Lung Function Testing in Patients With Locally Advanced or Metastatic Solid Tumors
This trial is active, not recruiting.
|Condition||unspecified adult solid tumor, protocol specific|
|Treatment||pulmonary function testing|
|Sponsor||Barbara Ann Karmanos Cancer Institute|
|Collaborator||National Cancer Institute (NCI)|
|Start date||May 2009|
|End date||April 2017|
|Trial size||48 participants|
|Trial identifier||NCT00914147, CDR0000642265, P30CA022453, WSU-2009-004|
RATIONALE: Measuring how well the lungs work in patients with cancer may help doctors predict how patients will respond to treatment and help plan the best treatment.
PURPOSE: This clinical trial is studying lung function testing in patients with locally advanced or metastatic solid tumors.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
DLCO, FVC, and FEV1 as measured by pulmonary function testing
time frame: Prior to participation in a Phase I trial
Male or female participants from 18 years up to 120 years old.
DISEASE CHARACTERISTICS: - Histologically confirmed solid tumor - Locally advanced or metastatic disease - Disease progressed on or after standard therapy OR there is no standard therapy for the malignancy - Standard therapy is defined as first- or second-line therapy that has been shown to provide clinical benefit - Life-long non-smoker - No lung metastasis and/or pleural effusion causing signs or symptoms that impact patient performance status PATIENT CHARACTERISTICS: - ECOG performance status 0-1 - Body mass index ≤ 35 - No concurrent uncontrolled illness including, but not limited to, the following: - Ongoing or active infection - Symptomatic congestive heart failure - Unstable angina pectoris - Ventricular arrhythmia - Psychiatric illness or social situation that would limit compliance with study requirements - No uncontrolled chest or abdominal pain - No oral or facial pain exacerbated by an oral device - No stress incontinence - No COPD, interstitial lung disease, pulmonary embolism, or hemorrhage within the past 6 months - No history of pulmonary fibrosis or pulmonary hypertension - No oxygen requirement at baseline - No asthma - No occupational lung disease, including, but not limited to, asbestos exposure - No polycythemia - No history of connective tissue disease PRIOR CONCURRENT THERAPY: - No prior radiotherapy to the lung - At least 6 months since prior lung surgery - No prior amiodarone hydrochloride - No prior high-dose chemotherapy with autologous or allogeneic hematopoietic stem cell transplantation - No concurrent combination antiretroviral therapy for HIV-positive patients
|Official title||Pulmonary Function Tests (PFT) in a Phase I Patient Population|
|Principal investigator||Ulka N. Vaishampayan, M.D.|
|Description||OBJECTIVES: Primary - To obtain the distribution of DLCO, FVC, and FEV_1 by pulmonary function testing (PFT) in patients with heavily pretreated locally advanced or metastatic solid tumors referred to the Karmanos Cancer Institute (KCI) Phase I Clinical Trials Program. - To estimate the mean DLCO to within 4 units (% of predicted) of the true mean with 95% confidence. Secondary - To estimate the percentage of patients who meet the defined eligibility criteria (including PFT levels, especially DLCO) from the entire population enrolled in the KCI Phase I Clinical Trials Program. OUTLINE: Patients undergo pulmonary function testing comprising spirometry test, lung volumes, and DLCO measurement utilizing the single-breath breath-holding technique. Patients then proceed to treatment on a phase I clinical trial.|
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