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

Sponsor: Memorial Sloan Kettering Cancer Center

Expanded Access
Sponsor score: 60

ClinicalTrials ID:NCT04571229

This expanded access protocol provides L-MTP-PE to osteosarcoma patients, activating white blood cells to target cancer. Eligible participants include those with confirmed osteosarcoma, adequate organ function, and a life expectancy over 6 weeks. Exclusions include chronic steroid use and pregnancy. L-MTP-PE is administered over 36 weeks, totaling 48 doses.

Patient Parameters

Program Overview

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 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

Locations

FACILITYZIPCITYSTATE
Memorial Sloan Kettering Cancer Center (All Protocol Activities)10065New YorkNew York

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