OsteosarcomaPhase 2MEMOSNCT02441309
A Eurosarc Study of Mifamurtide in Advanced Osteosarcoma (MEMOS)
A Phase 2 study testing Mifamurtide and Ifosfamide in people with Osteosarcoma, run by University of Oxford at 8 sites in 5 countries.
Trial summary
This is a Bayesian designed multi-arm, multi-centre, open label phase II study. The target sample size of 40 patients will be recruited from up to 8 EU countries, but this may be revised in light of the interim analysis. Patients with relapsed or metastatic osteosarcoma will be divided into three treatment groups. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Osteosarcoma
- What is being tested?
- Mifamurtide and Ifosfamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 8 sitesin 5 countries
- Study dates
- Oct 2014to 4 Nov 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Relapsed osteosarcoma (first, second, third or any relapse, patient has recovered from chemotherapy and any other investigational drug/agent treatment, radiotherapy or surgical procedure).
- Histological confirmed diagnosis of osteosarcoma at original presentation.
- Tumour at biopsy accessible or resectable site.
- Progressive disease documented by imaging within 3 months of entry into the trial.
- At least one measurable lesion on CT scan (RECIST) performed in past 21 days prior to trial entry.
- Male or female, age ≥ 16 years to 65 (or ≥18 based on institutional practice for Teenage and Young Adult Cancer patients).
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- Life expectancy of at least 3 months.
- WHO performance score of 0 - 2.
- The patient is willing and able to comply with the protocol and scheduled follow-up visits and examinations.
- Written (signed and dated) informed consent.
- Cardiac shortening fraction ≥ 28% or ejection fraction ≥ 45%
- Renal function is adequate for ifosfamide treatment (GFR as per table below, other renal function screening tests as per local practice)
- Haematological and biochemical indices within the ranges shown below:
- Lab Test Value required
- Haemoglobin (Hb) ≥ 9 g/dL (Previous transfusion is allowed)
- Absolute neutrophil count (ANC) >=1.0 x 10*9/L without growth factor support
- Platelet count > 80.x 10*9/L (Previous transfusion is allowed)
- Total bilirubin <1.5 times the upper limit of normal (ULN) for age (except for Gilbert's syndrome patients)
- Serum alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) <2.5 × ULN for age, <2.5 × ULN for age
- Serum creatinine Normal range for age
- Glomerular filtration rate (GFR) (calculated as 51Cr-EDTA/99mTc-DTPA clearance) >40ml/min if deemed resectable (for Arm A), >60ml/min if not deemed resectable (for Arm B or C)
Who cannot join
- 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 (see section 5.1 Informed consent - Contraceptive/ Pregnancy counselling).
- 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.
- Contraindications to lung biopsies.
- Hypersensitivity to ifosfamide or any component of the formulation.
- Previously diagnosed brain metastases.
- 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
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- Treatment with any other investigational agent, or participation in another interventional clinical trial within 21 days prior to enrolment.
- Major surgery within 21 days prior to first study biopsy
- Currently taking high-dose non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroid treatment
- Concurrent use of ciclosporin or other calcineurin inhibitors.
- 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.
- Any other active malignancy, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and non-melanoma skin lesions.
- Patients who are known to be serologically positive for Hepatitis B, Hepatitis C or HIV.
- mifamurtide-like drugs include GCSF, GMCSF, interferon and other macrophage activating molecules.
Trial locations and contacts
8 sites in 5 countries.
8 sites in 5 countries
United Kingdom4 sites
Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF
University College London Hospitals NHS Foundation Trust
London, NW1 2BU
Christie Hospital NHS Foundation Trust
Manchester, M20 4BX
Oxford University Hospitals NHS Foundations Trust
Oxford, OX3 7LE
Germany1 site
Pediatric Hematology and Oncology, University Hospital Münster
Münster, 48149
Netherlands1 site
Department of Clinical Oncology, Leiden University Medical Center
Leiden, Postzone K1-P, P.O. Box 9600
About this study
Official title: A Mechanistic Study Of Mifamurtide (MTP-PE) In Patients With Metastatic And/Or Recurrent Osteosarcoma
This is a Bayesian designed multi-arm, multi-centre, open label phase II study. The target sample size of 40 patients will be recruited from up to 8 EU countries, but this may be revised in light of the interim analysis. Patients with relapsed or metastatic osteosarcoma will be divided into three treatment groups. They will all either have surgery or a biopsy before and after six weeks exposure to either Mifamurtide alone, Ifosfamide alone, or Mifamurtide combined with Ifosfamide. They will then receive further treatment to a maximum of 42 or 36 weeks in total (depending on Arm), with all patients being able to receive 36 weeks of Mifamurtide treatment.
