Mifamurtide (L-MTP-PE) for High-Risk Osteosarcoma

Osteosarcoma Clinical Trial

Official title:

Liposomal Muramyl Tripeptide Phosphatidyl Ethanolamine (L-MTP-PE) for High-risk Osteosarcoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00631631
• Other study ID #: MTP-OS-403
• Status: Completed
• Phase: N/A
• First received: February 29, 2008
• Last updated: May 13, 2014
• Start date: January 2008
• Est. completion date: October 2012

Study information

• Verified date: May 2014
• Source: Millennium Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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).

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 cancer.

This was a patient-access study that looked at adverse events, disease progression, and overall survival in study participants.

The study enrolled 205 patients, of whom 204 were treated with mifamurtide intravenously at a dose of 2 mg/m2 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 (following surgery for primary or metastatic disease).

This study was conducted in the United States. Participants could receive treatment for up to 9 months. This study was previously mis-categorized as an interventional study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 50 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteosarcoma

Intervention

Drug:
• Mifamurtide (L-MTP-PE)
Solution for intravenous infusion

Locations

Country	Name	City	State
United States	U.T.M.D. Anderson Cancer Center	Houston	Texas
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Millennium Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events		12 months or disease progression, whichever occurs first	Yes
Secondary	Serum concentration-time profiles of free and total mifamurtide in 15-20 patients		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	No
Secondary	Overall survival		From date of enrollment to date of death	No
Secondary	Progression-free survival		From date of enrollment to date of first documented disease progression or death	No