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

Phase

N/A

Condition

Osteosarcoma

Treatment

L-MTP-PE

Clinical Study ID

NCT04571229

20-324

All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Confirmed diagnosis of osteosarcoma of any age Note: Patients with either newlydiagnosed or relapsed osteosarcoma are eligible.
Surgical resection or other definitive local control therapy of all clinicallydetectable 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 ≥ 70mL/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 ageor ≤ 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 forpatients with liver metastases
Willing to use a barrier method of contraception throughout the course of the studyand for 1 year after participation if relevant

Exclusion

Exclusion Criteria:

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

Study Design