Read the detailed description
Osteosarcoma (OS) is the most common primary tumour arising from bones. There is currently no approved treatment other than surgery for metastatic or recurrent osteosarcoma refractory to chemotherapy. Patients deemed unresectable normally receive chemotherapy prior to attempted resection. The addition of chemotherapy to surgery for metastatic or recurrent osteosarcoma may improve response rates. MEPACT (Mifamurtide, MTP-PE) is licensed for use in the adjuvant osteosarcoma setting; indicated in children, adolescents and young adults for the treatment of high-grade resectable non-metastatic osteosarcoma after macroscopically complete surgical resection. It is used in combination with post-operative multi-agent chemotherapy. This is a Bayesian designed multi-arm, multi-centre open-label phase II study in patients with metastatic and/or recurrent osteosarcoma, which will investigate why some patients with osteosarcoma may respond better than others to mifamurtide given alone or in combination with ifosfamide. Patients with relapsed or metastatic osteosarcoma will be divided into three treatment groups (Arms). Depending on their current disease status, patients may be either Registered to Arm A (resectable group), to receive Mifamurtide alone; or Randomised to Arm B/C (non-resectable group), to receive mifamurtide in combination with ifosfamide. Arm A - Mifamurtide alone; Arm B - Ifosfamide alone for 6 weeks then Ifosfamide + mifamurtide for 6 weeks, then mifamurtide alone for 30 weeks; Arm C - Ifosfamide + mifamurtide for 12 weeks then mifamurtide alone for 24 weeks. All participants will receive 36 weeks or more of mifamurtide. Biopsies (or resected tumour samples) will be obtained before and after 6 weeks of therapy interval in order to determine the pharmacodynamic endpoints. The target sample size is 40 patients. An interim analysis will be performed for the primary efficacy endpoint.
- Conditions
- Osteosarcoma
- Being tested
- Mifamurtide, Ifosfamide
- Keywords
- Metastatic and/or Recurrent Osteosarcoma
- Medical subject headings
- Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MifamurtideDrug
IfosfamideDrug
| Study group | Role | What they receive |
|---|---|---|
| A. Mifamurtide only | Experimental | Treatment Weeks 1-6 (post 1st biopsy/resection):
Mifamurtide 2mg/m2, IV infusion, twice/week, with each infusion given at least 3 days apart, for 6 weeks.
Treatment Weeks 7-12 (post 2nd biopsy/resection):
Mifamurtide 2mg/m2, IV infusion, twice/week, with each infusion given at least 3 days apart, for 6 weeks.
Treatment Weeks 13-36:
Mifamurtide 2mg/m2, IV infusion, once/week. Receives: Drug: Mifamurtide |
| B. Ifosfamide (Followed by Mifamurtide) | Experimental | Treatment Weeks 1-6: Day 1 of 21: Ifosfamide 12-15g/m2 IV infused over 4-5 days as per local practice. Repeated every 21 days for 2 cycles (3 weeks=1 cycle).
Treatment Weeks 7-12 (post 2nd biopsy/resection): Day 1 of 21: Ifosfamide 12-15g/m2 IV infused over 4-5 days once every 21 days for two cycles (3 weeks=1 cycle). Ifosfamide administered as per local practice, including concurrent dosing with mesna. Plus mifamurtide 2mg/m2, IV infusion, twice/week. Ifosfamide infusion started 24 hours prior to mifamurtide. Mifamurtide given on day 2 and either day 5 or day 6.
Treatment Weeks 13-18: Mifamurtide 2mg/m2, IV infusion, twice/week. Treatment Weeks 19-42: Mifamurtide 2mg/m2, IV infusion, once/week. Receives: Drug: Mifamurtide; Drug: Ifosfamide |
| C. Ifosfamide + Mifamurtide | Experimental | Treatment Weeks 1-6:
Day 1 of 21: Ifosfamide 12-15g/m2 IV infusion over 4-5 days once every 21 days for two cycles (3 weeks=1 cycle).
Plus Mifamurtide 2mg/m2, IV infusion, twice per week, each given at least 3 days apart, for 6 weeks.
Ifosfamide infusion started 24 hours prior to mifamurtide. Mifamurtide given on day 2 and either day 5 or day 6.
Treatment Weeks 7-12 (post 2nd biopsy/resection):
Day 1 of 21: Ifosfamide 12-15g/m2 IV infusion over 4-5 days once every 21 days for two cycles (3 weeks = 1 cycle).
