Aerosol gemcitabine treatment for patients with solid tumors and lung metastases
Phase I Study of Aerosol Gemcitabine in Patients With Solid Tumors and Pulmonary Metastases
This study is testing a new way to give the cancer drug gemcitabine as a mist to see how much can be safely used for patients with solid tumors that have spread to their lungs.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 12 Years to 50 Years |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT03093909 on ClinicalTrials.gov |
What this trial studies
This clinical research focuses on determining the highest tolerable dose of gemcitabine administered via inhalation to patients with solid tumors that have metastasized to the lungs. Participants will receive the drug as a mist using a nebulizer, with treatment occurring twice a week for four weeks in cycles. The study aims to evaluate the safety and side effects of this investigational method, with up to 44 participants enrolled at MD Anderson Cancer Center. The study will explore multiple dose levels to find the optimal dosage without intolerable side effects.
Who should consider this trial
Good fit: Ideal candidates are patients aged 12 to 50 with solid tumors that have spread to the lungs and for whom no curative therapy exists.
Not a fit: Patients with tumors that are not metastatic to the lungs or those with curable conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new method for delivering gemcitabine directly to lung tumors, potentially improving outcomes for patients with advanced solid tumors.
How similar studies have performed: While gemcitabine is an established treatment for certain cancers, its inhalation method is investigational, making this approach novel.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Houston, Texas
- The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Najat C. Daw-Bitar, MD — M.D. Anderson Cancer Center
- Study coordinator: Najat C. Daw-Bitar, MD
- Email: ndaw@mdanderson.org
- Phone: 713-792-3280
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.