BIO-11006 for Osteosarcoma and Ewing's Sarcoma Lung Metastases

• Status: Recruiting
• Trial end date: 2023-11-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nicklaus Children's Hospital f/k/a Miami Children's Hospital
• Treatments: Docetaxel; Gemcitabine

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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