RecruitingPhase 1NCT03093909

Study of Aerosol Gemcitabine in Patients With Solid Tumors and Pulmonary Metastases

Phase I Study of Aerosol Gemcitabine in Patients With Solid Tumors and Pulmonary Metastases


Sponsor

M.D. Anderson Cancer Center

Enrollment

44 participants

Start Date

Nov 22, 2017

Study Type

INTERVENTIONAL

Conditions

Summary

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. The safety and side effects of this drug will also be studied. This is an investigational study. Gemcitabine is FDA approved and commercially available for the treatment of pancreatic and lung cancer, and other solid tumors. Its administration by inhalation is investigational. The study doctor can explain how the study drug is designed to work. Up to 44 participants will be enrolled in this study. All will take part at MD Anderson.


Eligibility

Min Age: 12 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether a chemotherapy drug called gemcitabine, delivered as an inhaled mist (aerosol) directly into the lungs, is safe and effective for patients whose cancer has spread to the lungs. **You may be eligible if...** - You have a solid tumor (any type) that has spread to your lungs - There is no standard treatment known to cure or significantly extend your life - You are between 12 and 50 years old - Your blood counts, kidney, liver, and lung function are within acceptable ranges - Your lungs can hold at least 50% of their expected air capacity and your oxygen levels are normal without supplemental oxygen - You are able to carry out basic daily activities with only mild limitations - Any side effects from previous cancer treatments have mostly resolved - You have not received radiation therapy in the last 2 weeks **You may NOT be eligible if...** - You currently use bronchodilators (inhalers) or steroids for a breathing condition, or have active asthma - You are pregnant or breastfeeding - You have an active, uncontrolled infection - You have received certain other experimental treatments recently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGGemcitabine

Nebulized dose of aerosol GCB twice a week continuously (escalating treatment dose schema, starting at 0.75 mg/kg to 3.0 mg/kg). Participants receive a pre-determined volume of nebulized solution, according to the dose level and weight of the participant, with each aerosol GCB administration. One cycle is 4 weeks in duration.


Locations(1)

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT03093909


Related Trials