BIO-11006 for Osteosarcoma and Ewing's Sarcoma Lung Metastases
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- STATUS
- Recruiting
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- End date
- Nov 4, 2023
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- participants needed
- 10
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- sponsor
- Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Summary
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.
Description
This is a Phase 2, controlled study of BIO-11006 peptide given in addition to Gemcitabine and Docetaxel (GemTax) in the treatment of patients with advanced osteosarcoma or Ewing's sarcoma with lung metastases. Patients will receive BIO-11006 in addition to GemTax chemotherapy, which is a current institutional treatment option for recurrent Osteosarcoma and Ewings's Sarcoma. The BIO-11006 inhalation solution will be given by mouth inhalation twice daily. BIO-11006 will be given during the first three cycles and then will be stopped. Patients will continue on GemTax for up to 6 additional cycles and will be clinically assessed before every cycle and have standard-of-care imaging assessments after cycle 3, 6 and 9. 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. Subjects will be followed for disease status during routine clinical follow-ups for 9 months post the end of study treatment. The trial will be conducted at a single site.
Details
| Condition | Osteosarcoma Metastatic, Ewing's Sarcoma Metastatic |
|---|---|
| Treatment | Chemotherapy (gemcitabine & docetaxel) plus BIO-11006 |
| Clinical Study Identifier | NCT04183062 |
| Sponsor | Nicklaus Children's Hospital f/k/a Miami Children's Hospital |
| Last Modified on | 30 May 2022 |
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