Status:
COMPLETED
Mifamurtide (L-MTP-PE) for High-Risk Osteosarcoma
Lead Sponsor:
Millennium Pharmaceuticals, Inc.
Conditions:
Osteosarcoma
Eligibility:
All Genders
2-50 years
Brief Summary
The purpose of this study was to collect information regarding the safety and tolerability of mifamurtide (liposomal muramyl tripeptide phosphatidyl ethanolamine; L-MTP-PE).
Detailed Description
The drug being tested in this study is called mifamurtide (L-MTP-PE; liposomal muramyl tripeptide phosphatidyl ethanolamine). Mifamurtide is being used to treat people with osteosarcoma, a form of can...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- Had chronic use of corticosteroids or other immunosuppressive agents.
- Was pregnant or breast-feeding.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
205 Patients enrolled
Trial Details
Trial ID
NCT00631631
Start Date
January 1 2008
End Date
October 1 2012
Last Update
May 14 2014
Active Locations (2)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
2
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030