Ewing's Sarcoma Metastatic Clinical Trial
Official title:
A Phase 2 Study of the Safety and Efficacy of BIO-11006 in the Treatment of Recurrent Osteosarcoma and Ewing's Sarcoma in Patients With Lung Metastases
Verified date | November 2022 |
Source | Nicklaus Children's Hospital f/k/a Miami Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 10 |
Est. completion date | November 4, 2024 |
Est. primary completion date | November 4, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 21 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Nicklaus Children's Hospital | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
Nicklaus Children's Hospital f/k/a Miami Children's Hospital |
United States,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety - Treatment-emergent adverse events (TEAEs) | Frequency, type, severity, and duration of TEAEs. Sources of TEAEs may include spontaneous patient reports, results of physical examinations, and clinical laboratory measurements. Simple descriptive statistics of frequencies, centrality and variability will be utilized to tabulate and summarize TEAEs. If sufficient number of TEAEs will be captured, frequencies, duration and severity will be compared. | Up to 16 months | |
Secondary | Efficacy - Progression Free Survival (PFS) | PFS will be measured from Cycle 1 Day 1 until occurrence of event (such as death, disease progression or end of study). | Up to 16 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
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