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Study of Aerosol Gemcitabine in Patients With Solid Tumors and Pulmonary Metastases
Sponsor: M.D. Anderson Cancer Center
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.
Official title: Phase I Study of Aerosol Gemcitabine in Patients With Solid Tumors and Pulmonary Metastases
Key Details
Gender
All
Age Range
12 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
44
Start Date
2017-11-22
Completion Date
2027-11-30
Last Updated
2025-11-10
Healthy Volunteers
No
Conditions
Interventions
Gemcitabine
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