Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
unspecified adult solid tumor, protocol specific
Brief summary
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.
Detailed 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.
Interventions
After signing consent, patients will undergo a complete spirometry test, lung volumes and diffusing capacity (DLCO) measurement utilizing the single-breath breath holding technique, according to the ATS/ERS consensus and standardization.
Sponsors
Study design
Eligibility
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DLCO, FVC, and FEV1 as measured by pulmonary function testing | Prior to participation in a Phase I trial |
Countries
United States