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Search / Trial NCT03093909

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

Launched by M.D. ANDERSON CANCER CENTER · Mar 23, 2017

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

Solid Tumors And Pulmonary Metastases Aerosol Gemcitabine Aerosol Gcb Lung Metastases Osteosarcoma

ClinConnect Summary

This clinical trial is studying a new way to deliver a medication called gemcitabine, which is usually given through an IV, by having patients inhale it as a mist. The goal is to find the highest dose that patients with certain types of solid tumors, which have spread to the lungs, can safely tolerate. Participants will be closely monitored for any side effects during the study.

To be eligible for this trial, you should be between 12 and 50 years old and have a solid tumor that has spread to the lungs, with no known cure available. You also need to be in good health overall, with specific blood counts and organ function. Participants will not be allowed to take certain medications or have specific health conditions that could interfere with the study. If you join, you can expect regular check-ins and monitoring to ensure your safety throughout the trial at MD Anderson. This research is important as it may help find new treatment options for patients with advanced cancer.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. 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 of life.
  • 2. Willing to comply with protocol therapy and required safety monitoring (self-report, pulse oximetry, remote spirometry, labs).
  • 3. 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 period prior to enrollment), hemoglobin \>/= 8.0g/dl (may receive RBC transfusions), renal-creatinine \</= 2 x ULN; hepatic- bilirubin and AST \</= 5x ULN; pulmonary: FVC \>/=50% predicted, Oxyhemoglobin saturation at rest \>/=95% (off supplemental oxygen).
  • 4. Patient age \>/= 12 years and \</= 50 years.
  • 5. Performance Status: ECOG \</= 2 for patients \>/= 16 years old or Lansky play \>/= 60% for patients \</=15 years old.
  • 6. 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 inclusion criteria.
  • 7. No radiotherapy within 2 weeks.
  • 8. Subjects who received GCB systemically previously are eligible for participation.
  • Exclusion Criteria:
  • 1. 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.
  • 2. 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 of child bearing potential (e.g. female that has not been amenorrheic for at least 12 consecutive months or surgically sterilized). Males or females of reproductive potential will not participate unless they have agreed to use effective contraception for the entire period in which they are receiving protocol therapy and for at least one month after treatment ends. Effective contraception is defined as intrauterine device (IUD), hormonal (birth control pill, injections, implants, patch), tubal ligation and partner's vasectomy. Abstinence is an acceptable method of birth control.
  • 3. 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, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • 4. Subjects with baseline symptoms of fever and/or cough and/or shortness of breath and/or wheezing and/or fatigue grade \>/= 2 (CTCAE v4.0).
  • 5. Patients receiving other concurrent cancer therapy including chemotherapy, immunotherapy, or biologic therapy.
  • 6. 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. Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (eg, hearing loss).

About M.D. Anderson Cancer Center

The University of Texas MD Anderson Cancer Center is a leading institution dedicated to cancer care, research, education, and prevention. As one of the world’s most respected cancer centers, MD Anderson focuses on innovative treatment approaches and groundbreaking clinical trials aimed at improving patient outcomes. With a multidisciplinary team of experts and state-of-the-art facilities, the center is committed to advancing cancer research and providing comprehensive, personalized care to patients. MD Anderson's clinical trials play a pivotal role in translating scientific discoveries into effective therapies, positioning the center at the forefront of cancer treatment and research.

Locations

Houston, Texas, United States

Patients applied

0 patients applied

Trial Officials

Najat C. Daw-Bitar, MD

Principal Investigator

The University of Texas MD Anderson Cancer Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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