Plus Mifamurtide 2mg/m2, IV infusion, twice per week, given at least 3 days apart, for 6 weeks. Ifosfamide infusion started 24 hours prior to mifamurtide. Mifamurtide given on day 2 and either day 5 or day 6.
Treatment Weeks 13-36: Mifamurtide 2mg/m2, IV infusion, once/week. Receives: Drug: Mifamurtide; Drug: Ifosfamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biological Response Data Based on Pharmacodynamic Endpoints on Tumour Biopsy Material
Biological response data based on pharmacodynamic endpoints on tumour biopsy material including macrophage infiltration and innate immune activation.
Measured: Change from Baseline to after 6 weeks of treatment
Radiological Response Defined as Complete or Partial Response and Assessed Using RECIST Criteria
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) assessed by CT or MRI:
Complete Response (CR): Disappearance of all target and non-target lesions Partial Response (PR): >=30% decrease in the sum of the longest diameter of target lesions, AND no evidence of progression in non-target lesions, AND no new lesions Stable Disease (SD): sum of longest diameter of target lesions between PR and PD values, AND no evidence of progression in non-target lesions, AND no new lesions Progressive Disease (PD): >20% increase in the sum of the longest diameter of target lesions, OR evidence of progression in non-target lesions, OR evidence of new lesions
Measured: Change from Baseline to after 6 weeks of treatment
Secondary outcomes (6)
Objective Radiological Response Based on RECIST v1.1
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) assessed by CT or MRI:
Complete Response (CR): Disappearance of all target and non-target lesions Partial Response (PR): >=30% decrease in the sum of the longest diameter of target lesions, AND no evidence of progression in non-target lesions, AND no new lesions Stable Disease (SD): sum of longest diameter of target lesions between PR and PD values, AND no evidence of progression in non-target lesions, AND no new lesions Progressive Disease (PD): >20% increase in the sum of the longest diameter of target lesions, OR evidence of progression in non-target lesions, OR evidence of new lesions
Measured: Change from Baseline to after 12, 18, 24 & 36 weeks and end of treatment visit
Number of Patients Experiencing a Grade 3 or More Severe Adverse Event (Graded According to CTCAE Criteria v4.0)
Toxicity measured and graded according to Common Terminology Criteria for Adverse Events v4.0 (CTCAE)
Grade refers to the severity of the adverse event. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline:
Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.
Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living.
Grade 3 Severe; medically significant but not immediately life-threatening; hospitalisation or prolongation of hospitalisation indicated; disabling or limiting self care activities of daily living.
Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
Measured: Up to 42 weeks
Number of Patients Experiencing a Laboratory Abnormality (Grade 3-4)
A laboratory abnormality is defined as an adverse event of grade 3 or 4 identified by a laboratory test of participant blood samples.
Adverse events were graded according to Common Terminology Criteria for Adverse Events v4.0 (CTCAE).
Measured: Up to 42 weeks
Disease Specific Overall Survival
Median time from death attributed to the disease. Censored at last known time alive or death from other causes.
Measured: Up to 42 weeks
Progression Free Survival
Time from randomisation for deemed non-resectable groups, or time from registration for deemed resectable group to first event, where an event is Progressive Disease as (defined by RECIST criterion v1.1) or death due to any cause. Patients who have not had an event will be censored at their last follow-up date. Patients lost to follow-up without an event will be censored at the date of their last consultation.
Progressive disease according to RECIST v1.1 is defined as a >=20% increase in the sum of long diameters of target lesions, OR progression of non-target lesions, OR evidence of new lesions.
Measured: Up to 42 weeks
Biological Response (Systemic Levels of Mifamurtide Activated Cytokines).
Biological response based on systemic levels of mifamurtide activated cytokines.
