BIO-11006 for Osteosarcoma and Ewing's Sarcoma Lung Metastases
Osteosarcoma Metastatic, Ewing's Sarcoma Metastatic
About this trial
This is an interventional treatment trial for Osteosarcoma Metastatic focused on measuring bone cancer, sarcoma, lung metastases, pediatric cancers
Eligibility Criteria
Inclusion Criteria:
- Histologic verification of Ewing's sarcoma or osteosarcoma at original diagnosis or at relapse
- Recurrence within one year of end of previous therapy
- Presence of lung metastases
- Osteosarcoma patients must be ineligible for curative surgery
- Ability to take inhaled medication by nebulizer and be willing to adhere to the BIO-11006 regimen
- Females of reproductive potential must have a negative pregnancy test at screening and must agree to use a method of highly effective contraception during study participation.
- Males of reproductive potential must agree to the use of condoms or other methods to ensure effective contraception with partner
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Provision of signed and dated informed consent form
Exclusion Criteria:
- Previously treated and progressed on gemcitabine and docetaxel
- Central Nervous System (CNS) metastases
- Contraindication to gemcitabine or docetaxel
- Known allergic reactions to components of BIO-11006
- Use of medications that are primarily metabolized by cytochrome P450 isoenzymes
- Treatment with another investigational drug within 8 weeks of enrollment.
- Current pneumonia or idiopathic pulmonary fibrosis
- Absolute Neutrophil Count (ANC) < 750 cells/mm3
- Platelet count < 75,000 cells/mm3
- Hemoglobin <8.0 g/dL
- Creatinine clearance (CrCL) < 45 mL/min
- Bilirubin > upper limit of normal (ULN) for age
- AST and/or ALT >1.5 x ULN concomitant with alkaline phosphatase >2.5 x ULN
- Organ transplant or bone marrow transplant recipient
- Pregnancy or lactation
- Current smoker or tobacco use within 3 months prior to enrollment
- Any febrile illness or other severe illness within 2 weeks of enrollment
- Known history of human immunodeficiency virus, hepatitis B, hepatitis C or tuberculosis
Sites / Locations
- Nicklaus Children's Hospital
Arms of the Study
Arm 1
Experimental
Chemotherapy plus BIO-11006
Patients will receive BIO-11006 in addition to GemTax chemotherapy. The BIO-11006 inhalation solution will be given by mouth inhalation twice daily. BIO-11006 will be given during the first three cycles of GemTax and then will be stopped. Subjects will continue with GemTax treatment for three additional cycles. If the patient shows lung progression (either clinical or on imaging) at any point after cycle 4 has been given, but had shown at least a partial response during the tumor assessment after cycle 3, BIO-11006 may be re-started at the discretion of the investigator and continued for the duration of the GemTax treatment.