This expanded access protocol will allow access to treatment with L-MTP-PE for peoplewith osteosarcoma. L-MTP-PE is an investigational drug that has not been approved by theFDA to treat any condition, including osteosarcoma. L-MTP-PE works by activating certaintypes of white blood cells, and these active white blood cells help the immune systemkill cancer cells.
Not Provided
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.
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
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States
Investigator: Emily Slotkin, MD
Contact: 212-639-8856
Investigator: Emily Slotkin, MD
Emily Slotkin, MD
212-639-8856
slotkine@mskcc.org
Paul Meyers, MD
212-639-5952
Emily Slotkin, MD, Principal Investigator
Memorial Sloan Kettering Cancer Center