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BIO-11006 + Chemotherapy for Sarcoma Lung Metastases
Study 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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You cannot have taken another experimental drug within 8 weeks before joining the study.You have been smoking or using tobacco within the past three months.My cancer came back within a year after my last treatment ended.I have not had a fever or severe illness in the last 2 weeks.I have pneumonia or a lung condition called idiopathic pulmonary fibrosis.I am not pregnant and agree to use effective birth control during the study.My kidney function is reduced with a creatinine clearance below 45 mL/min.I have received an organ or bone marrow transplant.I cannot take gemcitabine or docetaxel due to adverse reactions.I am taking medication that is mainly processed by liver enzymes.My bilirubin levels are higher than normal for my age.I agree to use effective birth control methods if I can father a child.You have had allergic reactions to the ingredients in BIO-11006.My cancer has spread to my lungs.I can use a nebulizer and will follow the BIO-11006 treatment plan.My cancer has worsened after treatment with gemcitabine and docetaxel.My cancer has spread to my brain or spinal cord.My cancer was confirmed as Ewing's sarcoma or osteosarcoma.I have a history of HIV, hepatitis B, hepatitis C, or tuberculosis.My osteosarcoma cannot be treated with surgery aimed at curing it.
- Group 1: Chemotherapy plus BIO-11006
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What therapeutic purpose is achieved by the combination of Chemotherapy (gemcitabine & docetaxel) plus BIO-11006?
"Chemotherapy (gemcitabine & docetaxel) plus BIO-11006 is widely employed to treat metastatic neoplasms, such as bladder cancer and urinary tract disorders. Additionally, it has been used in cases of advanced directives."
Is there still an opportunity to partake in this medical trial?
"As indicated on clinicaltrials.gov, this medical trial is not currently accepting participants; it was initially posted on October 4th 2019 and last updated November 8th 2022. Although the recruitment has halted for this study, there are 1849 other trials that have open enrolment at present."
Does this research include participants aged 50 and above?
"This clinical trial is seeking pediatric patients between the ages of 5-21. According to our records, there are currently 269 trials recruiting children under 18 and 1,701 actively enrolling adult patients over 65."
What eligibility requirements must participants meet for enrollment in this trial?
"In order to partake in this clinical trial, individuals must suffer from osteosarcoma and be between 5 and 21 years old. The researchers are seeking 10 willing participants for the study."
Has the combination of gemcitabine and docetaxel plus BIO-11006 gained authorization from the US Food & Drug Administration?
"Due to the experimental nature of this Phase 2 trial, our team at Power assigned a safety rating of 2. While some data exists on its security profile, there is no information yet regarding its efficacy."
Has there been any past research conducted on the combination of gemcitabine and docetaxel plus BIO-11006?
"Currently, there are 246 trials of Chemotherapy (gemcitabine & docetaxel) plus BIO-11006 in Phase 3 and 726 ongoing studies. Most of these investigations take place in Shanghai; however, 42091 medical sites across the world have been running tests on this combination therapy."
What is the highest number of participants enrolled in this experiment?
"At this moment, no individuals are being sought to participate in the study. Initially posted on October 4th 2019 and updated most recently on November 8th 2022, there are an abundance of alternate trials actively recruiting participants with osteosarcoma (1123) or Chemotherapy plus BIO-11006 (726)."
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