Forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) > 60% by pulmonary function test (PFT), unless due to large mediastinal mass from Hodgkin lymphoma (HL)
Diffusion capacity of the lung for carbon monoxide (DLCO) >= 40% of predicted (corrected or uncorrected for hemoglobin per institutional standards)
Forced expiratory volume in 1 second (FEV1) >= 40% of predicted (corrected or uncorrected for hemoglobin per institutional standards)
Forced vital capacity (FVC) >= 40% of predicted (corrected or uncorrected for hemoglobin per institutional standards)
Patients must have postoperative predicted forced expiratory volume (FEV) > 35% prior to surgery obtained within 28 days prior to step 2 registration
Patients must have postoperative predicted carbon monoxide diffusing capability (DLCO) > 35% prior to surgery obtained within 28 days prior to step 2 registration
Patients must have pulmonary function sufficient to receive bleomycin, with normal lung expansion, absence of crackles on auscultation, and normal carbon monoxide diffusion (DLCO), defined as greater than 80% predicted
DLCO/VA and FEV1 ? 50% of predicted on PFTs.
Patients must have a forced expiratory volume in one second (FEV-1) and diffusing capacity of the lung for carbon monoxide (DLCO) > 50% predicted
Corrected diffusion capacity of carbon monoxide (DLCO) < 40%, total lung capacity (TLC) < 40%, forced expiratory volume in one second (FEV1) < 40% and/or receiving supplementary continuous oxygen
Forced expiratory volume in one second (FEV1) and carbon monoxide diffusion capacity (DLCO) (adjusted for hemoglobin [Hb]) >= 50% adjusted
Forced expiratory volume in 1 second (FEV-1) or diffusion capacity of the lung for carbon monoxide (DLCO) (corrected for hemoglobin) >= 50% predicted; timeline: within 4 weeks prior to enrollment
Pulmonary function forced expiratory volume in 1 second (FEV1) >= 50% of predicted
Forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) >= 40% of predicted; or in pediatric patients, if unable to perform pulmonary function tests due to young age, oxygen saturation > 92% on room air
Pulmonary function tests within 6 months of study enrollment must have forced expiratory volume in 1 second (FEV1) >= 1.2 L and diffusing capacity of the lung for carbon monoxide (DLCO) >= 40% of predicted; patients with FEV1 of < 1.2 L but a predicted value of >= 40% may be eligible after review of the case by the study radiation primary investigator (PI) or his designee
Pulmonary function (FVC, FEV1 and corrected DLCO) > 50% predicted.
Chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (FEV1) is less than (<) 50 % of predicted normal
Subject has known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) < 50% of predicted normal\r\n* Note that FEV1 testing is required for patients suspected of having COPD and subjects must be excluded if FEV1 < 50% of predicted normal
Participants with unilateral pleural effusion are eligible if they fulfill both of the following: (a) New York Heart Association (NYHA) Class 1; (b) Global initiative for obstructive lung disease (GOLD) test level 1 (forced expiratory volume in 1 second [FEV1]/ forced vital capacity [FVC] less than [<] 0.7 and FEV1 greater than or equal to [>=] 80 percent [%] predicted after inhaled bronchodilator)
Patients with Adequate Physical Function as Measured by: a. Cardiac: Left ventricular ejection fraction at rest must be greater than or equal to 40%, or shortening fraction less than 25%; b. Hepatic: Bilirubin less than or equal to 2.5 mg/dL, except for patients with Gilbert's syndrome or hemolysis. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and Alkaline Phosphatase less than 5 x upper limit of normal; c. Renal: Serum creatinine within normal range, or if serum creatinine outside normal range, then renal function (measured or estimated creatinine clearance or GFR)greater than 40 mL/min/1.73m^; d. Pulmonary: Diffusing capacity of the lung for carbon monoxide (DLCO) (corrected for hemoglobin), forced expiratory volume in one second (FEV1), and forced vital capacity (FVC) greater than 50% predicted;
Pulmonary function: Diffusing capacity of the lung for carbon monoxide (DLCO) ? 40% (adjusted for hemoglobin) and forced expiratory volume in one second (FEV1) ? 50%
Participant has diffusing capacity of the lung for carbon monoxide (DLCO) (corrected for hemoglobin) ? 50% predicted and/or forced expiratory volume in 1 second (FEV1) ? 50% predicted.
Pulmonary: For patients > 13.0 years of age: Diffusing capacity of the lung for carbon monoxide (DLCO) (corrected/adjusted for hemoglobin) > 40% and forced expiratory volume in one second (FEV1) > 50% predicted (without administration of bronchodilator) and forced vital capacity (FVC) > 50% predicted. For patients < 13.0 years of age unable to perform pulmonary function tests (PFT) due to age or developmental ability: (1) no evidence of dyspnea at rest and (2) no need for supplemental oxygen and (3) O2 saturation > 92% on room air at sea level (with lower levels allowed at higher elevations per established center standard of care (e.g., Utah, 4,200 feet above sea level, does not give supplemental oxygen unless below 90%)).
TREATMENT INCLUSION: Adequate pulmonary function with forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and diffusion capacity of the lung for carbon monoxide (DLCO) ? 50% of expected corrected for hemoglobin
PFTs including forced expiratory volume in 1 second (FEV1) within 26 weeks prior to registration; for FEV1, the best value obtained pre- or post-bronchodilator must be >= 0.8 liters/second or >= 50% predicted
All patients must have an forced expiratory volume in 1 second (FEV1) >= 700cc
All patients must have a carbon monoxide diffusing capability test (DLCO) >= 5.5 m/min/mmHg
Pulmonary function tests: diffusing capacity of the lungs for carbon monoxide (DLco) (corrected for hemoglobin) and forced expiratory volume in 1 second (FEV1) >= 50% of predicted for the MAC arm, >= 40% of predicted for the RIC and RIC-MMF arm, and >= 30% predicted for the IOC arm; or in pediatric patients, if unable to perform pulmonary function tests, there should be no evidence of dyspnea at rest, no requirement for supplemental oxygen, and oxygen saturation > 92% on room air; calculations will be based on the Unites States of America National Institutes of Health (USA-ITS-NIH) reference
Diffusing capacity of the lungs for carbon monoxide (DLCO) >= 50%
Forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) >= 50% predicted
Pulmonary: FEV 1, FVC, DLCO (diffusion capacity) ? 50% predicted (corrected for hemoglobin)
Documented diffusion capacity of the lung for carbon monoxide (DLCO) < 50% (if performed within 90 days of enrollment) or requirement for supplemental oxygen
Diffusing capacity of the lung for carbon monoxide (DLCO) corrected < 60%; patients who are unable to perform pulmonary function tests (for example, due to young age and/or developmental status) will be excluded if the oxygen (O2) saturation is < 92% on room air
Documented forced expiratory volume in 1 second (FEV1) of less than or equal to 50% predicted in patients with clinical symptomatology
Document forced expiratory volume in 1 second (FEV1) less than or equal to 60% predicted tested in patients with:\r\n* A prolonged history of cigarette smoking (20 pack [pk]/year of smoking within the past 2 years).\r\n* Symptoms of respiratory dysfunction
Forced expiratory volume in one second (FEV1) or diffusing capacity of the lung for carbon monoxide (DLCO) < 40% or need for use of supplemental oxygen
Documented forced expiratory volume in 1 second (FEV1) less than or equal to 60% predicted tested in patients with:\r\n* A prolonged history of cigarette smoking (20 packs [pk]/year of smoking within the past 2 years)\r\n* Symptoms of respiratory dysfunction
Documented forced expiratory volume in 1 second (FEV1) less than or equal to 60% predicted tested in patients with:\r\n* A prolonged history of cigarette smoking (20 pack [pk]/year of smoking within the past 2 years)\r\n* Symptoms of respiratory dysfunction
Patients with impaired pulmonary function as evidenced by diffusion capacity of the lung for carbon monoxide (DLCO) < 50% of predicted (or, if unable to perform pulmonary function tests, then oxygen [O2] saturation < 92% on room air)
Diffusion capacity for carbon monoxide corrected (DLCOcorr) > 50% normal or a pediatric patient who is unable to perform pulmonary function tests (PFTs) but has adequate pulmonary function
Documented forced expiratory volume in one second (FEV1) =< 50% predicted tested in patients with:\r\n* A prolonged history of cigarette smoking (approximately 20 packs/year within the past 2 years).\r\n* Symptoms of respiratory dysfunction
Pulmonary: Asymptomatic or if symptomatic, diffusion capacity of the lung for carbon monoxide (DLCO) > 50% of predicted (corrected for hemoglobin).
Forced expiratory volume in one second (FEV1) of < 50% predicted or carbon monoxide diffusing capacity (DLCO) (corrected) < 40% (patients with clinically significant pulmonary dysfunction, as determined by medical history and physical exam should undergo pulmonary function testing)
Carbon monoxide diffusing capacity (DLCO) and forced expiratory volume in 1 second (FEV1) > 50% predicted
Carbon monoxide diffusing capacity (DLCO) 40% predicted.
Known severe chronic obstructive pulmonary disease or asthma defined as forced expiratory volume (FEV1) in 1 second less than < 60% of expected
Pulmonary function tests including diffusing capacity of the lung for carbon monoxide (DLCO) will be performed; forced expiratory volume in 1 second (FEV 1) and DLCO should be greater than 50% of predicted normal value
Pulmonary function tests (spirometry) demonstrating forced expiratory value (FEV) 1 greater than 65% predicted or forced vital capacity (FVC) greater than 65% of predicted.
