BIO-11006 for Osteosarcoma and Ewing's Sarcoma Lung Metastases
This is a Phase 2 study of an investigational drug, BIO-11006, for the treatment of lung metastases in pediatric patients with advanced osteosarcoma or Ewing's sarcoma. This study will enroll up to 10 patients aged between 5 and 21 at Nicklaus Children's Hospital in Miami, FL. Patients will receive BIO-11006 in addition to chemotherapy consisting of gemcitabine and docetaxel. This study will test the hypothesis that BIO-11006 will enhance the effect of the gemcitabine and docetaxel chemotherapy to treat lung metastases in osteosarcoma and Ewing's sarcoma.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
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These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Nov 8, 2024 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Nicklaus Children's Hospital f/k/a Miami Children's Hospital
- Interventions being studied
- Drug: Chemotherapy (gemcitabine & docetaxel) plus BIO-11006
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
1. Histologic verification of Ewing's sarcoma or osteosarcoma at original diagnosis or at relapse 2. Recurrence within one year of end of previous therapy 3. Presence of lung metastases 4. Osteosarcoma patients must be ineligible for curative surgery 5. Ability to take inhaled medication by nebulizer and be willing to adhere to the BIO-11006 regimen 6. 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. 7. Males of reproductive potential must agree to the use of condoms or other methods to ensure effective contraception with partner 8. Stated willingness to comply with all study procedures and availability for the duration of the study 9. Provision of signed and dated informed consent form
1. Previously treated and progressed on gemcitabine and docetaxel 2. Central Nervous System (CNS) metastases 3. Contraindication to gemcitabine or docetaxel 4. Known allergic reactions to components of BIO-11006 5. Use of medications that are primarily metabolized by cytochrome P450 isoenzymes 6. Treatment with another investigational drug within 8 weeks of enrollment. 7. Current pneumonia or idiopathic pulmonary fibrosis 8. Absolute Neutrophil Count (ANC) \< 750 cells/mm3 9. Platelet count \< 75,000 cells/mm3 10. Hemoglobin \<8.0 g/dL 11. Creatinine clearance (CrCL) \< 45 mL/min 12. Bilirubin \> upper limit of normal (ULN) for age 13. AST and/or ALT \>1.5 x ULN concomitant with alkaline phosphatase \>2.5 x ULN 14. Organ transplant or bone marrow transplant recipient 15. Pregnancy or lactation 16. Current smoker or tobacco use within 3 months prior to enrollment 17. Any febrile illness or other severe illness within 2 weeks of enrollment 18. Known history of human immunodeficiency virus, hepatitis B, hepatitis C or tuberculosis
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Nicklaus Children's HospitalMiami, Florida
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 8, 2024. Always confirm current availability with the study team.