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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Available

CT.gov ID

NCT04571229

Collaborator

(none)

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteosarcoma	Drug: L-MTP-PE

Study Design

Study Type:

Expanded Access

Official Title:

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

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