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New treatment option for Malignant Neoplasm of Bone and Articular Cartilage
Official title Study of Aerosol Gemcitabine in Patients With Solid Tumors and Pulmonary Metastases
ClinicalTrials.gov ID: NCT03093909
What this study is testing
What is Gemcitabine?
Gemcitabine is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for malignant neoplasm of bone and articular cartilage.
Also referred to as GCB, aerosol gemcitabine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant. The goal of this clinical research study is to find the highest tolerable dose of gemcitabine that can be given by inhalation (breathing it as a mist) to patients with solid tumors that have spread to the lungs from other parts of the body.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 50
You may be able to join if
- Patients with diagnosis of solid tumor with lung metastases and patient's current disease state must be one for which there is no known curative...
- Willing to comply with protocol therapy and required safety monitoring (self-report, pulse oximetry, remote spirometry, labs).
- Adequate organ function as defined by: peripheral absolute neutrophil count (ANC) \>/= 1,000/mm3, platelet count \>/= 100,000/mm3 (transfusion...
- Patient age \>/= 12 years and \</= 50 years.
- Performance Status: ECOG \ /= 16 years old or Lansky play \>/= 60% for patients \</=15 years old.
You likely can't join if
- Currently being treated with bronchodilators or corticosteroids or known to have active asthma. This will not include patients who suffered from...
- Pregnant or breastfeeding women will not be entered into this study due to risks of fetal and teratogenic adverse events as seen in animal studies...
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, bradycardia, related to cardiac disease, bundle branch...
- people with baseline symptoms of fever and/or cough and/or shortness of breath and/or wheezing and/or fatigue grade \>/= 2 (CTCAE v4.0).
- Patients receiving other concurrent cancer therapy including chemotherapy, immunotherapy, or biologic therapy.
- Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE Grade \</= 1 with the exception of alopecia and...
See the full eligibility criteria
- Patients with diagnosis of solid tumor with lung metastases and patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality...
- Willing to comply with protocol therapy and required safety monitoring (self-report, pulse oximetry, remote spirometry, labs).
- Adequate organ function as defined by: peripheral absolute neutrophil count (ANC) \>/= 1,000/mm3, platelet count \>/= 100,000/mm3 (transfusion independent defined as not receiving platelet transfusions within a 7 day...
- Patient age \>/= 12 years and \</= 50 years.
- Performance Status: ECOG \ /= 16 years old or Lansky play \>/= 60% for patients \</=15 years old.
- Patients must have resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to NCI CTCAE Grade \</= 1 or to the baseline laboratory values as defined in the .
- No radiotherapy within 2 weeks.
- people who received GCB systemically previously are eligible for participation.
- Currently being treated with bronchodilators or corticosteroids or known to have active asthma. This will not include patients who suffered from asthma as a child and outgrew it.
- Pregnant or breastfeeding women will not be entered into this study due to risks of fetal and teratogenic adverse events as seen in animal studies. Pregnancy tests must be obtained in females who are post-menarchal and...
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, bradycardia, related to cardiac disease, bundle branch block, symptomatic congestive heart failure, unstable angina pectoris...
- people with baseline symptoms of fever and/or cough and/or shortness of breath and/or wheezing and/or fatigue grade \>/= 2 (CTCAE v4.0).
- Patients receiving other concurrent cancer therapy including chemotherapy, immunotherapy, or biologic therapy.
- Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE Grade \</= 1 with the exception of alopecia and laboratory values listed per the inclusion criteria. people with...
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.