Recruiting
Phase 1

Aerosol Gemcitabine

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT03093909

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

Eligibility Criteria

Sex: All

Age: 12 - 50

Healthy Volunteers: Not accepted

Interventions

Gemcitabine

Study Details

Brief 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

Study ID

NCT03093909

Start date

Nov 22, 2017

Status verified date

Jul, 2026

Completion date

Nov 30, 2027

Anticipated

Primary completion date

Nov 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 50

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

44 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Aerosol Gemcitabine (GCB)

Dose Escalation Cohort: Participants take Gemcitabine by mist 2 times each week for 4 weeks (28 days).

Expansion Cohort: Participants with OS lung metastases receive study drug at the maximum tolerated dose from Dose Escalation Cohort.

Participants may continue to receive the study drug for up to 12 cycles per decision of doctor.

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.

Primary outcome measure

  • Maximum Tolerated Dose (MTD) Recommended for Phase 2 Dose of Aerosol Gemcitabine (GCB) [ Time Frame: 4 weeks ]
  • Toxicities of Aerosol Gemcitabine (GCB) [ Time Frame: Reviewed with each 4 week cycle, up to 24 weeks for six dose levels ]

Central Contacts and Locations

Central contacts

Najat C. Daw-Bitar, MD

713-792-3280ndaw@mdanderson.org

Locations

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Jul 15, 2026

Last verified

Jul, 2026

Keywords

  • Solid Tumors and Pulmonary Metastases
  • aerosol gemcitabine
  • aerosol GCB
  • Lung metastases
  • osteosarcoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-07-15.