Study of Aerosol Gemcitabine in Patients With Solid Tumors and Pulmonary Metastases
Phase I Study of Aerosol Gemcitabine in Patients With Solid Tumors and Pulmonary Metastases
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 12 Years to 50 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 4 weeks
- Procedures mentioned: Phone or video check-ins, Physical exams, CT scans, MRI scans, PET scans, X-rays, Blood draws, Pills
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "You will take gemcitabine by mist 2 times each week for 4 weeks (28 days)."
- "Your participation on the study will be over after your last follow-up phone call."
- "Study Visits: Within 3 days before Day 1 of every cycle: * You will have a physical exam. * Blood (about 4 teaspoons) will be drawn for routine tests and to check your liver function. * You will have PFTs. * You will have your blood oxygen level measured by pulse oximeter. * If you can become pregnant, urine will be collected for a pregnancy test."
- "On Day 8 of Cycle 1: * You will have a physical exam. * Blood (about 4 teaspoons) will be drawn for routine tests and to check your liver function."
- "You will have a CT scan at the end of Cycles 2, 4, and 6, and then every 3 cycles after that."
- "If you have a chest X-ray, MRI, and PET scan as part of standard of care while you are on study, the study doctor may use the results to check the status of the disease."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests the highest dose of gemcitabine that people can safely breathe in as a mist. It is for people ages 12 to 50 with solid tumors that have spread to the lungs. Researchers will study side effects; giving this drug as a mist is experimental.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have a solid tumor that has spread to the lungs, with no known treatment that can cure it or help you live longer with an acceptable quality of life.
- Be willing to follow study treatment and safety checks, including blood tests, breathing tests, oxygen checks, and reporting symptoms.
- Meet required blood cell, kidney, and liver test levels. Meet breathing test limits and have oxygen levels of at least 95% at rest without extra oxygen.
- Be 12 to 50 years old.
- Meet the study’s limits for how well you can do daily activities or play.
- Side effects from past cancer treatment must be mild or back to allowed starting levels, except hair loss. Some permanent side effects may be allowed.
- Have had no radiation treatment in the past 2 weeks.
- Past gemcitabine treatment given through the body is allowed.
Who can't join
- Have active asthma or currently take medicines that open the airways or corticosteroids. Childhood asthma that went away does not count.
- Be pregnant or breastfeeding. People who could become pregnant must have a pregnancy test.
- Be able to have children but not agree to use effective birth control during treatment and for at least 1 month afterward. Not having sex is also allowed.
- Have an uncontrolled illness, such as an active infection or certain heart problems, or mental health or social issues that prevent following study rules.
- Have fever, cough, shortness of breath, wheezing, or tiredness rated moderate or worse before treatment.
- Be receiving another cancer treatment, including chemotherapy, immune treatment, or biologic treatment.
- Have more than mild side effects left from past cancer treatment, except hair loss and allowed lab results. Permanent side effects unlikely to worsen, such as hearing loss, may be allowed.
Simplified for readability. The official criteria below are what the study team uses.
Official 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).
Study sites (1)
TX
- The University of Texas MD Anderson Cancer Center · Houston, TX 77030More trials in Houston