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

Osteosarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Available

Administrative data

• NCT number: NCT04571229
• Other study ID #: 20-324
• Status: Available

Study information

• Verified date: May 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Emily Slotkin, MD
• Phone: 212-639-8856
• Email: slotkine[@]mskcc.org
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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.

Recruitment information / eligibility

• Status: Available
• Enrollment: 0
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Osteosarcoma

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

External Links

•   Memorial Sloan Kettering Cancer Center