Pulmonary function (spirometry and corrected diffusion capacity of the lung for carbon monoxide [DLCO]) >= 50% predicted.
Corrected diffusion capacity of the lung for carbon monoxide (DLCOc) >= 50%;
Patients who have obstructive or restrictive pulmonary disease and have a documented FEV1 (forced expiratory volume in 1 second) of ? 60%
Documented forced expiratory volume-one second (FEV1) less than or equal to 50% predicted tested in patients with:\r\n* A prolonged history of cigarette smoking (approximately 20 packs/year within the past two years)\r\n* Symptoms of respiratory dysfunction
Diffusion capacity of the lung for carbon monoxide/alveolar volume ratio (DLCO/VA) and forced expiratory volume in 1 second (FEV1) >= 50% of predicted on pulmonary function tests (subjects must have pulmonary function tests performed to be eligible)
Participant must be considered ineligible for induction therapy defined by the following: a. >= 75 years of age; or b. >= 18 to 74 years of age with at least one of the following comorbidities: i. Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or 3; ii. Cardiac history of Congestive Heart Failure (CHF) requiring treatment or Ejection Fraction <= 50% or chronic stable angina; iii. Diffusing capacity of the Lung for Carbon Monoxide (DLCO) <= 65% or Forced Expiratory Volume in 1 second (FEV1) <= 65%; iv. Creatinine clearance >= 30 mL/min to < 45 ml/min; v. Moderate hepatic impairment with total bilirubin > 1.5 to <= 3.0 × Upper Limit of Normal (ULN); vi. Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy must be reviewed and approved by the AbbVie Therapeutic Medical Director during screening and before study enrollment.
Hemoglobin-adjusted diffusing capacity of carbon monoxide (DLCO) of >= 45%
Pulmonary function: Carbon monoxide diffusing capability (DLCOc) < 40% normal
Major organ dysfunction defined as:\r\n* Creatinine clearance < 20 ml/min\r\n* Significant hepatic dysfunction (serum glutamic-oxaloacetic transaminase [SGOT] > 5 x upper limit of normal; bilirubin > 3.0 mg/dL)\r\n* Forced expiratory volume in 1 second (FEV1) of < 50% predicted or diffusion capacity of the lung for carbon monoxide (DLCO) (corrected) < 40% (patients with clinically significant pulmonary dysfunction, as determined by medical history and physical exam should undergo pulmonary function testing)
Diffusing capacity of the lung for carbon monoxide (DLCO) > 40% predicted, corrected for hemoglobin and/or alveolar ventilation
Adjusted (Adj) carbon monoxide diffusing capability (DLCO) > 45% of predicted corrected for hemoglobin
Subjects must have had recent pulmonary function test (PFT) measured for at least 3 months prior to study enrollment that show:\r\n* A decrease in % forced vital capacity (FVC) and/or % forced expiratory volume in 1 second (FEV1) ? 20% at screening compared with pre-transplant baseline\r\n* Lack of bronchodilator response on PFT testing < 12% change and < 200 ml change in FEV1 and/or FVC
Diffusion capacity > 45% (adjusted for hemoglobin) as predicted by pulmonary function testing
Within 4 weeks before enrollment: Diffusion capacity > 45% (adjusted for hemoglobin) as predicted pulmonary function testing
Pulse oximetry with a baseline O2 saturation of >= 90% and diffusion capacity of the lung for carbon monoxide (DLCO) > 40% (corrected for hemoglobin)
Severe obstructive airway disease defined by forced expiratory volume at one second (FEV1) < 50%
Adequate pulmonary function, defined as ? grade 1 dyspnea and saturated oxygen (SaO2) >= 92% on room air; if pulmonary function test (PFT)s are performed based on the clinical judgment of the treating physician, patients with forced expiratory volume in 1 second (FEV1) >= 50% of predicted and carbon monoxide diffusing capability (DLCO) (corrected) of >= 40% of predicted will be eligible
Adequate pulmonary function, defined as ? grade 1 dyspnea and SaO2 ? 92% on room air; if PFTs are performed based on the clinical judgment of the treating physician, patients with FEV1 ? 50% of predicted and DLCO (corrected) of ? 40% of predicted will be eligible
Patients must be without evidence of unstable or decompensated myocardial disease; and must have adequate pulmonary reserve evidenced by forced expiratory volume in 1 second (FEV1) and diffusion capacity of the lung for carbon monoxide (DLCO) >= 35% predicted; carbon dioxide partial pressure (pCO2) < 50 mm Hg and partial pressure of oxygen (pO2) > 60 mm Hg on room air arterial-blood gas (ABG)
Known forced expiratory volume in 1 second (FEV1) or corrected carbon monoxide diffusing capability (cDLCO) < 50% of predicted
Pulmonary function tests within past 6 months showing diffusion capacity of the lung for carbon monoxide (DLCO) > 50% of predicted
Oxygen saturation >= 90% on room air; pulmonary function test (PFT)’s required only if symptomatic or prior known impairment - must have pulmonary function > 50% corrected carbon monoxide diffusing capability (DLCO) and forced expiratory volume in 1 second (FEV1) (within 28 days of study registration)
If pulmonary function tests (PFTs) are performed, the forced expiratory volume 1 (FEV1)/forced vital capacity (FVC) must be greater than 60%
Documented forced expiratory volume in 1 second (FEV1) less than or equal to 50% predicted tested in patients with:\r\n* A prolonged history of cigarette smoking (20 packs [pk]/year of smoking within the past 2 years)\r\n* Symptoms of respiratory dysfunction
Diffusion capacity of the lung for carbon monoxide (DLCO), forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) > 50% predicted
Patients with moderate to severe lung disease including: \r\n* Patients requiring oxygen (O2) supplementation\r\n* Patients unable to walk 50 feet without stopping to rest\r\n** Obstructive lung disease as defined by pre-transplant forced expiratory volume in one second (FEV1) =< 60% of predicted\r\n** Restrictive lung disease as defined by pre-transplant forced vital capacity (FVC) < 60% of predicted
Forced expiratory volume in 1 second (FEV1) > 1.0 L
Corrected diffusing capacity of the lungs for carbon monoxide (DLCO) < 35% or receiving supplemental continuous oxygen
No significant obstructive airways disease (forced expiratory volume in 1 second [FEV1] must be >= 50%) and must have acceptable diffusion capacity (corrected carbon monoxide diffusing capability [DLCO] > 50% of predicted)
Corrected carbon monoxide diffusing capability (DLCOc) >= 50%
Patients with medically inoperable stage I disease (T1 or T2a [tumor size =< 5 cm] N0M0) or selected stage IIa disease (T2 [tumor size > 5 cm but =< 7 cm] N0M0) who have poor lung function or other significant cardiovascular or other comorbidity such as diabetes are eligible. Patients with operable disease who choose to have SABR are also eligible. The standard justification for medical inoperability is based on pulmonary function and can include any of the following: baseline forced expiratory volume in 1 second (FEV1) < 50% of predicted value; diffusion capacity < 50% of predicted value; baseline hypoxemia or hypercapnia; exercise oxygen consumption < 50% of predicted value; severe pulmonary hypertension; severe cerebral, cardiac, or peripheral vascular disease; and severe chronic heart disease
Pulmonary function test (PFT) demonstrating a diffusion capacity of least 50% predicted.
Forced vital capacity (FVC) >= 50% predicted
Clinically significant pulmonary dysfunction, as determined by medical history and physical examination; patients with a history of pulmonary dysfunction must have pulmonary function tests with a forced expiratory volume in 1 second (FEV1) >= 60% of predicted and a diffusing capacity of the lung for carbon monoxide (DLCO) >= 55% (corrected for hemoglobin)
Oxygen saturation >= 90% on room air; pulmonary function tests (PFT’s) required only if symptomatic or prior known impairment - must have pulmonary function > 50% corrected diffusion capacity of the lung for carbon monoxide (DLCO) and forced expiratory volume in 1 second (FEV1)
? 18 to 74 years of age and fulfill at least one criteria associated with lack of fitness for intensive induction chemotherapy: i. Eastern Cooperative Oncology Group (ECOG) Performance status of 2 - 3; ii. Cardiac history of Congestive Heart Failure (CHF) requiring treatment or Ejection Fraction ? 50% or chronic stable angina; iii. Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) ? 65% or Forced Expiratory Volume in 1 second(FEV1) ? 65%; iv. Creatinine clearance ? 30 mL/min to < 45 ml/min; v. Moderate hepatic impairment with total bilirubin > 1.5 to ? 3.0 × Upper Limit of Normal (ULN); vi. Other comorbidity that the physician judges to be incompatible with conventional intensive chemotherapy which must be reviewed and approved by the study medical monitor before study enrollment.
Subject has known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) < 50% of predicted normal. NOTE: FEV1 testing is required for patients suspected of having COPD and subjects must be excluded if FEV1 < 50% of predicted normal
Oxygen saturation >= 90% on room air; pulmonary function tests (PFT’s) required only if symptomatic or prior known impairment - must have pulmonary function > 50% corrected diffusion capacity of the lung for carbon monoxide (DLCO) and forced expiratory volume in 1 second (FEV1)
Carbon monoxide diffusing capability test (DLCO) (adjusted for hemoglobin) >= 50% of predicted and forced expiratory volume in 1 second (FEV-1) >= 50%
Oxygen saturation >= 90% on room air; if symptomatic or prior known impairment, pulmonary function >= 50% corrected diffusing capacity of the lungs for carbon monoxide (DLCO) and forced expiratory volume (FEV)1 is required, within 14 days of study registration (within 30 days for pulmonary and cardiac assessments)
Known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) <50% of predicted normal. Note that FEV1 testing is required for subjects suspected of having COPD and subjects must be excluded if FEV1 is <50% of predicted normal.
