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

  • STATUS
    Recruiting
  • End date
    Nov 4, 2023
  • participants needed
    10
  • sponsor
    Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Updated on 30 May 2022

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 IdentifierNCT04183062
SponsorNicklaus Children's Hospital f/k/a Miami Children's Hospital
Last Modified on30 May 2022

Eligibility

Yes No Not Sure

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
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