Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-24 @ 10:52 PM
NCT ID:
NCT01590069
Eligibility Criteria:
Inclusion Criteria:
* Patients with diagnosis of advanced cancer with lung metastases; patients with no prior therapy are eligible if there is no known superior alternative medical therapy; for phase Ib expansion cohort diagnosis of osteosarcoma, lung metastases will be required
* Willing to comply with protocol therapy and required safety monitoring (self-report, pulse oximetry, remote spirometry, labs)
* Creatinine =\< 2 x upper limit of normal (ULN)
* Bilirubin =\< 5 x ULN
* Aspartate aminotransferase (AST) =\< 5 x ULN
* Forced vital capacity (FVC) \>= 50% predicted
* Oxygen (O2) saturation at rest \>= 90% (off supplementary oxygen)
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 for ages \>= 16 or Lansky play \>= 80% for ages =\< 15
* Patients must have recovered to =\< grade 1 toxicity (except alopecia and hearing loss) from any prior chemotherapy, other investigational therapy, hormonal, biological, targeted agents
* No radiotherapy within 2 weeks: exception: patients may receive palliative low dose radiotherapy (30 Gy or less) for lesions outside the lung at the discretion of the treating physician; palliative radiotherapy could be given before aerosol treatment is started if necessary
* Subjects have to be able to read and understand English
* Patients with advanced cancer with resectable lung metastases
* Patients with sarcoma, renal cell carcinoma, or melanoma or with known disease outside the lungs and/or thorax
Exclusion Criteria:
* Currently being treated with bronchodilators or corticosteroids
* Females: pregnant or breast feeding and if of child bearing potential (e.g. female of childbearing age that has not been amenorrheic for at least 12 consecutive month or surgically sterilized) not willing to use effective contraception
* 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 (Common Terminology Criteria for Adverse Events \[CTCAE\] version \[v\] 4.0)
* Patients with unresectable lung metastases
* Patients without sarcoma, renal cell carcinoma, or melanoma
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
50 Years
Study:
NCT01590069
Study Brief:
Protocol Section:
NCT01590069