Expanded Access Use of L-MTP-PE for the Treatment of Osteosarcoma

NCT04571229 | Unknown

• 1 other identifier: 20-324
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This expanded access protocol will allow access to treatment with L-MTP-PE for people with osteosarcoma. L-MTP-PE is an investigational drug that has not been approved by the FDA to treat any condition, including osteosarcoma. L-MTP-PE works by activating certain types of white blood cells, and these active white blood cells help the immune system kill cancer cells.

Conditions

Osteosarcoma

Keywords

L-MTP-PE; Expanded Access; 20-324

Interventions

L-MTP-PE DRUG

L-MTP-PE will be administered at a dose of 2mg/m2 (maximum dose 4 mg), twice weekly for 12 weeks and weekly for an additional 24 weeks, for a total of 48 doses in 36 weeks.

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of osteosarcoma of any age Note: Patients with either newly diagnosed or relapsed osteosarcoma are eligible.
• Surgical resection or other definitive local control therapy of all clinically detectable sites of osteosarcoma
• L-MTP-PE is deemed to be of potential benefit by the treating investigator
• Willing and able to understand and sign informed consent and assent as appropriate
• Life expectancy \> 6 weeks
• Adequate organ function as follows:
• Adequate bone marrow function defined as:
• absolute neutrophil count (ANC) ≥ 750/mm\^3
• platelet count ≥ 30,000/ mm\^3
• hemoglobin ≥ 8 g/dl
• Adequate renal function defined as:
• Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min/1.73m\^2 OR
• Serum creatinine ≤ 2x the upper limit of normal based on age/gender
• Adequate liver function defined as:
• Bilirubin (sum of conjugated + unconjugated) ≤ 2x upper limit of normal for age or ≤ 4x upper limit of normal if thought to have Gilbert's disease

You may not qualify if:

• Use of chronic steroids of other immunosuppressive agents
• Pregnant or breast feeding

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

AVAILABLE

Related Links

• Memorial Sloan Kettering Cancer Center

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

• Emily Slotkin, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily Slotkin, MD

CONTACT

212-639-8856; slotkine@mskcc.org

Paul Meyers, MD

CONTACT

212-639-5952

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: September 30, 2020
• Last Updated: May 11, 2026

Record last verified: 2026-05

Locations

US (1)