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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-MTP-PE | Drug | 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:
Adequate renal function defined as:
Adequate liver function defined as:
Willing to use a barrier method of contraception throughout the course of the study and for 1 year after participation if relevant
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emily Slotkin, MD | Contact | 212-639-8856 | slotkine@mskcc.org | |
| Paul Meyers, MD | Contact | 212-639-5952 |
| Name | Affiliation | Role |
|---|---|---|
| Emily Slotkin, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | Available | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| ID | Term |
|---|---|
| D012516 | Osteosarcoma |
| ID | Term |
|---|---|
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C037144 | mifamurtide |
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| D009369 | Neoplasms |
| D012509 | Sarcoma |