Clinical trial · Expanded Access
Expanded Access Use of L-MTP-PE for the Treatment of Osteosarcoma
NCT04571229CI-TRIAL-00111094availableClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This expanded access protocol will allow access to treatment with L-MTP-PE for people with osteosarcoma. L-MTP-PE is an investigational drug that has not been approved by the FDA to treat any condition, including osteosarcoma. L-MTP-PE works by activating certain types of white blood cells, and these active white blood cells help the immune system kill cancer cells.
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 |
|---|---|---|---|
| L-MTP-PE | Drug | Mifamurtide | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Confirmed diagnosis of osteosarcoma of any age Note: Patients with either newly diagnosed or relapsed osteosarcoma are eligible. * Surgical resection or other definitive local control therapy of all clinically detectable sites of osteosarcoma * L-MTP-PE is deemed to be of potential benefit by the treating investigator * Willing and able to understand and sign informed consent and assent as appropriate * Life expectancy \> 6 weeks * Adequate organ function as follows: * Adequate bone marrow function defined as: * absolute neutrophil count (ANC) ≥ 750/mm\^3 * platelet count ≥ 30,000/ mm\^3 * hemoglobin ≥ 8 g/dl * Adequate renal function defined as: * Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min/1.73m\^2 OR * Serum creatinine ≤ 2x the upper limit of normal based on age/gender * Adequate liver function defined as: * Bilirubin (sum of conjugated + unconjugated) ≤ 2x upper limit of normal for age or ≤ 4x upper limit of normal if thought to have Gilbert's disease * AST or ALT ≤ 3x upper limit of normal or ≤ 5x upper limit of normal for patients with liver metastases * Willing to use a barrier method of contraception throughout the course of the study and for 1 year after participation if relevant Exclusion Criteria: * Use of chronic steroids of other immunosuppressive agents * Pregnant or breast feeding
References
Publications (0)
Data not yet available
No reference posted for this study.