Chemotherapy (gemcitabine & docetaxel) plus BIO-11006 for Osteosarcoma

1 Prior Treatment
Locally Advanced
Recruiting · < 65 · All Sexes · Miami, FL

This study is evaluating whether a drug may help treat lung metastases in children with cancer.

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About the trial for Osteosarcoma

Eligible Conditions
Sarcoma · Osteosarcoma · Sarcoma, Ewing · Ewing's Sarcoma Metastatic · Neoplasm Metastasis · Osteosarcoma Metastatic

Treatment Groups

This trial involves 2 different treatments. Chemotherapy (gemcitabine & Docetaxel) Plus BIO-11006 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Chemotherapy (gemcitabine & docetaxel) plus BIO-11006
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.


This trial is for patients born any sex aged 65 and younger. You must have received 1 prior treatment for Osteosarcoma or one of the other 5 conditions listed above. There are 9 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The patient will be able to take inhaled medication by nebulizer and be willing to adhere to the BIO-11006 regimen. show original
A woman who could possibly become pregnant must have a negative pregnancy test before participating in the study, and must agree to use a highly effective method of contraception during the study. show original
to participate in study The researcher will provide a signed and dated form, which will act as an informed consent document, to any individual who wishes to participate in the study show original
Men who could potentially father a child must agree to use condoms or other contraceptive methods to ensure the child will not be born. show original
Osteosarcoma patients who are not eligible for surgery that could cure their cancer are typically treated with chemotherapy. show original
is essential for accurate staging, treatment planning, and assessment of therapeutic response show original
for Helicobacter pylori There is a high chance that a person will experience a recurrence of Helicobacter pylori infection within one year of ending previous therapy. show original
Presence of lung metastases
I am willing to comply with all study procedures and be available for the duration of the study. show original
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Odds of Eligibility
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 16 months
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 16 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 16 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Chemotherapy (gemcitabine & docetaxel) plus BIO-11006 will improve 1 primary outcome and 1 secondary outcome in patients with Osteosarcoma. Measurement will happen over the course of Up to 16 months.

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).
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.

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is osteosarcoma?

These pediatric tumors are very rare. Most patients are 2- or 25-years-old, and the majority are male. The most common site of primary growth is the proximal femur (about 70% of cases), and this is most commonly seen in early stage disease. Osteosarcoma occurs most commonly in the distal femur and proximal tibia. Primary tumors have been identified as arising within the skeleton or soft tissue with the most common location being the lower extremity. Osteosarcoma is diagnosed on histological examination of bone marrow aspirates and can be categorized according to several diagnostic criteria.

Anonymous Patient Answer

What causes osteosarcoma?

A number of genetic, environmental, and lifestyle factors have been suggested as the cause of OS. However, the primary etiologic mechanisms are not well understood. This lack of progress should be considered in developing preventive strategies.

Anonymous Patient Answer

How many people get osteosarcoma a year in the United States?

Approximately 3,400 children and adolescents are diagnosed with osteosarcoma, making it the third most common cancer of youths, after leukemia and soft tissue sarcomas. Osteosarcoma can occur in any age group, but it rarely occurs before age 10 or after age 25. Approximately 60% of cases occur in the extremities and pelvis. In children, the likelihood of osteosarcoma increasing with age was seen in a log-log analysis. Most osteosarcomas in children and adolescents are high-grade and locally advanced at presentation. The disease is most common in Caucasians, with about 60% of osteosarcoma cases in whites.

Anonymous Patient Answer

Can osteosarcoma be cured?

There is an ongoing debate as to whether osteosarcoma can be cured and whether this means that, in an individual person, the disease can be extinguished over time or that the'symptoms' which seem 'cured' are actually only a result. With more research, we may be able to answer both these questions. In a recent study, findings confirm that at least some cases are cured and that, where such cures have occurred, the process has occurred at the level of a single clone of somatic cells.

Anonymous Patient Answer

What are common treatments for osteosarcoma?

The majority of patients diagnosed with osteosarcoma receive multimodal treatment. Survival rates have improved in recent decades, but with the advent of new cancer biology understanding, there is a new focus on targeted therapies.

Anonymous Patient Answer

What are the signs of osteosarcoma?

A palpable mass is the main symptom (77%). However, it is not always the main sign of this cancer. Pain, especially in the knee, or shoulder, may be painful symptoms (26%).

Anonymous Patient Answer

How does chemotherapy (gemcitabine & docetaxel) plus bio-11006 work?

The efficacy of bio-11006 in combination with standard chemotherapy (Gemcitabine plus Docetaxel) could not be shown with the current study design. This should be considered when investigating clinical effects.

Anonymous Patient Answer

What are the latest developments in chemotherapy (gemcitabine & docetaxel) plus bio-11006 for therapeutic use?

Gemcitabine and bio-11006 are both cytotoxic chemotherapies that appear to have a significant effect on the treatment of osteosarcoma. However, further work needs to be done to determine the optimum schedule of administration and the optimal dosing of bio-11006.

Anonymous Patient Answer

How serious can osteosarcoma be?

There is now sufficient evidence of a significantly improving overall survival of patients with osteosarcoma. This progress is at least in part due to advancements in treatment including earlier diagnosis and improved surgical resection of disease. Given the extremely poor cure rate (10–20%) associated with most malignancies, such improved overall survival will result in a substantial improvement in quality of life for survivors and their families. Survival is certainly a significant goal for treatment guidelines. However survival remains far short of cure; cure is defined as 'the end of disease'. Therefore, cure is an elusive goal for many patients. For my current survivors, it is of great importance that treatment guidelines are as reliable and effective as possible.

Anonymous Patient Answer

Have there been other clinical trials involving chemotherapy (gemcitabine & docetaxel) plus bio-11006?

The phase II study with bio-11006 is designed to evaluate its activity in patients with advanced/metastatic cancer of the urological tract. Patients included in this trial have previously received chemotherapy and are therefore ineligible for enrollment in this new study. Patients enrolled in this study are those who have received a total of six or more cycles of adjuvant cytotoxic therapy. If they respond to this new treatment option we will move forward with a phase III clinical trial"

Anonymous Patient Answer

What are the common side effects of chemotherapy (gemcitabine & docetaxel) plus bio-11006?

The most common side effect is constipation. Other side effects include vomiting, diarrhea, fever, cough, skin rash, upper respiratory tract infection. Other serious side effects include anemia, neutropenia, hemorrhage, allergic reaction, hypersenosis, allergic reaction. Other side effects are very rare and require further research. It is recommended that patients who are taking Bio-11006 receive a medication/food/treatment/supplements history and be very aware of what is happening to them.

Anonymous Patient Answer

What does chemotherapy (gemcitabine & docetaxel) plus bio-11006 usually treat?

BIO11006 can be used in combination with cytotoxic therapies. The combination of BIO11006 with gemcitabine and docetaxel seemed to significantly improve overall survival; however, it did not influence progression-free survival. Therefore, the combined therapy seems to be an effective method to treat osteosarcoma at least in select patient groups.

Anonymous Patient Answer
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