Adequate pulmonary function with forced expiratory volume in one second (FEV1), forced vital capacity (FVC) and diffusion lung capacity (DLCO) (corrected for hemoglobin [Hgb]) >= 50% of the predicted value
Patients with pulmonary function test abnormalities as evidenced by a forced expiratory volume in 1 second to forced vital capacity ratio measurement (FEV1/FVC) < 70% of predicted for normality will be excluded
Diffusion capacity of the lung for carbon monoxide (DLCO) > 60%
Diffusion capacity of the lung for carbon monoxide (DLCO) < 40% of normal or oxygen saturation (O2 Sat) < 92%
Carbon monoxide diffusing capability (DLCO) (corrected for hemoglobin), forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) > 50% predicted
Diffusing capacity of the lungs for carbon monoxide (DLCO), forced expiratory volume 1 (FEV1), forced vital capacity (FVC) > 40% predicted, and absence of oxygen (O2) requirements; for children that are not able to cooperate with pulmonary function tests (PFTs), a pulse oximetry with exercise should be attempted; if nether test can be obtained it should be clearly stated in the provider’s note
Diffusing capacity for carbon monoxide (DLCO) >= 45% predicted corrected for hemoglobin
Forced expiratory volume in 1 second (FEV1) >= 30% of predicted postoperative (ppoFEV1, as if patient underwent a pneumonectomy)
Diffusing capacity of the lungs for carbon monoxide (DLCO) > 35% predicted
Pulmonary function test including diffusion capacity of the lung for carbon monoxide (DLCO) will be performed; forced expiratory volume in 1 second (FEV1) and DLCO should be greater than 50% of predicted normal value
Carbon monoxide diffusing capability (DLCO) >= 40% predicted
Diffusing capacity >= 45% (adjusted for hemoglobin) predicted by pulmonary function testing
Hemoglobin adjusted pulmonary carbon monoxide diffusing capability test (DLCO) >= 50% of predicted
Adequate pulmonary function with forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and diffusion capacity of the lung for carbon monoxide (DLCO) >= 50% of expected corrected for hemoglobin and/or volume; children unable to perform pulmonary function tests (e.g., less than 7 years old) pulse oximetry of >= 92% on room air
For patients >= 8 years of age (or otherwise able to complete pulmonary function testing per established American Thoracic Society standards), diffusing capacity of the lungs for carbon monoxide (DLCO) (corrected/adjusted for hemoglobin) > 40% and forced expiratory volume in one second (FEV1) > 50% predicted (without administration of bronchodilator) and forced volume vital capacity (FVC) > 50% predicted
Documented forced expiratory volume in 1 second (FEV1) =< 60% predicted tested in patients with:\r\n* A prolonged history of cigarette smoking (approximately 20 packs/year within the past 2 years)\r\n* Symptoms of respiratory dysfunction
Forced expiratory volume in 1 second (FEV1) and carbon monoxide diffusing capability test (DLCO) >= 40% predicted (or per institutional standard)
Diffusing capacity of the lungs for carbon monoxide (DLCO) >= 50% of predicted after correction for anemia
Adjusted diffusion capacity of the lung for carbon monoxide (DLCO), forced expiratory volume in 1 second (FEV1), and forced vital capacity (FVC) >= 50% of predicted value (corrected for hemoglobin)
Low likelihood of being eligible for reduced intensity conditioning HCT based on known information\r\n* Cardiac ejection fraction < 40% or symptomatic coronary artery disease or uncontrolled arrhythmia\r\n* Diffusing capacity of the lungs for carbon monoxide (DLCOc) < 40% or forced expiratory volume in 1 second (FEV1) < 50%\r\n* Estimated glomerular filtration rate (GFR) < 40 ml/min\r\n* Need for supplemental oxygen\r\n* Direct bilirubin or alanine aminotransferase (ALT) > 2 x upper limit of normal, unless these abnormalities are thought to be related to Gilbert’s disease or leukemic infiltration of hepatic parenchyma
Pre-treatment pulmonary function tests (PFTs), collected =< 90 days prior to enrollment, must show forced expiratory volume in one second (FEV1) > 60% of predicted
Diffusing capacity of the lungs for carbon monoxide (DLCO), forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) >= 40% predicted, and absence of oxygen (O2) requirements; for children that are not able to cooperate with pulmonary function tests (PFTs), a pulse oximetry with exercise should be attempted; if neither test can be obtained it should be clearly stated in the physician’s note
Have adequate pulmonary function to tolerate surgery; patients must have a diffusing lung capacity for carbon monoxide (DLCO) > 35% of predicted post operative forced expiratory volume in 1 second (FEV1) (ppoFEV1) > 35% of predicted
Adequate pulmonary function, defined as Common Terminology Criteria for Adverse Events (CTCAE) grade =< 1 dyspnea and oxygen saturation (SaO2) >= 92% on room air; patients with clinically significant pulmonary dysfunction, as determined by medical history and physical exam should undergo pulmonary function testing and must have a forced expiratory volume in 1 second (FEV1) >= 50% of predicted value or diffusing capacity of the lung for carbon monoxide (DLCO; corrected) >= 40% of predicted value
Patients with clinically significant pulmonary dysfunction, as determined by medical history and physical exam should undergo pulmonary function testing; those with a forced expiratory volume in 1 second (FEV1) of =< 65% or diffusion capacity of the lung for carbon monoxide (DLCO) (corrected) < 40% will be excluded
Diffusing capacity divided by the alveolar volume (DDLCO/VA) and forced expiratory volume (FEV) – 1.0 > 50% of predicted on pulmonary function tests
Patients must have BOS as defined by the NIH consensus criteria (2014 updated criteria); to meet the criteria for BOS, all of the following must be present, in addition to at least one distinctive manifestation of cGVHD:\r\n* FEV1/vital capacity < 0.7 or the fifth percentile of predicted\r\n* FEV1 < 75% of predicted with >= 10% decline over less than 2 years; FEV1 should not correct to > 75% with albuterol, and the absolute decline for the corrected values should still remain at >= 10% from pre-transplant\r\n* Absence of infection in the respiratory tract\r\n* One of the 2 supporting features of BOS:\r\n** Evidence of air trapping by expiratory computed tomography (CT) or small airway thickening or bronchiectasis by high-resolution CT, or\r\n** Evidence of air trapping by PFTs: residual volume > 120% predicted or residual volume/total lung capacity elevated outside the 90% confidence interval\r\n* If a patient carries the diagnosis of cGVHD by virtue of organ involvement elsewhere, then only the first 3 criteria above are necessary
Corrected diffusing capacity for carbon monoxide (DLCOcorr) >= 40% predicted, and absence of oxygen (O2) requirements; for children that are not able to cooperate with pulmonary function tests (PFTs), a pulse oximetry with or without exercise should be attempted; if neither test can be obtained it should be clearly stated in the physician’s note
Diffusing capacity of the lungs for carbon monoxide (DLCO) (corrected for hemoglobin) > 40%
Forced expiratory volume in 1 second (FEV1) > 50%
Patients who have a significant history of pulmonary disease that necessitates the use of supplemental oxygen, is associated with dyspnea on walking one block or less, or requires inhaler therapy more than once per week will be required to undergo pulmonary function testing within 6 months of screening and will be excluded if forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), or diffusing capacity of the lungs for carbon monoxide (DLCO) is less than 65% of predicted
Adequate pulmonary function defined as NO severe or symptomatic restrictive or obstructive lung disease, and formal pulmonary function testing showing an forced expiratory volume in 1 second (FEV1) >= 50% of predicted and a diffusion capacity of the lungs for carbon monoxide (DLCO) >= 40% of predicted, corrected for hemoglobin
Documented forced expiratory volume in 1 second (FEV1) less than or equal to 60% predicted tested in patients with:\r\n* A prolonged history of cigarette smoking (20 packs (pk)/year of smoking within the past 2 years)\r\n* Symptoms of respiratory dysfunction
Forced expiratory volume in 1 second (FEV1) >= 50%
Forced vital capacity (FVC) >= 50%
Diffusion capacity of the lungs for carbon monoxide (DLCO) (corrected for hemoglobin [Hgb]) >= 50%
Clinically significant pulmonary dysfunction, as determined by medical history and physical exam; patients so identified will undergo pulmonary functions testing and those with forced expiratory volume in 1 second (FEV1) < 2.0 L or diffusion capacity of the lung for carbon monoxide (DLco) (corrected [corr] for hemoglobin [Hgb]) < 50% will be excluded
DLCO (diffusing capacity of the lung for carbon monoxide) >= 45% of predicted corrected for hemoglobin, FEV-1 (forced expiratory volume at 1 second) >= 50% of predicted
Forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and corrected diffusing capacity of the lungs for carbon monoxide (DLCO) >= 40%
Adequate pulmonary function as defined by forced vital capacity (FVC) and diffusing capacity of the lung for carbon monoxide (DLCO) >= 50% of predicted by pulmonary function testing
If measured, carbon monoxide diffusion capacity (DLCO) > 50%
Adequate pulmonary function with forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and diffusion capacity of the lung for carbon monoxide (DLCO) >= 50% of expected corrected for hemoglobin and/or volume
Pulmonary function tests (forced expiratory volume in 1 second [FEV1] > 65% or forced vital capacity [FVC] > 65% of predicted) within 1 month of lymphodepletion
Other serious medical conditions considered to represent contraindications to bone marrow transplant (BMT) (e.g., abnormally decreased cardiac ejection fraction, diffusion capacity of the lung for carbon monoxide [DLCO] < 50% predicted, patient on supplemental oxygen, acquired immune deficiency syndrome [AIDS], etc.)
