Mifamurtide (L-MTP-PE) for High-Risk Osteosarcoma
Completed
Conditions studied: Osteosarcoma
In brief
The purpose of this study was to collect information regarding the safety and tolerability of mifamurtide (liposomal muramyl tripeptide phosphatidyl ethanolamine; L-MTP-PE).
Key facts
- Study ID
- NCT00631631
- Run by
- Millennium Pharmaceuticals, Inc.
- People needed
- 205
- Starts
- 2008-01-01
- Expected to finish
- 2012-10-01
- Last updated by the study team
- 2014-05-14
Who can join
Age: 2 and older, up to 50. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
- 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.)
- Aged 2 ≤ 50 years.
- Had adequate hematopoietic function as demonstrated by: 1) Absolute Neutrophil Count (ANC) > 750/microL; Hemoglobin (Hb) > 8 g/dL; Platelets > 30,000/microL.
- 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.
- 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.
- Had absence of concurrent active acute infection (i.e., afebrile).
- 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.
- 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).
You may not qualify if…
- Had chronic use of corticosteroids or other immunosuppressive agents.
- Was pregnant or breast-feeding.
Where it is running
- Memorial Sloan-Kettering Cancer Center — New York, New York, United States
- U.T.M.D. Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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