Aerosol Gemcitabine in Treating Participants with Solid Tumors and Lung Metastases

Inclusion Criteria

• 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
• Willing to comply with protocol therapy and required safety monitoring (self-report, pulse oximetry, remote spirometry, labs)
• Peripheral absolute neutrophil count (ANC) >= 750/mm^3 (must be performed within 14 days prior to enrollment)
• Platelet count >= 50,000/mm^3 (transfusion independent defined as not receiving platelet transfusions within a 7 day period prior to enrollment) (must be performed within 14 days prior to enrollment)
• Hemoglobin >= 8.0g/dl (may receive red blood cell [RBC] transfusions) (must be performed within 14 days prior to enrollment) (must be performed within 14 days prior to enrollment)
• Creatinine =< 2 x upper limit of normal (ULN) (must be performed within 14 days prior to enrollment)
• Bilirubin =< 5 x ULN (must be performed within 14 days prior to enrollment)
• Alanine aminotransferase (ALT) =< 5 x ULN (must be performed within 14 days prior to enrollment)
• Forced vital capacity (FVC) >= 50% predicted (must be performed within 14 days prior to enrollment)
• Oxyhemoglobin saturation at rest >= 95% (off supplemental oxygen) (must be performed within 14 days prior to enrollment)
• Patient age >= 10 years and =< 50 years
• Eastern Cooperative Oncology group (ECOG) =< 2 for patients >= 16 years old or Lansky play >= 60% for patients =< 15 years old
• Patients must have resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade =< 1 or to the baseline laboratory values as defined in the inclusion criteria
• No radiotherapy within 2 weeks
• Subjects who received GCB systemically previously are eligible for participation

Exclusion Criteria

• 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
• 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
• 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
• Subjects with baseline symptoms of fever and/or cough and/or shortness of breath and/or wheezing and/or fatigue grade >= 2 (CTCAE version [v]4.0)
• Patients receiving other concurrent cancer therapy including chemotherapy, immunotherapy, or biologic therapy
• 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)