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

NCT00631631 | Completed

• 1 other identifier: MTP-OS-403
• Study Type: observational
• Target: 205
• Locations: 1 country
• Sites: 2

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).

Conditions

Osteosarcoma

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events

  12 months or disease progression, whichever occurs first

Secondary Outcomes (3)

• 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

• Overall survival

  From date of enrollment to date of death

• Progression-free survival

  From date of enrollment to date of first documented disease progression or death

Study Arms (1)

Mifamurtide (L-MTP-PE)

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.

Drug: Mifamurtide (L-MTP-PE)

Interventions

Mifamurtide (L-MTP-PE) DRUG

Solution for intravenous infusion

Also known as: Liposomal Muramyl Tripeptide Phosphatidyl Ethanolamine

Mifamurtide (L-MTP-PE)

Eligibility Criteria

• Age: 2 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

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.

Sponsors & Collaborators

• Millennium Pharmaceuticals, Inc.: lead

Study Sites (2)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Osteosarcoma

Interventions

mifamurtide

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Study Officials

• Peter M. Anderson, MD, PhD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2008
• First Posted: March 10, 2008
• Study Start: January 1, 2008
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: May 14, 2014

Record last verified: 2014-05

Locations

US (2)