Measured: During screening, and weeks 1, 4, 6 and 7. Then every 3 weeks during treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startOct 2014
- Primary completion4 Nov 2016
- Study completion4 Nov 2016
Why it stopped: Failed to recruit sufficient numbers of patients in the funded period
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteosarcomaStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Millennium: The Takeda Oncology Company, National Institute for Health Research, United Kingdom, Oxford University Hospitals NHS Trust, European Commission
- Responsible party
- Sponsor
- Investigators
- Bass Hassan, BMBCh FRCP, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02441309
- Sponsor's protocol ID
- OCTO_039
- Acronym
- MEMOS
- Status last verified
- Mar 2018
- First submitted
- 16 Mar 2015
- Last updated
- 13 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mechanistic Study Of Mifamurtide (MTP-PE) In Patients With Metastatic And/Or Recurrent Osteosarcoma
- ClinicalTrials.gov ID
- NCT02441309
- Acronym / sponsor ID
- MEMOS / OCTO_039
- Conditions
- Osteosarcoma
- Keywords
- Metastatic and/or Recurrent Osteosarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failed to recruit sufficient numbers of patients in the funded period
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Millennium: The Takeda Oncology Company, National Institute for Health Research, United Kingdom, Oxford University Hospitals NHS Trust, European Commission
- Study start
- Oct 2014 (actual)
- Primary completion
- 4 Nov 2016 (actual)
- Study completion
- 4 Nov 2016 (actual)
- First posted
- 12 May 2015 (estimated)
- Results
- Posted 13 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Bayesian designed multi-arm, multi-centre, open label phase II study. The target sample size of 40 patients will be recruited from up to 8 EU countries, but this may be revised in light of the interim analysis. Patients with relapsed or metastatic osteosarcoma will be divided into three treatment groups. They will all either have surgery or a biopsy before and after six weeks exposure to either Mifamurtide alone, Ifosfamide alone, or Mifamurtide combined with Ifosfamide. They will then receive further treatment to a maximum of 42 or 36 weeks in total (depending on Arm), with all patients being able to receive 36 weeks of Mifamurtide treatment.
Detailed description
Osteosarcoma (OS) is the most common primary tumour arising from bones. There is currently no approved treatment other than surgery for metastatic or recurrent osteosarcoma refractory to chemotherapy. Patients deemed unresectable normally receive chemotherapy prior to attempted resection. The addition of chemotherapy to surgery for metastatic or recurrent osteosarcoma may improve response rates. MEPACT (Mifamurtide, MTP-PE) is licensed for use in the adjuvant osteosarcoma setting; indicated in children, adolescents and young adults for the treatment of high-grade resectable non-metastatic osteosarcoma after macroscopically complete surgical resection. It is used in combination with post-operative multi-agent chemotherapy. This is a Bayesian designed multi-arm, multi-centre open-label phase II study in patients with metastatic and/or recurrent osteosarcoma, which will investigate why some patients with osteosarcoma may respond better than others to mifamurtide given alone or in combination with ifosfamide. Patients with relapsed or metastatic osteosarcoma will be divided into three treatment groups (Arms). Depending on their current disease status, patients may be either Registered to Arm A (resectable group), to receive Mifamurtide alone; or Randomised to Arm B/C (non-resectable group), to receive mifamurtide in combination with ifosfamide. Arm A - Mifamurtide alone; Arm B - Ifosfamide alone for 6 weeks then Ifosfamide + mifamurtide for 6 weeks, then mifamurtide alone for 30 weeks; Arm C - Ifosfamide + mifamurtide for 12 weeks then mifamurtide alone for 24 weeks. All participants will receive 36 weeks or more of mifamurtide. Biopsies (or resected tumour samples) will be obtained before and after 6 weeks of therapy interval in order to determine the pharmacodynamic endpoints. The target sample size is 40 patients. An interim analysis will be performed for the primary efficacy endpoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A. Mifamurtide only | Experimental | Drug: MifamurtideTreatment Weeks 1-6 (post 1st biopsy/resection): Mifamurtide 2mg/m2, IV infusion, twice/week, with each infusion given at least 3 days apart, for 6 weeks. Treatment Weeks 7-12 (post 2nd biopsy/resection): Mifamurtide 2mg/m2, IV infusion, twice/week, with each infusion given at least 3 days apart, for 6 weeks. Treatment Weeks 13-36: Mifamurtide 2mg/m2, IV infusion, once/week. |