Diffusing capacity of the lung for carbon monoxide (DLCO) and forced expiratory volume in one second (FEV1) > 60% predicted
Diffusing capacity of the lung for carbon monoxide (DLCO) >= 50% predicted after correction for hemoglobin (must be performed in patients with history of smoking or lung disease); DLCO may be omitted in patients without history of pulmonary disease if approved by the study chair
Diffusing capacity of the lung for carbon monoxide (DLCO) < 40% predicted
Corrected diffusion capacity of the lung for carbon monoxide (DLCOcorr) > 50% if symptomatic or prior known impairment
Diffusing capacity of the lung for carbon monoxide (DLCO) > 50% of the expected value (using USA-ITS-NIH [United States of America National Institutes of Health] equation) when corrected for hemoglobin (Hgb) (DLCO adjustment [Adj.])
Forced expiratory volume in one second (FEV1) > 65% of predicted measured, or diffusing capacity of the lung for carbon monoxide (DLCO) > 50% of predicted measured
Diffusing lung capacity for carbon monoxide (DLCO), forced expiratory volume in one second (FEV1), forced vital capacity (FVC) > 50%; DLCO should be corrected for hemoglobin
Within 90 days of registration: pulmonary function tests (PFTs) including forced expiratory volume in one second (FEV-1) and diffusing capacity of the lung for carbon monoxide (DLCO)
Subjects must have adequate lung function to permit surgical resection determined by pre-enrollment pulmonary function tests to include diffusing capacity of the lungs for carbon monoxide (DLCO)
PART 2: Diffusing capacity of the lung for carbon monoxide (DLCO) corrected > 60% normal\r\n* May not be on supplemental oxygen
Forced expiratory volume in 1 second (FEV1) >= 50% of expected corrected for hemoglobin and/or volume
Forced vital capacity (FVC) >= 50% of expected corrected for hemoglobin and/or volume
Diffusing capacity of the lungs for carbon monoxide (DLCO) >= 50% of expected corrected for hemoglobin and/or volume
Carbon monoxide diffusing capability test (DLCO) or forced expiratory volume in 1 second (FEV1) < 65% predicted
Forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1) and diffusion capacity of the lung for carbon monoxide (DLCO) (corrected) should be 50% or above of expected
Corrected diffusing capacity of the lung for carbon monoxide (DLCOcorr) < 40% normal
Forced expiratory volume in 1 second (FEV1) >= 40% predicted (corrected for hemoglobin); if unable to perform pulmonary function tests, the oxygen (O2) saturation > 92% on room air
Forced vital capacity (FVC) >= 40% predicted (corrected for hemoglobin); if unable to perform pulmonary function tests, the O2 saturation > 92% on room air
Diffusion capacity of the lung for carbon monoxide (DLCO) >= 40% predicted (corrected for hemoglobin); if unable to perform pulmonary function tests, the O2 saturation > 92% on room air
Diffusion capacity of carbon monoxide (DLCO) or forced expiratory volume in one second (FEV1) > 45% predicted
Documented forced expiratory volume in 1 second (FEV1) less than or equal to 60% predicted tested in patients with:\r\n* A prolonged history of cigarette smoking (20 pack [pk]/year of smoking within the past 2 years)\r\n* Symptoms of respiratory dysfunction
Diffusing capacity of the lung for carbon monoxide (DLCO) or forced expiratory volume in 1 second (FEV1) > 45% predicted
Pulmonary function tests (forced expiratory volume in 1 second [FEV1], forced vital capacity [FVC], carbon monoxide diffusing capability [DLCO] >= 40%
Diffusion capacity of the lung for carbon monoxide (DLCO) < 40%
Forced expiratory volume in one second (FEV1) < 50% (corrected for hemoglobin)
Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g., active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol\r\n* Significant symptomatic deterioration of lung function; if clinically indicated, pulmonary function tests including measures of predicted lung volumes, diffusing capacity of the lung for carbon monoxide (DLco), oxygen (O2) saturation at rest on room air should be considered to exclude pneumonitis or pulmonary infiltrates
Documented forced expiratory volume in 1 second (FEV1) less than or equal to 60% predicted tested in patients with:\r\n* A prolonged history of cigarette smoking (20 pack [pk]/year of smoking within the past 2 years)\r\n* Symptoms of respiratory dysfunction
Pulmonary function tests: Forced expiratory volume in one second (FEV1) and carbon monoxide diffusion capacity (DLCO) (adjusted for Hb) >= 50% adjusted of predicted normal value
Pulmonary function with forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and diffusing capacity of the lungs for carbon monoxide (DLCO) at least 45% of expected corrected for hemoglobin; children unable to perform pulmonary functions must have an oxygen saturation greater than 92% at room air
Corrected diffusing capacity of the lung for carbon monoxide (DLCO) >= 50%
The following pulmonary function tests (PFT) values in baseline:\r\n* Forced expiratory volume in one second (FEV1) > 80% predicted\r\n* FEV1/forced vital capacity (FVC) > 80%\r\n* Residual volume (RV)/total lung capacity (TLV) >= 80%
Diffusing capacity of the lungs for carbon monoxide (DLCO) > 50% corrected for hemoglobin
Significant chronic obstructive pulmonary disease (COPD) or other chronic pulmonary restrictive disease with pulmonary function tests (PFTs) indicating a forced expiratory volume in one second (FEV1) less than 50% or a diffusion capacity of carbon monoxide (DLCO) less than 40% predicted for age
Diffusion capacity of carbon monoxide (DLCO) < 50% predicted (corrected for hemoglobin and alveolar volume)
Adequate pulmonary reserve defined as adequate airflow defined by a measured forced expiratory volume (FEV1) not less than 50% of the predicted value and adequate pulmonary reserve as evidenced by a FEV1/forced vital capacity (FVC) ratio of 65% or greater
FEV1 (forced expiratory volume in 1 second) >= 50% predicted
FVC (forced vital capacity) >= 50% predicted
DLCO (alveolar diffusion capacity for carbon monoxide) (corrected for hemoglobin) >= 50% of predicted
Documented forced expiratory volume 1 (FEV1) less than or equal to 60% predicted tested in patients with:\r\n* A prolonged history of cigarette smoking (20 pack [pk]/year of smoking within the past 2 years)\r\n* Symptoms of respiratory dysfunction
Pulmonary function tests (forced expiratory volume in one second [FEV1] > 65% or forced vital capacity [FVC] > 65% of predicted) within 6 months of lymphodepletion (Turnstile II)
Forced expiratory volume in one second (FEV1), forced vital capacity (FVC) and diffusing capacity of the lung for carbon monoxide (DLCO) >= 40% within 3 months of study entry (or within 1 month if received chemotherapy within the past 3 months)
Patients must have forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) > 60% by pulmonary function test (PFT), unless due to large mediastinal mass from HL; carbon monoxide diffusion capacity (DLCO), FEV1, and FVC all > 50% predicted value; all pulmonary function tests must be obtained within one month prior to registration
RANDOMIZED PHASE II (ARMS K AND L): Patients must have FEV1/FVC > 60% by pulmonary function test (PFT), unless due to large mediastinal mass from HL; carbon monoxide diffusion capacity (DLCO), FEV1, and FVC all > 50% predicted value; all pulmonary function tests must be obtained within one month prior to registration
Forced expiratory volume in 1 second (FEV1) > 65%
Diffusion capacity of the lung for carbon monoxide (DLCO) > 60%
Patients with clinically significant pulmonary dysfunction, as determined by medical history and physical exam should undergo pulmonary function testing; those with a forced expiratory volume in one second (FEV1) of < 50 % of predicted will be excluded
Diffusing capacity of the lung for carbon monoxide (DLCO) (corrected) < 40% will be excluded
Forced expiratory volume in one second (FEV1) >= 50% of expected, corrected for hemoglobin
Forced vital capacity (FVC) >= 50% of expected, corrected for hemoglobin
Diffusing capacity of the lung for carbon monoxide (DLCO) >= 50% of expected, corrected for hemoglobin
Patients requiring supplementary continuous oxygen and/or diffusion capacity of the lung of carbon monoxide (DLCO) < 40%
Forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), diffusion capacity of the lung for carbon monoxide (DLCO) > 50% predicted (corrected for hemoglobin); if unable to perform pulmonary function tests, then oxygen (O2) saturation > 92% on room air
Forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and diffusing capacity of the lungs for carbon monoxide (DLCO) >= 50% of expected, corrected for hemoglobin; for pediatric patients, if unable to perform pulmonary function tests (most children < 7 years of age), pulse oximetry >= 92% on room air by pulse oximetry
Diffusion lung capacity of oxygen (DLCO) >= 50% of predicted corrected for hemoglobin
Forced expiratory volume in 1 second (FEV1) > 65% of predicted within 6 months of lymphodepletion (Turnstile II) or
Forced vital capacity (FVC) > 65% of predicted within 6 months of lymphodepletion (Turnstile II)
Pulmonary function test (PFT) demonstrating a diffusion capacity of least 40% predicted
Active infection or other medical condition which would preclude treatment in the opinion of the principal investigator; this would include a corrected diffusing capacity of the lungs for carbon monoxide (DLCO) of < 60% predicted or symptomatic interstitial lung disease
Forced expiratory volume in one second (FEV1) >= 50%
Forced vital capacity (FVC) >= 50%
Diffusing capacity of the lung for carbon monoxide (DLCO) >= 50%
Forced expiratory volume in one second (FEV1) >= 50%
Forced vital capacity (FVC) >= 50%
Corrected diffusion capacity of the lung for carbon monoxide (DLCO) >= 50%
