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BIO-11006 + Chemotherapy for Sarcoma Lung Metastases

Phase 2

Waitlist Available

Led By Guillermo De Angulo, MD

Research Sponsored by Nicklaus Children's Hospital f/k/a Miami Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Recurrence within one year of end of previous therapy

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

Must not have

Any febrile illness or other severe illness within 2 weeks of enrollment

Current pneumonia or idiopathic pulmonary fibrosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 16 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing an investigational drug, BIO-11006, to see if it can help treat lung metastases in pediatric patients with advanced osteosarcoma or Ewing's sarcoma, by potentially enhancing the effect of chemotherapy.

Who is the study for?

This trial is for children and young adults aged 5-21 with lung metastases from osteosarcoma or Ewing's sarcoma, who can't have curative surgery. They must be able to take medication by nebulizer, not have certain blood disorders or severe liver issues, and agree to use effective contraception if applicable.

What is being tested?

The study tests BIO-11006 combined with chemotherapy (gemcitabine & docetaxel) in up to 10 patients at Nicklaus Children's Hospital. It aims to see if BIO-11006 improves the treatment of lung metastases from these cancers.

What are the potential side effects?

Possible side effects include those typical of chemotherapy like nausea, fatigue, hair loss, low blood cell counts leading to increased infection risk; plus any specific reactions related to the new drug BIO-11006.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer came back within a year after my last treatment ended.

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I am not pregnant and agree to use effective birth control during the study.

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I agree to use effective birth control methods if I can father a child.

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My cancer has spread to my lungs.

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I can use a nebulizer and will follow the BIO-11006 treatment plan.

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My cancer was confirmed as Ewing's sarcoma or osteosarcoma.

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My osteosarcoma cannot be treated with surgery aimed at curing it.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had a fever or severe illness in the last 2 weeks.

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I have pneumonia or a lung condition called idiopathic pulmonary fibrosis.

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My kidney function is reduced with a creatinine clearance below 45 mL/min.

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I have received an organ or bone marrow transplant.

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I cannot take gemcitabine or docetaxel due to adverse reactions.

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My bilirubin levels are higher than normal for my age.

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My cancer has worsened after treatment with gemcitabine and docetaxel.

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My cancer has spread to my brain or spinal cord.

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I have a history of HIV, hepatitis B, hepatitis C, or tuberculosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 16 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 16 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 16 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety - Treatment-emergent adverse events (TEAEs)

Secondary study objectives

Efficacy - Progression Free Survival (PFS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Chemotherapy plus BIO-11006Experimental Treatment1 Intervention

Patients will receive BIO-11006 in addition to GemTax chemotherapy. The BIO-11006 inhalation solution will be given by mouth inhalation twice daily. BIO-11006 will be given during the first three cycles of GemTax and then will be stopped. Subjects will continue with GemTax treatment for three additional cycles. 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.

0 / 16Eligibility criteria met