first, second, third or any relapse, patient has recovered from chemotherapy and any other investigational drug/agent treatment, radiotherapy or surgical procedure).
- •2.Histological confirmed diagnosis of osteosarcoma at original presentation.
- •3.Tumour at biopsy accessible or resectable site.
- •4.Progressive disease documented by imaging within 3 months of entry into the trial.
- •5.At least one measurable lesion on CT scan (RECIST) performed in past 21 days prior to trial entry.
- •6.Male or female, age = 16 years to 65 (or =18 based on institutional practice for Teenage and Young Adult Cancer patients).
- •7.Life expectancy of at least 3 months.
- •8.WHO performance score of 0 – 2.
- •9.The patient is willing and able to comply with the protocol and scheduled follow-up visits and examinations.
- •10.Written (signed and dated) informed consent.
- •11.Cardiac shortening fraction = 28% or ejection fraction = 45%
- •12.Renal function is adequate for ifosfamide treatment (GFR as per table below, other renal function screening tests as per local practice)
- •13.Haematological and biochemical indices within the ranges detailed in the protocol
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 8
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 32
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
Exclusion Criteria
- •Patient will not be eligible for the trial if any of the following apply:
- •1.Pregnant or breast-feeding woman. Men or women of childbearing potential unless effective methods of contraception are used during study treatment and for at least 7 days after the last mifamurtide dose.
- •2.Previous treatment with mifamurtide or a mifamurtide-like drug* in a clinical trial setting for the treatment of metastatic and/or recurrent osteosarcoma in the six months prior to registration.
- •3.Contraindications to lung biopsies
- •4. Hypersensitivity to ifosfamide or any component of the formulation.
- •5.Previously diagnosed brain metastases.
- •6.Significant active cardiac disease including: uncontrolled high blood pressure (no greater than 2 standard deviations above the mean for age for systolic blood pressure (SBP) and diastolic blood pressure (DBP), unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, or serious cardiac arrhythmias and with a history of pericarditis and myocarditis
- •7.Treatment with any other investigational agent, or participation in another interventional clinical trial within 21 days prior to enrolment.
- •8.Major surgery within 21 days prior first study biopsy
- •9.Currently taking of high-dose non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroid treatment
- •10.Concurrent use of ciclosporin or other calcineurin inhibitors.
- •11.Any psychological, social or medical condition, physical examination finding or a laboratory abnormality that the Investigator considers would make the patient a poor trial candidate or could interfere with protocol compliance or the interpretation of trial results.
- •12.Any other active malignancy, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and non-melanoma skin lesions.
- •13.Patients who are known to be serologically positive for Hepatitis B, Hepatitis C or HIV.
- •* mifamurtide-like drugs include GMCSF, interferon and other macrophage activating molecules.
Investigators
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