Osteosarcoma
Conditions
Keywords
L-MTP-PE, Expanded Access, 20-324
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.
Interventions
DRUGL-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.
Sponsors
Memorial Sloan Kettering Cancer Center
Eligibility
Sex/Gender
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
Exclusion criteria
* Use of chronic steroids of other immunosuppressive agents * Pregnant or breast feeding
Countries
United States
Contacts
CONTACTEmily Slotkin, MD
CONTACTPaul Meyers, MD
PRINCIPAL_INVESTIGATOREmily Slotkin, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed