OsteosarcomaNCT01194284
Surveillance Study of Patients With Newly Diagnosed Osteosarcoma
An observational study of Osteosarcoma, run by Millennium Pharmaceuticals, Inc. at 1 site in Austria.
Trial summary
This study is an observational safety surveillance study designed to prospectively assess patients with high-grade osteosarcoma who are candidates for treatment with mifamurtide within the context of prevailing standard oncology practice Read more about this study
- Who is it for?
- Ages 2 to 40 years
- Conditions the study is for
- Osteosarcoma
- What is being tested?
- Mifamurtide
- How many people
- 25 participants
- Where
- 1 siteAustria
- Study dates
- Dec 2011to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
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 2 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study population consists of patients with high-grade osteosarcoma who are candidates for treatment with mifamurtide within the context of prevailing standard oncology practice.
Who may be able to join
- Each patient must meet all of the following inclusion criteria to be enrolled in the study:
- Male or female aged 2 to 40 years
- Confirmed pathological diagnosis of newly-diagnosed, nonmetastatic, resectable, primary, high-grade osteosarcoma
- Have completed definitive surgery (or other local ablation technique)
- Have a treatment regimen that includes mifamurtide and a minimum of 2 recognized chemotherapy agents in the treatment of osteosarcoma (cisplatin, doxorubicin, high-dose methotrexate or ifosfamide)
- Organ function deemed satisfactory to receive planned chemotherapy containing at minimum 2 of the recognized chemotherapy agents in the treatment of osteosarcoma
- Voluntary Written Consent
Who cannot join
- Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
- Female patients who are lactating and breastfeeding or have a positive serum pregnancy test during the screening period
- History of pericarditis or pleuritis
- Have low-grade osteosarcoma or parosteal or periosteal sarcoma
- Have osteosarcoma associated with Paget's disease
- Current treatment with any anticancer investigational products at the time of enrollment in this study
Trial locations and contacts
1 site in 1 country.
Austria1 site
AKH Wien Universitätsklinik für Innere Medizin I Klinische Abteilung für Onkologie
Vienna
About this study
Official title: Observational, Noninterventional Surveillance Study of Patients With Newly Diagnosed Osteosarcoma
This study is an observational safety surveillance study designed to prospectively assess patients with high-grade osteosarcoma who are candidates for treatment with mifamurtide within the context of prevailing standard oncology practice
- Conditions
- Osteosarcoma
- Being tested
- Mifamurtide
- Medical subject headings
- Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MifamurtideDrug
Also called MEPACT
Mifamurtide will be prescribed to patients with high-grade osteosarcoma as part of their treatment regimen within the context of prevailing standard oncology practice. The recommended dose of mifamurtide is 2 mg/m2. Mifamurtide will be administered for 36 weeks as adjuvant therapy following surgical resection.
| Study group | Role | What they receive |
|---|---|---|
| High-grade osteosarcoma patients | Not described Receives: Drug: Mifamurtide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term safety profile of mifamurtide during treatment (mifamurtide in combination with chemotherapy)
- Adverse events of special interest (AESIs), including important identified and potential risks
- The frequency and pattern of mifamurtide-related infusion adverse events
Measured: 36 weeks
The long-term safety profile of mifamurtide during and following treatment (mifamurtide in combination with chemotherapy)
Assessment of AESIs, consisting of important identified and potential risks
Measured: Up to 5 years from the last dose of mifamurtide or until death
Secondary outcomes (2)
Disease-free survival
Measured: Up to 5 years from the last dose of mifamurtide or until death
Overall Survival
Measured: Up to 5 years from the last dose of mifamurtide or until death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2010 (estimated)
- Study startDec 2011
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: Regulatory agency commitment fulfilled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteosarcomaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Millennium Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01194284
- Sponsor's protocol ID
- C23003
- Other IDs
- 2009-017204-89, 2009
- Status last verified
- Jan 2017
- First submitted
- 1 Sep 2010
- Last updated
- 19 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational, Noninterventional Surveillance Study of Patients With Newly Diagnosed Osteosarcoma
- ClinicalTrials.gov ID
- NCT01194284
- Acronym / sponsor ID
- C23003
- Conditions
- Osteosarcoma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Regulatory agency commitment fulfilled.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 2 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an observational safety surveillance study designed to prospectively assess patients with high-grade osteosarcoma who are candidates for treatment with mifamurtide within the context of prevailing standard oncology practice
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-grade osteosarcoma patients | – | Drug: Mifamurtide |
Who may qualify
- Ages
- 2 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population consists of patients with high-grade osteosarcoma who are candidates for treatment with mifamurtide within the context of prevailing standard oncology practice.
Key inclusion criteria (7 listed)
- Each patient must meet all of the following inclusion criteria to be enrolled in the study:
- Male or female aged 2 to 40 years
- Confirmed pathological diagnosis of newly-diagnosed, nonmetastatic, resectable, primary, high-grade osteosarcoma
- Have completed definitive surgery (or other local ablation technique)
- Have a treatment regimen that includes mifamurtide and a minimum of 2 recognized chemotherapy agents in the treatment of osteosarcoma (cisplatin, doxorubicin, high-dose methotrexate or ifosfamide)
Key exclusion criteria (6 listed)
- Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
- Female patients who are lactating and breastfeeding or have a positive serum pregnancy test during the screening period
- History of pericarditis or pleuritis
- Have low-grade osteosarcoma or parosteal or periosteal sarcoma
- Have osteosarcoma associated with Paget's disease
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 |
|---|---|---|
| MifamurtideAlso: MEPACTMifamurtide will be prescribed to patients with high-grade osteosarcoma as part of their treatment regimen within the context of prevailing standard oncology practice. The recommended dose of mifamurtide is 2 mg/m2. Mifamurtide will be administered for 36 weeks as adjuvant therapy following surgical resection. | Drug | High-grade osteosarcoma patients |
Primary outcome
Short-term safety profile of mifamurtide during treatment (mifamurtide in combination with chemotherapy)
Time frame: 36 weeks
* Adverse events of special interest (AESIs), including important identified and potential risks * The frequency and pattern of mifamurtide-related infusion adverse events
The long-term safety profile of mifamurtide during and following treatment (mifamurtide in combination with chemotherapy)
Time frame: Up to 5 years from the last dose of mifamurtide or until death
Assessment of AESIs, consisting of important identified and potential risks
2 secondary outcomes
Disease-free survival
Time frame: Up to 5 years from the last dose of mifamurtide or until death
Overall Survival
Time frame: Up to 5 years from the last dose of mifamurtide or until death
Results and safety
The study was stopped early (reason given: Regulatory agency commitment fulfilled.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2017.
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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.
Medical Monitor study director
Millennium Pharmaceuticals, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteosarcoma, run by Millennium Pharmaceuticals, Inc. at 1 site in Austria.
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 7 inclusion and 6 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 19 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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.
Are results available for this study?
The study was stopped early (reason given: Regulatory agency commitment fulfilled.). Results are not available in the source record.
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?
Short-term safety profile of mifamurtide during treatment (mifamurtide in combination with chemotherapy) (time frame: 36 weeks). 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 19 Jan 2017.