Adequate lung function indicated by forced expiratory volume at 1 second (FEV1) >= 1 L is required
Patients with any of the following pulmonary function abnormalities will be excluded: forced expiratory volume (FEV), < 30% predicted; diffusion capacity of the lung for carbon monoxide (DLCO), < 30% predicted (post-bronchodilator); oxygen saturation >= 92% on room air; arterial blood gas will be drawn if clinically indicated
Asymptomatic or if symptomatic, diffusing capacity of the lung for carbon monoxide (DLCO) > 50% of predicted (corrected for hemoglobin)
Pulmonary (forced expiratory volume in 1 second [FEV1] > 60% predicted and corrected diffusion capacity of the lung for carbon monoxide [DLCOcor] > 60% predicted)
Forced expiratory volume in one second (FEV1) > 65% of predicted measured, or diffusion capacity of the lung for carbon monoxide (DLCO) >= 50% of predicted measured
Documented forced expiratory volume in 1 second (FEV1) =< 60% predicted tested in patients with:\r\n* A prolonged history of cigarette smoking (>= 20 pack-year smoking history with cessation within the past two years)\r\n* Symptoms of respiratory dysfunction
Inadequate performance status/organ function defined by diffusing capacity of the lung for carbon monoxide (DLCO) < 50% (adjusted for hemoglobin [hgb]), cardiac function as defined below, Karnofsky performance status (KPS) < 60%
Hemoglobin-adjusted diffusing capacity of carbon monoxide < 40%
For all patients: diffusion capacity of the lungs for carbon monoxide (DLCO) > 40% predicted (corrected for hemoglobin [Hgb])
For patients enrolled post-P/D, only: forced expiratory volume in 1 second (FEV1) >= 35% (corrected for Hgb) (Note: patients enrolled prior to P/D will have pulmonary function tests (PFTs) repeated pre-IMRT; if this criteria is not met, they will be removed from study)
Diffusing capacity of the lung for carbon monoxide (DLCO) >= 50% of predicted corrected for hemoglobin
Adequate pulmonary function with corrected diffusion capacity of carbon monoxide (DLCO) > 50% in those for whom this study can be performed
Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) >= 45% of predicted
Patient has diffusion capacity of the lung for carbon monoxide (DLCO) < 50% predicted or forced expiratory volume in 1 second (FEV1) < 50% of predicted, if applicable
Forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) >= 40% of predicted; or in pediatric patients, if unable to perform pulmonary function tests due to young age, oxygen saturation > 92% on room air
Adequate pulmonary function with forced expiratory volume in one second (FEV1), forced vital capacity (FVC) and diffusing capacity of the lung for carbon monoxide (DLCO) >= 50% of expected corrected for hemoglobin; exceptions may be allowed for patients with pulmonary involvement after discussing with Principal Investigator (PI)
Forced expiratory volume in one second (FEV1) 40% of predicted or 3 standard deviations (SD) below normal
Forced vital capacity (FVC) 40% of predicted or 3 SD below normal
Diffusing capacity of the lung for carbon monoxide (DLCO) 40% of predicted or 3 SD below normal
Forced expiratory volume in one second (FEV1) >= 50%
Diffusing lung capacity for carbon monoxide (DLCO) >= 50%
Pulmonary: asymptomatic or if symptomatic, diffusion capacity of the lung for carbon monoxide (DLCO) >= 50% of predicted (corrected for hemoglobin)
Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), diffusion capacity of carbon monoxide (DLCO) (diffusion capacity) >= 40% predicted (corrected for hemoglobin); if unable to perform pulmonary function tests, then oxygen (O2) saturation > 92% on room air
Corrected diffusion capacity of the lungs for carbon monoxide (DLCO) < 50% of predicted, forced expiratory volume in one second (FEV1) < 50% of predicted, and/or receiving supplementary continuous oxygen; the FHCRC principal investigator (PI) of the study must approve of enrollment of all patients with pulmonary nodules
FEV1 (forced expiratory volume in the first second) >= 50% of predicted, corrected for volume and hemoglobin
FVC (forced vital capacity) >= 50% of predicted, corrected for volume and hemoglobin
DLCO (diffusing capacity of the lung for carbon monoxide) >= 50% of predicted, corrected for volume and hemoglobin
Corrected diffusion capacity of the lung for carbon monoxide (DLCO) >= 40%
Pulmonary function (spirometry and corrected diffusing capacity of the lungs for carbon monoxide [DLCO]) >= 50% predicted
Adequate pulmonary function defined as diffusion capacity of carbon monoxide (DLCO) > 30% predicted, and absence of oxygen (O2) requirements
Diffusing capacity of the lungs for carbon monoxide (DLCO) > 60% by pulmonary function test
Forced expiratory volume in 1 second (FEV1) > 60% by pulmonary function test
Forced vital capacity (FVC) > 60% by pulmonary function test
Patients must have no significant obstructive airways disease or resting hypoxemia (partial pressure of oxygen [PO2] < 80), and must have acceptable diffusion capacity (diffusion capacity of the lung for carbon monoxide [DLCO] > 50% of predicted)
Forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) >= 60% by pulmonary function test; for children who are uncooperative, no evidence of dyspnea at rest, or exercise intolerance, and must have a pulse oximetry > 94% in room air
Pulmonary function test and diffusion capacity of carbon monoxide (DLCO) > 50% of normal
Forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) < 40% predicted
Patients must have no significant obstructive airways disease (forced expiratory volume in one second [FEV1] must be >= 50% of predicted) and must have acceptable diffusion capacity (corrected diffusion capacity of carbon monoxide [DLCO] > 50% of predicted)
Patients with pre-existing severe restrictive pulmonary disease (forced vital capacity [FVC] less than 40% of predicted)
Pulmonary function tests (forced expiratory volume in one second [FEV1] > 65% or forced vital capacity [FVC] > 65% of predicted) within 6 months of lymphodepletion (Turnstile II - Chemotherapy/Cell Infusion - Inclusion Criteria)
Diffusion capacity of carbon monoxide (DLCO)corr > 50% normal
Pulmonary: diffusing capacity of the lung for carbon monoxide (DLCO) > 30% predicted, and absence of oxygen (O2) requirements; for children that are not able to cooperate with pulmonary function tests (PFTs), a pulse oximetry with exercise should be attempted; if nether test can be obtained it should be clearly stated in the physician’s note
With known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) <50% of predicted normal. Note: FEV1 testing is required for participants suspected of having COPD and participants must be excluded if FEV1 is <50% of predicted normal.
Diffusion capacity of oxygen, corrected for hemoglobin, > 50% of predicted
Pulmonary-forced expiratory volume in 1 second (FEV1) or carbon monoxide diffusing capability (DLco) < 40% or need for use of supplemental oxygen
Diffusing capacity of the lung for carbon monoxide (DLCO) > 50% predicted with no symptomatic pulmonary disease
Has the following laboratory parameters within 7 days before baseline (C1D1):Serum creatinine ?2 mg/dL; Total bilirubin ?2.0 mg/dL; Alanine transaminase (ALT) or aspartate transaminase (AST) <3.0×the upper limit of normal (ULN); Left ventricular ejection fraction (LVEF) >40%; Forced expiratory volume in 1 second (FEV1) >60% of predicted.
Pulmonary function test (PFT) demonstrating a diffusion capacity of least 45% predicted
Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g., active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol\r\n* Significant symptomatic deterioration of lung function; if clinically indicated, pulmonary function tests including measures of predicted lung volumes, carbon monoxide diffusing capacity (DLco), oxygen (O2) saturation at rest on room air should be considered to exclude pneumonitis or pulmonary infiltrates
FEV1 and corrected DLCO of 35% or > of predicted.
Pulmonary function tests diffusing capacity of the lungs for carbon monoxide (DLCO) (adjusted for hemoglobin) > 50% predicted
Subject has known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) < 50% predicted normal; Note that FEV1 testing is required for patients suspected of having COPD and subjects must be excluded if FEV < 50%
Forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) >= 65% of predicted (patients >= 40 years old)
Documented forced expiratory volume in 1 second (FEV1) less than or equal to 60% predicted tested in patients with:\r\n* A prolonged history of cigarette smoking (20 packs [pk]/year of smoking within the past 2 years).\r\n* Symptoms of respiratory dysfunction
Clinically significant pulmonary dysfunction, as determined by medical history and physical exam. Patients so identified will undergo pulmonary functions testing and those with forced expiratory volume in 1 second (FEV1) < 2.0 L or carbon monoxide diffusing capability (DLco) (correlation for hemoglobin [corr for Hgb]) < 75% will be excluded.
Pulmonary function: diffusing capacity of the lungs for carbon monoxide (DLCO), forced expiratory volume in one second (FEV1), forced vital capacity (FVC) > 50% of predicted value (corrected for hemoglobin) within 3 months of registration.
Carbon monoxide diffusing capability (DLCO) corrected >= 60% normal (may not be on supplemental oxygen)
Clinically significant pulmonary dysfunction, as determined by medical history and physical exam. Patients so identified will undergo pulmonary functions testing and those with forced expiratory volume in one second (FEV1) < 60% of normal or carbon monoxide diffusing capacity (DLco) (corrected [corr] for hemoglobin [Hgb]) < 55% will be excluded.
Forced expiratory volume in one second (FEV1), forced vital capacity (FVC) and carbon monoxide diffusing capacity (DLCOc) >= 50% of predicted).
