A Mechanistic Study Of Mifamurtide (MTPPE) In Patients With Metastatic And/Or Recurrent Osteosarcoma
| ISRCTN | ISRCTN82138287 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82138287 |
| EudraCT/CTIS number | 2012-000615-84 |
| ClinicalTrials.gov number | NCT02441309 |
| Secondary identifying numbers | 16801 |
- Submission date
- 18/09/2014
- Registration date
- 18/09/2014
- Last edited
- 11/06/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Ms Linda Collins
Scientific
Scientific
Oncology Clinical Trials Office (OCTO) - Department of Oncology
Old Road Campus
Roosevelt Drive
Headington
Oxford
OX3 7DQ
United Kingdom
| Phone | +44 (0)1865 227162 |
|---|---|
| octo-eurosarc@oncology.ox.ac.uk |
Study information
| Study design | Both; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A Mechanistic Study Of Mifamurtide (MTPPE) In Patients With Metastatic And/Or Recurrent Osteosarcoma |
| Study acronym | MEMOS: a Eurosarc Study of Mifamurtide in advanced osteosarcoma |
| Study objectives | 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. |
| Ethics approval(s) | South Central - Oxford C Research Ethics Committee, 13/06/2014, ref: 14/SC/0255 |
| Health condition(s) or problem(s) studied | Topic: Cancer; Subtopic: Sarcoma; Disease: Bone |
| Intervention | 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Mifamurtide, Ifosfamide |
| Primary outcome measure | Objective Radiological response; Timepoint(s): Pre-treatment, after 6, 12, 18, 24 & 36 weeks of treatment |
| Secondary outcome measures | 1. Biological response; Timepoint(s): Pre-treatment and after 6 weeks of treatment 2. Disease specific overall survival; Timepoint(s): End of trial 3. Progression free survival on serial CT scan; Timepoint(s): Pre-treatment, after 6, 12, 18, 24 and 36 of weeks of treatment 4. Safety and tolerability on CTCAE Criteria (v4.0); Timepoint(s): Throughout trial treatment |
| Overall study start date | 12/09/2014 |
| Completion date | 11/03/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 40; UK Sample Size: 10 |
| Key inclusion criteria | 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 |
| Key exclusion criteria | 1. Pregnant or breastfeeding 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 nonsteroidal antiinflammatory 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 conebiopsied 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. |
| Date of first enrolment | 12/09/2014 |
| Date of final enrolment | 11/03/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Oncology Clinical Trials Office (OCTO)
Oxford
OX3 7DQ
United Kingdom
OX3 7DQ
United Kingdom
Sponsor information
University of Oxford (UK)
University/education
University/education
Wellcome Trust Centre for Human Genetics
Oxford
OX3 7BN
England
United Kingdom
"ROR" |
https://ror.org/052gg0110 |
|---|
Funders
Funder type
Government
European Commission
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- European Union, Comisión Europea, Europäische Kommission, EU-Kommissionen, Euroopa Komisjoni, Ευρωπαϊκής Επιτροπής, Европейската комисия, Evropské komise, Commission européenne, Choimisiúin Eorpaigh, Europskoj komisiji, Commissione europea, La Commissione europea, Eiropas Komisiju, Europos Komisijos, Európai Bizottságról, Europese Commissie, Komisja Europejska, Comissão Europeia, Comisia Europeană, Európskej komisii, Evropski komisiji, Euroopan komission, Europeiska kommissionen, EC, EU
Millenium Pharmaceuticals Inc. (USA)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No | |||
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
11/06/2019: Publication and dissemination plan and IPD sharing statement added, contact details updated.
07/06/2019: No publications found. Verifying results with principal investigator.
15/05/2018: Link to basic results added.
