Clinical trial · Observational
Surveillance Study of Patients With Newly Diagnosed Osteosarcoma
Observational, Noninterventional Surveillance Study of Patients With Newly Diagnosed Osteosarcoma
NCT01194284CI-TRIAL-00025530terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Regulatory agency commitment fulfilled.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Osteosarcoma | Osteosarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mifamurtide | Drug | Mifamurtide | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- High-grade osteosarcoma patients
- interventionNames
- Drug: Mifamurtide
Primary outcomes (2)
- measure
- Short-term safety profile of mifamurtide during treatment (mifamurtide in combination with chemotherapy)
- timeFrame
- 36 weeks
- description
- * Adverse events of special interest (AESIs), including important identified and potential risks * The frequency and pattern of mifamurtide-related infusion adverse events
- measure
- The long-term safety profile of mifamurtide during and following treatment (mifamurtide in combination with chemotherapy)
- timeFrame
- Up to 5 years from the last dose of mifamurtide or until death
- description
- Assessment of AESIs, consisting of important identified and potential risks
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria 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 Exclusion Criteria 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
References
Publications (0)
Data not yet available
No reference posted for this study.