Subject has known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) < 50% of predicted normal. NOTE: FEV1 testing is required for patients suspected of having COPD and subjects must be excluded if FEV1 < 50% of predicted normal
Diffusion capacity of the lung for carbon monoxide (DLCO) > 40% with no symptomatic pulmonary disease
Corrected diffusion capacity of the lung for carbon monoxide (DLCOcorr) > 50% ULN
Pulmonary function (diffusion capacity of the lung for carbon monoxide [DLCO]) > 40% of the expected value corrected for alveolar volume and hemoglobin
Patients with any of the following pulmonary function abnormalities will be excluded: forced expiratory volume (FEV), < 30% predicted; diffusion capacity of the lung for carbon monoxide (DLCO), < 30% predicted (post-bronchodilator); partial pressure of oxygen (pO2) < 60 mm Hg or partial pressure of carbon dioxide (pCO2) >= 55 mm Hg on room air arterial blood gas
Pulmonary disease: forced vital capacity (FVC) < 60% predicted
Pulmonary disease: forced expiratory volume in 1 second (FEV1) < 60% predicted
Pulmonary disease: diffusion capacity of the lung for carbon monoxide (DLCO) parameters < 60% predicted (corrected for hemoglobin)
> 50% corrected diffusing capacity of the lung for carbon monoxide (DLCO), if presence of pleural effusion due to metastatic disease > 40% corrected DLCO is acceptable (within 28 days of treatment start)
> 50% forced expiratory volume of the lung in 1 second (FEV1), if presence of pleural effusion due to metastatic disease > 40% corrected FEV1 is acceptable (within 28 days of treatment start)
Lung diffusion capacity >= 50%
Severe chronic obstructive lung disease, or symptomatic restrictive lung disease, or corrected diffusing capacity of the lungs for carbon monoxide (DLCO) of < 40% of predicted
Normal lung function; patients who have extensive pulmonary metastases or any chronic pulmonary disease history must have pulmonary function testing demonstrating forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) > 65% of predicted values
Within 30 days of registration: Corrected carbon monoxide diffusing capability (DLCO) and forced expiratory volume in 1 second (FEV1), >= 60% predicted
Forced expiratory volume >= 1.0 L or >= 40% of predicted with or without bronchodilators by pulmonary function testing
Patients with any of the following pulmonary function abnormalities: forced expiratory volume (FEV), < 30% predicted; diffusion capacity of the lungs for carbon monoxide (DLCO) < 30% predicted (post-bronchodilator); oxygen saturation less than 92% on room air
Patients with pre-existing severe restrictive pulmonary disease (forced vital capacity [FVC] less than 60% of predicted)
Carbon monoxide diffusing capacity (DLCO; corrected for hemoglobin [Hgb]) >= 50% of predicted value
Forced expiratory volume in 1 second (FEV1) >= 50% of predicted value
Forced expiratory vital capacity (FVC) >= 50% of predicted value
Spirometry diffusion capacity (diffusion capacity of the lung for carbon monoxide [DLCO]) >= 50%
Diffusion capacity of carbon monoxide (DLCO) >= 30% predicted, no oxygen (O2) requirements
Pulmonary function: oxygen saturation >= 90% on room air and pulmonary function > 50% corrected diffusion capacity of the lung for carbon monoxide (DLCO) and forced expiratory volume in 1 second (FEV1) testing required only if symptomatic or prior known impairment
Clinically significant pulmonary dysfunction, as determined by medical history and physical examination; patients with a history of pulmonary dysfunction must have pulmonary function tests with a forced expiratory volume in 1 second (FEV1) >= 60% of predicted and a diffusing capacity of the lung for carbon monoxide (DLCO) >= 55% (corrected for hemoglobin)
Forced expiratory volume in one second (FEV1) >= 50% predicted
Forced vital capacity (FVC) (corrected for hemoglobin) >= 50% predicted
Carbon monoxide diffusing capability test (DLCO) (corrected for hemoglobin) >= 50% predicted
Forced expiratory volume in one second (FEV1) >= 50% of predicted value (corrected to serum hemoglobin)
Forced vital capacity (FVC) >= 50% of predicted value (corrected to serum hemoglobin)
Diffusing capacity for carbon monoxide (DLCO) >= 50% of predicted value (corrected to serum hemoglobin)
Diffusing capacity of the lung for carbon monoxide (DLCO) or forced expiratory volume in 1 second (FEV1) > 45% predicted
Significant chronic obstructive pulmonary disease (COPD) or other chronic pulmonary restrictive disease with pulmonary function tests (PFTs) indicating an forced expiratory volume in 1 second (FEV1) less than 50% or a diffusion capacity of the lung for carbon monoxide (DLCO) less than 40% predicted for age; Note: patients who have shortness of breath with minimal exertion or who are at risk for pulmonary disease (e.g., chronic smokers) will undergo pulmonary function testing and will not be eligible if their FEV1 is < 50% of expected
Diffusing capacity of the lungs for carbon monoxide (DLCO), forced expiratory volume in one second (FEV1), forced vital capacity (FVC) > 50%\r\n* DLCO should be corrected for hemoglobin
Diffusing capacity of the lung for carbon monoxide (DLCO) >= 50% of predicted value (corrected for hemoglobin)
Other serious medical conditions considered to represent contraindications to ASCT (e.g., abnormally decreased cardiac ejection fraction, diffusion capacity of the lung for carbon monoxide [DLCO] < 50% predicted, acquired immune deficiency syndrome [AIDS], etc.)
Pulmonary function tests (forced expiratory volume in one second [FEV1] > 65% or forced vital capacity [FVC] > 65% of predicted are required) within 6 months of lymphodepletion in those who have a history of pulmonary disease that necessitates the use of supplemental oxygen, or is associated with dyspnea on walking one block or less, or requires inhaler therapy more than once per week
Pulmonary function tests, including diffusion capacity of carbon monoxide (DLCO), within 6 weeks prior to registration; patients must have forced expiratory volume in 1 second (FEV1) >= 1.2 Liter or >= 50% predicted without bronchodilator
Lung diffusion capacity for carbon monoxide (DLCO) > 50%, or forced expiratory volume at 1.0 seconds (FEV1.0) > 65% of predicted on pulmonary function testing (PFT) obtained within 28 days of study enrollment
Diffusing capacity of the lung for carbon monoxide (DLCO) >= 40% of the expected value corrected for alveolar volume and hemoglobin (hgb) for reduced intensity transplant and DLCO >= 55% for myeloablative regimen; for children who are unable to cooperate for pulmonary function tests (PFTs), the criterion is, no evidence of dyspnea at rest, no exercise intolerance, and no requirement for supplemental oxygen therapy
Severely impaired lung function as defined as spirometry and diffusing capacity of the lungs for carbon monoxide (DLCO) that is < 50% of the normal predicted value and/or oxygen (02) saturation that is 88% or less at rest on room air
Corrected diffusing capacity of the lung for carbon monoxide (DLCO) greater than or equal to 50% on pulmonary function tests
Diffusing capacity of the lung for carbon monoxide (DLCO), forced expiratory volume in one second (FEV1), and forced vital capacity (FVC) >= 50% of predicted (corrected for hemoglobin)
Adequate pulmonary function based on the following pulmonary function tests done within 8 weeks of registration:\r\n* Forced expiratory volume (FEV)1 at least 2.0 liters; if less than 2.0 liters, the predicted post-resection FEV1 must be at least 0.8 liters \r\n* Diffusion capacity should be >= 50% predicted
Patients with a diffusion capacity of the lung for carbon monoxide (DLCO) < 50% of normal or
Forced expiratory volume in 1 second (FEV1) < 50% of normal
Other serious medical conditions considered to represent contraindications to bone marrow transplant (BMT) (e.g. abnormally decreased cardiac ejection fraction, diffusion capacity of the lung for carbon monoxide (DLCO) < 50% predicted, forced expiratory volume in one second (FEV1) < 70% predicted, acquired immune deficiency syndrome [AIDS], etc.)
Patients must have no significant obstructive airways disease (forced expiratory volume in 1 second [FEV1] must be >= 50%) and must have acceptable diffusion capacity (corrected diffusion capacity of the lung for carbon monoxide [DLCO] > 50% of predicted)
Patients with a diffusing capacity of the lung for carbon monoxide (DLCO) < 55% of normal or a forced expiratory volume in one second (FEV1) < 60% of normal, based on either NIH or United States (USA) normal ranges
Corrected diffusion capacity of the lung for carbon monoxide (DLCO) > 45% of expected value
Respiratory compromise, defined as ventilation tests with diffusion capacity of the lung for carbon monoxide (DLCO) < 50%
Adequate pulmonary function with diffusing capacity of the lung for carbon monoxide (DLCO) > 50%
Poor pulmonary function: \r\n* For patients receiving a TBI based preparative regimen: forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and diffusing capacity of the lung for carbon monoxide (DLCO) (corrected for hemoglobin [Hgb]) =< 60% by pulmonary function tests (PFTs)\r\n* For patients receiving a non-TBI based preparative regimen: FEV1, FVC, and DLCO =< 50% predicted (corrected for hemoglobin) for patients who have not received thoracic or mantle irradiation\r\n* For patients who have received thoracic or mantle irradiation, FEV1 and FVC < 70% predicted or DLCO =< 50 of predicted; for children unable to perform PFTs because of developmental stage pulse oximetry =< 92% on room air (RA): no evidence of dyspnea at rest, no exercise intolerance\r\n* For children who are unable to cooperate for PFTs, required criteria are: no evidence of dyspnea at rest, no exercise intolerance, and not requiring supplemental oxygen therapy
Known chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (FEV1) less than (<)50 percent (%) of predicted normal
Diffusion lung capacity for carbon monoxide (DLCO) adjusted for hemoglobin >= 60% predicted, except if related to high volume metastatic GCT to the lungs, in which case there is no minimum DLCO requirement; in some cases, patients may not be able to undergo pulmonary function test (PFT) testing due to the severity of their presentation, such as those with high volume lung metastases or tumor-related pain (from large mediastinal masses, pleural disease, etc.) limiting their ability to complete PFTs; even when PFTs can be completed in these cases, patients will still be eligible if the low DLCO can be attributed directly to the patient's disease (e.g. large mediastinal mass) rather than intrinsic lung disease; since there is no minimum DLCO for these patients, under these extraordinary circumstances, this will be allowed; most patients in this situation will be expected to receive disease-stabilizing chemotherapy; an unadjusted DLCO may be used in place of the DLCO adjusted for hemoglobin in certain situations as per institutional policy; for example, MSKCC policy is to not adjust the DLCO for hemoglobin when the hemoglobin is >= 14.6 g/dL for males and >= 13.4 g/dL for females; in these cases, the unadjusted DLCO must be >= 60% predicted
Idiopathic interstitial pneumonia or impaired diffusion capacity of the lung for carbon monoxide (DLCO).
