About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Use of chronic steroids of other immunosuppressive agents
Pregnant or breast feeding
Trial design
Treatments tested in this trial
L-MTP-PE
DrugL-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.
Treatment groups
Trial outcomes
This trial has no outcomes listed.Sponsors and contacts
Click on the lead sponsor to view all of their trials.