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

NCT ID: NCT04571229

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: AVAILABLE
• Study Classification: EXPANDED_ACCESS

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

Interventions

L-MTP-PE

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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
• AST or ALT ≤ 3x upper limit of normal or ≤ 5x upper limit of normal for patients with liver metastases
• Willing to use a barrier method of contraception throughout the course of the study and for 1 year after participation if relevant

Exclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emily Slotkin, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Site Status: AVAILABLE

Countries

United States

Central Contacts

Emily Slotkin, MD

Role: CONTACT

slotkine@mskcc.org

212-639-8856

Paul Meyers, MD

Role: CONTACT

212-639-5952

Facility Contacts

Emily Slotkin, MD

Role: primary

212-639-8856

Paul Meyers, MD

Role: backup

212-639-5952

Related Links

http://www.mskcc.org/mskcc/html/44.cfm

Memorial Sloan Kettering Cancer Center

Other Identifiers

20-324

Identifier Type: -

Identifier Source: org_study_id