Clinical trial · Observational
Mifamurtide (L-MTP-PE) for High-Risk Osteosarcoma
Liposomal Muramyl Tripeptide Phosphatidyl Ethanolamine (L-MTP-PE) for High-risk Osteosarcoma
NCT00631631CI-TRIAL-00014522completedClinicalTrials.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)
The purpose of this study was to collect information regarding the safety and tolerability of mifamurtide (liposomal muramyl tripeptide phosphatidyl ethanolamine; L-MTP-PE).
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 (L-MTP-PE) | Drug | Mifamurtide | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Mifamurtide (L-MTP-PE)
- description
- Mifamurtide (L-MTP-PE), intravenous, at a dose of 2 mg/m\^2 twice weekly (at least 3 days apart) for 12 weeks, and then weekly for an additional 24 weeks, for a total of 48 doses in 36 weeks.
- interventionNames
- Drug: Mifamurtide (L-MTP-PE)
Primary outcomes (1)
- measure
- Number of participants with adverse events
- timeFrame
- 12 months or disease progression, whichever occurs first
Secondary outcomes (3)
- measure
- Serum concentration-time profiles of free and total mifamurtide in 15-20 patients
- timeFrame
- Just before the start of the first infusion of mifamurtide and at 0.5, 1, 2, 4, 6 and, 24 hours following the start of the first infusion and just prior to the 2nd dose of mifamurtide
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: 1. Had signed informed consent/assent. Voluntary participation in the pharmacokinetic portion of the compassionate access protocol was included in the informed consent but not required for compassionate use participation. 2. Had diagnosis of high grade osteosarcoma with relapsed or recurrent disease, locally or metastatic, with disease not completely resectable or who were unable to complete recommended chemotherapy due to toxicity: relapse, recurrence local or metastatic; unable to have standard surgical resection; abbreviated chemotherapy regimen secondary to toxicity (e.g. hypophosphatemia from ifosfamide, cardiotoxicity from doxorubicin, renal dysfunction from methotrexate, ifosfamide, or cisplatin.) 3. Aged 2 ≤ 50 years. 4. Had adequate hematopoietic function as demonstrated by: 1) Absolute Neutrophil Count (ANC) \> 750/microL; Hemoglobin (Hb) \> 8 g/dL; Platelets \> 30,000/microL. 5. Had adequate hepatic function as documented by 1) ALT \< 2.5 x upper limit of normal (ULN) for age; 2) total bilirubin ≤ 1.5 x ULN for age. 6. Had adequate renal function as demonstrated by: 1) Creatinine clearance or radioisotope glomerular filtration rate \> 70 mL/min/1.73 m\^2; OR, 2) Serum creatinine ≤ 2x ULN for age. 7. Had absence of concurrent active acute infection (i.e., afebrile). 8. In females of child bearing potential (not menopausal for 12 months or no previous surgical sterilization), had a negative pregnancy test. All sexually active participants used an effective means of contraception. Such means included oral contraceptives, Lupron Depot, DepoProvera, and condom with diaphragm and spermicidal jelly. 9. Performance status: Lansky 50-100% (≤ 16 years of age); OR, Eastern Cooperative Oncology Group (ECOG) 0-2 or Karnofsky 50-100% (\>16 years of age). Exclusion Criteria: 1. Had chronic use of corticosteroids or other immunosuppressive agents. 2. Was pregnant or breast-feeding.
References
Publications (0)
Data not yet available
No reference posted for this study.