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Liposomal Muramyl Tripeptide Phosphatidyl Ethanolamine (L-MTP-PE): Compassionate Access for High-Risk Osteosarcoma
[Protocol 08-021]
- Full Title :
- LIPOSOMAL MURAMYL TRIPEPTIDE PHOSPHATIDYL ETHANOLAMINE (L-MTP-PE): COMPASSIONATE ACCESS FOR HIGH-RISK OSTEOSARCOMA
- Purpose :
The purpose of this study is to evaluate the safety and effectiveness of a drug called liposomal muramyl tripeptide phosphatidyl ethanolamine (L-MTP-PE) in patients with osteosarcoma that has a high risk of recurrence. Patients in this study are offered the drug on a compassionate use basis, which is a way to make a promising drug available to patients while it is still being evaluated.
Patients in this study will be given L-MTP-PE alone or combined with a recommended approved therapy for osteosarcoma. Studies have suggested that patients with osteosarcoma who received L-MTP-PE and chemotherapy fared better than those who received chemotherapy alone. Researchers want to study L-MTP-PE in a larger number of patients with osteosarcoma to see if it improves tumor response and survival.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have a confirmed diagnosis of osteosarcoma that is determined to be at high risk for recurrence. Patients must have relapsed or recurrent disease, locally or metastatic, with disease that is not completely resectable, or be unable to complete recommended chemotherapy due to side effects.
- Patients must not be confined to a bed or chair for more than half of their normal waking hours.
- Patients must be between the ages of 2 and 50 years old.
For more information and to inquire about eligibility for this study, please contact Dr. Paul Meyers at 212-639-5952.
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