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

NCT03093909 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2026-05-20

No results posted yet for this study

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.

Conditions

  • Malignant Neoplasm of Bone and Articular Cartilage
  • Malignant Neoplasms of Female Genital Organs
  • Malignant Neoplasms of Independent (Primary) Multiple Sites
  • Malignant Neoplasms of Lip Oral Cavity and Pharynx
  • Malignant Neoplasm of Male Genital Organs
  • Malignant Neoplasms of Mesothelial and Soft Tissue
  • Malignant Neoplasm of Respiratory and Intrathoracic Organ Carcinoma
  • Malignant Neoplasms of Thyroid and Other Endocrine Glands
  • Malignant Neoplasms of Urinary Tract
  • Melanoma and Other Malignant Neoplasms of Skin

Interventions

DRUG

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.

Sponsors & Collaborators

  • James B. and Lois R. Archer Charitable Foundation

    collaborator UNKNOWN

  • Gateway for Cancer Research

    collaborator OTHER

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Najat C. Daw-Bitar, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-22
Primary Completion
2027-11-30
Completion
2027-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03093909 on ClinicalTrials.gov