Has chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) 50% of predicted normal
Any known uncontrolled underlying pulmonary disease by history, physical exam or if applicable pulmonary function tests (PFTs) (e.g. forced expiratory volume in 1 second [FEV1] or carbon monoxide diffusing capability [DLCO] 50% or less of predicted or oxygen [O2] saturation 88% or less at rest on room air)
Patients must have pulmonary function tests (PFTs) including forced expiratory volume in 1 second (FEV1) within 84 days prior to registration; for FEV1, the best value obtained pre- or post-bronchodilator must be >= 1.2 liters/second and/or >= 50% predicted
Patients must not have any known uncontrolled underlying pulmonary disease (e.g. forced expiratory volume in 1 second [FEV1] or diffusion capacity of the lung for carbon monoxide [DLCO] 50% or less of predicted OR oxygen [O2] saturation 88% or less at rest on room air)
Symptomatic chronic obstructive lung disease, symptomatic restrictive lung disease, or corrected diffusing capacity of the lung for carbon monoxide (DLCO) of < 50% of predicted, corrected for hemoglobin
DLCO > 50 percent predicted
Forced Expiratory Volume at one second (FEV1) > 1.2 liters; Diffusion Capacity of Lung for Carbon Monoxide (DLCO) ? 50% predicted
Diffusing capacity of carbon monoxide (DLCO) corrected for hemoglobin > 50%
Inadequate pulmonary function with mechanical parameters < 40% predicted (FEV1, FVC, TLC, DLCO).
Diffusing capacity of the lungs for carbon monoxide (DLCO) (corrected for hemoglobin) =< 50%
Forced expiratory volume in one second (FEV1) with >= 1200 cc or >= 50% predicted
Diffusion capacity of the lung for carbon monoxide (DLCO) < 40% (corrected), total lung capacity (TLC) < 40%, forced expiratory volume in one second (FEV1) < 40% and/or receiving supplementary continuous oxygen
Adequate lung function; forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV1) ? 45% of predicted value as measured by spirometry; and oxygen saturation ? 90% on room air
Patients must be considered a candidate for surgical resection of the primary tumor; standard justification for deeming a patient medically operable based on pulmonary function for surgical resection of non-small cell lung cancer (NSCLC) may include any of the following: baseline forced expiratory volume in 1 second (FEV1) > 40% predicted, post-operative predicted FEV1 > 30% predicted, diffusion capacity > 40% predicted, absent baseline hypoxemia and/or hypercapnia, exercise oxygen consumption > 50% predicted, absent severe pulmonary hypertension, absent severe cerebral, cardiac, or peripheral vascular disease, and absent severe chronic heart disease
Forced expiratory volume of the lung in 1 second (FEV1) >= 40% predicted
Forced vital capacity (FVC) >= 40% predicted
Corrected diffusing capacity of the lung for carbon monoxide (DLCOc) >= 40% predicted; if DLCO is < 40%, patients will still be considered eligible if deemed safe after a pulmonary evaluation
Other serious medical conditions considered to represent contraindications to ASCT (e.g., abnormally decreased cardiac ejection fraction, diffusion capacity of carbon monoxide [DLCO] < 50% predicted, etc.)
Pulmonary function tests (PFTs) are required of all patients within 4 months prior to lymphodepletion; forced expiratory volume (FEV)1 and forced vital capacity (FVC) must be >= 65% predicted and diffusion lung capacity for carbon monoxide (DLCO) must be >= 50% predicted
FEV1 < 65% predicted, FVC < 65% of predicted, DLCO (corrected for hemoglobin [Hgb]) < 50% predicted); pulmonary function tests (PFTs) within 4 months prior to consent for Step I will be required for patients with underlying risk factors such as smoking history > 10 pack years, or a history of pre-existing symptomatic lung disease (not including melanoma metastases to the lung)
Clinically significant pulmonary dysfunction (FEV1< 65% predicted or FVC < 65% of predicted, DLCO (corrected for Hgb) < 50% predicted)
Pulmonary diffusion capacity > 25% lower than normal predicted value
Diffusion capacity of the lung for carbon monoxide (DLCO), forced expiratory volume in one second (FEV1), forced vital capacity (FVC) >= 50% of predicted value (corrected for hemoglobin) within 3 months of registration
Adequate pulmonary function with forced expiratory volume in one second (FEV1), forced vital capacity (FVC) and diffusion capacity of the lung for carbon monoxide (DLCO) >= 50% of expected corrected for hemoglobin
Pulmonary: diffusing capacity of the lungs for carbon monoxide (DLCO), forced expiratory volume (FEV1), forced vital capacity (FVC) ? 50% predicted by pulmonary function tests (PFTs)
Subject has known pulmonary disease with diffusion capacity of lung for carbon monoxide (DLCO) ? 65%, forced expiratory volume in the first second (FEV1) ? 65%, dyspnea at rest or requiring oxygen or any pleural neoplasm (Transient use of supplemental oxygen is allowed.)
Forced expiratory volume in one second (FEV1) and diffusion capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) >= 50% predicted
Primary tumor must be technically resectable by an experienced thoracic cancer clinician, with a reasonable possibility of obtaining a gross total resection with negative margins (potentially curative resection, [PCR]); however, patients must have underlying physiological medical problems prohibiting PCR (i.e., problems with general anesthesia, the operation, the post-operative (op) recovery period, or removal of adjacent functioning lung) or refuse surgery; deeming a patient medically inoperable based on pulmonary function for surgical resection may include any of the following: baseline forced expiratory volume in one second (FEV1) < 40% predicted; post-operative predicted FEV1 < 30% predicted; severely reduced diffusion capacity; baseline hypoxemia and/or hypercapnia; exercise oxygen consumption < 50% predicted; severe pulmonary hypertension; diabetes with severe end organ damage; severe cerebral, cardiac, or peripheral vascular disease; or severe chronic heart disease; any of these problems will qualify a patient for this trial
Forced expiratory volume in one second (FEV1) AND forced vital capacity (FVC) > 50% predicted
Diffusing capacity of the lung for carbon monoxide (DLCO) (corrected) > 50% predicted; if the corrected DLCO is not able to be calculated, principal investigator (PI) must be contacted
Forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) >= 40% of predicted; or if unable to perform pulmonary function tests due to young age, oxygen saturation > 92% on room air
Clinically significant pulmonary dysfunction, as determined by medical history and physical exam. Patients so identified will undergo pulmonary functions testing and those with forced expiratory volume in one second (FEV1) < 2.0 L or diffusion lung capacity [DLCO] corrected [corr] for hemoglobin [Hgb]) < 50% will be excluded.
