Actively Recruiting

Phase 1
Age: 12Years - 50Years
All Genders
NCT03093909

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

Led by M.D. Anderson Cancer Center · Updated on 2025-11-10

44

Participants Needed

1

Research Sites

522 weeks

Total Duration

On this page

Sponsors

M

M.D. Anderson Cancer Center

Lead Sponsor

J

James B. and Lois R. Archer Charitable Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 12Years - 50Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with solid tumors that have spread to the lungs and no known curative or survival-prolonging therapy
  • Willingness to follow study treatment and safety monitoring including self-report, pulse oximetry, remote lung tests, and lab tests
  • Adequate organ function: ANC ≥ 1000/mm3, platelet count ≥ 100,000/mm3 without recent transfusion, hemoglobin ≥ 8.0 g/dl, kidney creatinine ≤ 2 times upper limit, liver bilirubin and AST ≤ 5 times upper limit, lung function FVC ≥ 50% predicted, oxygen saturation ≥ 95% at rest without supplemental oxygen
  • Age between 12 and 50 years
  • Performance status: ECOG ≤ 2 if age ≥ 16 years or Lansky play score ≥ 60% if age ≤ 15 years
  • All acute side effects from prior cancer therapy except hair loss resolved to mild or baseline
  • No radiotherapy within 2 weeks before enrollment
  • Previous systemic gemcitabine treatment allowed
Not Eligible

You will not qualify if you...

  • Current treatment with bronchodilators or corticosteroids or active asthma (excluding childhood asthma outgrown)
  • Pregnant or breastfeeding women; females of childbearing potential must have negative pregnancy test and use effective contraception or abstinence during and for one month after treatment; males must use contraception
  • Uncontrolled illnesses including active infection, serious heart conditions, or psychiatric/social issues limiting compliance
  • Baseline symptoms of fever, cough, shortness of breath, wheezing, or fatigue at moderate or worse levels
  • Receiving other cancer treatments like chemotherapy, immunotherapy, or biologics concurrently
  • Unresolved toxicities from prior cancer therapy worse than mild grade, except hair loss and certain lab abnormalities; irreversible toxicities not expected to worsen may be allowed

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

N

Najat C. Daw-Bitar, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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