| B. Ifosfamide (Followed by Mifamurtide) | Experimental | Drug: Mifamurtide, Drug: IfosfamideTreatment Weeks 1-6: Day 1 of 21: Ifosfamide 12-15g/m2 IV infused over 4-5 days as per local practice. Repeated every 21 days for 2 cycles (3 weeks=1 cycle). Treatment Weeks 7-12 (post 2nd biopsy/resection): Day 1 of 21: Ifosfamide 12-15g/m2 IV infused over 4-5 days once every 21 days for two cycles (3 weeks=1 cycle). Ifosfamide administered as per local practice, including concurrent dosing with mesna. Plus mifamurtide 2mg/m2, IV infusion, twice/week. Ifosfamide infusion started 24 hours prior to mifamurtide. Mifamurtide given on day 2 and either day 5 or day 6. Treatment Weeks 13-18: Mifamurtide 2mg/m2, IV infusion, twice/week. Treatment Weeks 19-42: Mifamurtide 2mg/m2, IV infusion, once/week. |
| C. Ifosfamide + Mifamurtide | Experimental | Drug: Mifamurtide, Drug: IfosfamideTreatment Weeks 1-6: Day 1 of 21: Ifosfamide 12-15g/m2 IV infusion over 4-5 days once every 21 days for two cycles (3 weeks=1 cycle). Plus Mifamurtide 2mg/m2, IV infusion, twice per week, each given at least 3 days apart, for 6 weeks. Ifosfamide infusion started 24 hours prior to mifamurtide. Mifamurtide given on day 2 and either day 5 or day 6. Treatment Weeks 7-12 (post 2nd biopsy/resection): Day 1 of 21: Ifosfamide 12-15g/m2 IV infusion over 4-5 days once every 21 days for two cycles (3 weeks = 1 cycle). Plus Mifamurtide 2mg/m2, IV infusion, twice per week, given at least 3 days apart, for 6 weeks. Ifosfamide infusion started 24 hours prior to mifamurtide. Mifamurtide given on day 2 and either day 5 or day 6. Treatment Weeks 13-36: Mifamurtide 2mg/m2, IV infusion, once/week. |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (21 listed)
- Relapsed osteosarcoma (first, second, third or any relapse, patient has recovered from chemotherapy and any other investigational drug/agent treatment, radiotherapy or surgical procedure).
- Histological confirmed diagnosis of osteosarcoma at original presentation.
- Tumour at biopsy accessible or resectable site.
- Progressive disease documented by imaging within 3 months of entry into the trial.
- At least one measurable lesion on CT scan (RECIST) performed in past 21 days prior to trial entry.
Key exclusion criteria (14 listed)
- 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 (see section 5.1 Informed consent - Contraceptive/ Pregnancy counselling).
- 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.
- Contraindications to lung biopsies.
- Hypersensitivity to ifosfamide or any component of the formulation.
- Previously diagnosed brain metastases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mifamurtide | Drug | A. Mifamurtide only, B. Ifosfamide (Followed by Mifamurtide), C. Ifosfamide + Mifamurtide |
| Ifosfamide | Drug | B. Ifosfamide (Followed by Mifamurtide), C. Ifosfamide + Mifamurtide |
Primary outcome
Biological Response Data Based on Pharmacodynamic Endpoints on Tumour Biopsy Material
Time frame: Change from Baseline to after 6 weeks of treatment
Biological response data based on pharmacodynamic endpoints on tumour biopsy material including macrophage infiltration and innate immune activation.
Radiological Response Defined as Complete or Partial Response and Assessed Using RECIST Criteria
Time frame: Change from Baseline to after 6 weeks of treatment
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) assessed by CT or MRI: Complete Response (CR): Disappearance of all target and non-target lesions Partial Response (PR): >=30% decrease in the sum of the longest diameter of target lesions, AND no evidence of progression in non-target lesions, AND no new lesions Stable Disease (SD): sum of longest diameter of target lesions between PR and PD values, AND no evidence of progression in non-target lesions, AND no new lesions Progressive Disease (PD): >20% increase in the sum of the longest diameter of target lesions, OR evidence of progression in non-target lesions, OR evidence of new lesions
6 secondary outcomes
Objective Radiological Response Based on RECIST v1.1
Time frame: Change from Baseline to after 12, 18, 24 & 36 weeks and end of treatment visit
Number of Patients Experiencing a Grade 3 or More Severe Adverse Event (Graded According to CTCAE Criteria v4.0)
Time frame: Up to 42 weeks
Number of Patients Experiencing a Laboratory Abnormality (Grade 3-4)
Time frame: Up to 42 weeks
Disease Specific Overall Survival
Time frame: Up to 42 weeks
Progression Free Survival
Time frame: Up to 42 weeks
Biological Response (Systemic Levels of Mifamurtide Activated Cytokines).
Time frame: During screening, and weeks 1, 4, 6 and 7. Then every 3 weeks during treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bass Hassan, BMBCh FRCP principal investigator
University of Oxford
8 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mifamurtide and Ifosfamide in people with Osteosarcoma, run by University of Oxford at 8 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United Kingdom, Germany, Italy, Netherlands, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biological Response Data Based on Pharmacodynamic Endpoints on Tumour Biopsy Material (time frame: Change from Baseline to after 6 weeks of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2019.