Diffusing capacity for carbon monoxide (DLCO) >= 45% predicted corrected for hemoglobin; for children =< 7 years of age who unable to perform the pulmonary function test, an oxygen (O2) saturation of >= 92% on room air
Clinically significant pulmonary dysfunction, as determined by medical history and physical exam; patients so identified will undergo pulmonary functions testing and those with forced expiratory volume in 1 second (FEV1) < 2.0 L or diffusion capacity of the lungs for carbon monoxide (DLCO) (corrected for Hb) < 50% will be excluded
Forced expiratory volume in one second (FEV1) >= 50% or diffusing capacity of the lungs for carbon monoxide (DLCO) (hemoglobin [Hb]) >= 40% of predicted, unless pulmonary dysfunction is deemed to be due to chronic GVHD
Forced expiratory volume in 1 second (FEV1) >= 50% or diffusion capacity of the lung for carbon monoxide (DLCO) (hemoglobin [Hb]) >= 40% of predicted, unless pulmonary dysfunction is deemed to be due to chronic GVHD; for pediatric patients < 7 years old, pulmonary function testing will not be required; rather, pediatric patients < 7 years old who have pulmonary symptoms will be evaluated by a pulmonologist
Patients with significant, symptomatic deterioration of lung function confirmed by spirometry, diffusion capacity of the lungs for carbon monoxide (DLCO), or resting oxygen (O2) saturation
Pulmonary function tests (PFTs) with diffusing capacity of the lung for carbon monoxide (DLCO) are conditional for subjects at the discretion of the physician; the required minimum standards for those who have PFTs include DLCO of 40%; those with DLCO of 40-49% must have a pulmonologist consult and assist with management
Patients who would be receiving SBRT for lung tumors who are known or suspected by the treating radiation oncologist to have compromised lung function must have a documented forced expiratory volume in 1 second (FEV1) >= 1 L
Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) >= 50 % of predicted
Forced expiratory volume in one second (FEV-1) >= 50%
Has known chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (FEV1) < 50% of predicted normal (note that FEV1 testing is required for subjects suspected of having chronic obstructive pulmonary disease and subjects must be excluded if FEV1 < 50% of predicted normal)
Patients who can perform pulmonary function tests will be excluded if they have a diffusing capacity of the lung for carbon monoxide (DLCO) (corrected for hemoglobin) of < 60% predicted; patients who are unable to perform pulmonary function tests (for example, due to young age and/or developmental status) will be excluded if the oxygen (O2) saturation is < 92% on room air
Participants must have adequate pulmonary function studies (PFTs), >= 50% of predicted on mechanical aspects (forced expiratory volume in 1 second [FEV^1], forced vital capacity [FVC]) and diffusion capacity (diffusion capacity of the lung for carbon monoxide [DLCO]) >= 50% of predicted (adjusted for hemoglobin); if the participant is unable to complete pulmonary function tests (PFTs) due to disease-related pain or other circumstances that make it difficult to reliably perform PFTs, documentation of pulmonary function adequate for transplant will occur via a CT scan without evidence of major pulmonary disease, and arterial blood gas results
Forced expiratory volume in 1 second (FEV1) >= 50%
Forced vital capacity (FVC) >= 50%
Adequate pulmonary function as assessed by diffusion capacity of the lung for carbon monoxide (DLCO) of >= 45% adjusted for hemoglobin
Diffusing capacity of the lung for carbon monoxide (DLCO) < 50% corrected for hemoglobin
Patients with significant impairment of pulmonary function on account of chronic bronchitis, emphysema or chronic obstructive pulmonary disease (COPD) which has resulted in impairment of vital capacity of forced expiratory volume in one second (FEV1) to less than 75% of predicted normal values
Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g., active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol\r\n* Significant symptomatic deterioration of lung function; if clinically indicated, pulmonary function tests including measures of predicted lung volumes, diffusing capacity of the lung for carbon monoxide (DLCO), oxygen (O2) saturation at rest on room air should be considered to exclude pneumonitis or pulmonary infiltrates
Forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) > 60% by pulmonary function test (PFT), unless due to large mediastinal mass from HL; carbon monoxide diffusion capacity (DLCO), FEV1, and forced vital capacity all > 50% predicted value; Note: pulmonary function testing is not required for children < 8 years old, or for any child who is developmentally unable to comply with pulmonary function testing
Asymptomatic or if symptomatic, diffusing capacity of the lung for carbon monoxide (DLCO) > 50% of predicted (corrected for hemoglobin)
Forced expiratory volume in 1 second (FEV1) >= 50%
Forced vital capacity (FVC) >= 50%
Diffusing capacity of the lung for carbon monoxide (DLCO) >= 40% of predicted (corrected for hemoglobin)
Diffusing capacity of the lungs for carbon monoxide (DLCO) (corrected for hemoglobin > 40%; and forced expiratory volume in one second (FEV1) > 50%
Diffusing capacity of the lung for carbon monoxide (DLCO) corrected > 60% normal
Spirometry (forced expiratory volume in one second [FEV1] and forced vital capacity [FVC]) & corrected diffusing capacity of lungs for carbon monoxide (DLCO) >= 50% predicted; in small children use history and physical computed tomography (CT) scan to determine pulmonary status
Subjects with asymptomatic pulmonary function based on lung diffusion testing diffusion capacity of the lung for carbon monoxide (DLCO) test; DLCO >= 50% of predicted (corrected for hemoglobin)
Diffusion capacity of the lung for carbon monoxide (DLCO) >= 30% predicted within 6 weeks prior to study enrollment; no oxygen (O2) requirements
Pulmonary: asymptomatic or if symptomatic, diffusion lung capacity of carbon monoxide (DLCO) > 40% of predicted (corrected for hemoglobin)
Forced vital capacity (FVC) >= 50% predicted
Adequate pulmonary function with forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and diffusion capacity of the lung for carbon monoxide (DLCO) >= 50% of expected corrected for hemoglobin and/or volume; children unable to perform pulmonary function tests (e.g., less than 7 years old) pulse oximetry of >= 92% on room air
Diffusing capacity of the lung for carbon monoxide (DLCO)/alveolar volume (VA) and forced expiratory volume in 1 second (FEV-1.0) >= 60% of predicted on pulmonary function tests
Forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) >= 60% and corrected diffusion capacity of the lung for carbon monoxide (DLCO) >= 60%
Hepatic: i. Total Bilirubin < 2.0 mg/dL (except for isolated hyperbilirubinemia attributed to Gilbert syndrome or antiretroviral therapy as specified in Appendix E) and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 5x the upper limit of normal. ii. Concomitant Hepatitis: Patients with chronic hepatitis B or C may be enrolled on the trial providing the above bilirubin and transaminase criteria are met. In addition, there must be no clinical or pathologic evidence of irreversible chronic liver disease, and there must be no active viral replication as evidenced by an undetectable hepatitis viral load by a PCR-based assay. c) Renal: Creatinine clearance (calculated creatinine clearance is permitted) > 40 mL/min. d) Pulmonary: Diffusing capacity of the lung for carbon monoxide (DLCO), forced expiratory volume in one second (FEV1), or forced vital capacity (FVC) ? 45% of predicted (corrected for hemoglobin).
Diffusion lung capacity of carbon monoxide (DLCO) < 40% predicted
Pulmonary function > 50% corrected diffusing capacity of the lungs for carbon monoxide (DLCO)
Forced expiratory volume in one second (FEV1) testing required only if symptomatic or prior known impairment
Pulmonary function of diffusing capacity of the lung for carbon monoxide (DLCO) adjusted for alveolar volume (adj/VA) and forced expiratory volume in one second (FEV1) >= 60% of normal indices for age and height unless the patient has a likely acute reversible etiology of decline and then DLCO adj/VA >= 30% of normal; pediatric patients unable to complete pulmonary function tests (PFTs) may be enrolled as per enrolling institution standard operating procedure (SOP) for recipient guidelines
Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g., active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol\r\n* Significant symptomatic deterioration of lung function; if clinically indicated, pulmonary function tests including measures of predicted lung volumes, diffusing capacity of the lung for carbon monoxide (DLco), oxygen (02) saturation at rest on room air should be considered to exclude pneumonitis or pulmonary infiltrates
Corrected diffusion lung capacity of carbon monoxide (DLCO) < 35% or receiving supplemental continuous oxygen
Diffusing capacity of carbon monoxide >= 50% of predicted
Diffusing capacity of the lung for carbon monoxide (DLCO) < 40%, total lung capacity (TLC) < 40%, forced expiratory volume in one second (FEV1) < 40% and/or receiving supplementary continuous oxygen
Must have adequate lung function defined within 150 days prior to registration as: (1) forced expiratory volume in 1 second (FEV1) > 30% of predicted or > 800 ml, (2) diffusing capacity of the lung for carbon monoxide (DLCO) > 30 % predicted
Decrease in FEV1 of >= 12% from the baseline (FEV1/forced vital capacity [FVC] ratio < 0.8); NOTE: baseline may be defined as either pre- or post-transplant, as assessed by the treating physician
Pulmonary: asymptomatic or if symptomatic, diffusion capacity of carbon monoxide (DLCO) > 50% of predicted (corrected for hemoglobin)
Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted) > 50%
Forced expiratory volume in 1 second (FEV1) >= 1 liter
Forced expiratory volume in 1 second (FEV1) >= 2.0 liters or >= 75% of predicted for height and age; (pulmonary function tests [PFTs] are required for patients over 50 or with significant pulmonary or smoking history)
Subjects with clinical signs of pulmonary insufficiency must have diffusion capacity of the lung for carbon monoxide (DLCO) to be measured at >= 50% of predicted value
Patients must also have a resting multi gated acquisition scan (MUGA) (preferred) or echocardiogram (ECHO) and pulmonary function tests (PFTs) with diffusing capacity of the lung for carbon monoxide (DLCO) performed before transplant and found to be acceptable according to the treating institution’s guidelines; recommended minimum standards include an ejection fraction (EF) greater than 35% and corrected DLCO greater than 35% for this less toxic regimen; if lower than this, single patient exemption may be sought
Patients with active pulmonary infection and/or pulse oximetry < 90% and a corrected diffusion capacity of the lung for carbon monoxide (DLCO) < 70% of predicted
Corrected diffusion capacity of carbon monoxide (DLCO) < 35% and/or receiving supplemental continuous oxygen
Diffusion capacity of the lung for carbon monoxide (DLCO) > 50% of the expected value when corrected for hemoglobin (Hb), obtained within 28 days of enrollment
Diffusing capacity of the lung for carbon monoxide (DLCO) < 40%, total lung capacity (TLC) < 40%, forced expiratory volume in 1 second (FEV1) < 40% and/or requiring continuous supplementary oxygen, or severe deficits in pulmonary function testing as defined by pulmonary consultant service; and the FHCRC principal investigator (PI) of the study must approve of enrollment of all patients with pulmonary nodules
Pulmonary dysfunction as measured by a corrected diffusing capacity of the lung for carbon monoxide (DLCO) < 50% of predicted total lung capacity (TLC) < 30%, forced expiratory volume in 1 second (FEV1) < 30% and/or receiving supplementary continuous oxygen; the FHCRC principal investigator (PI) of the study must approve enrollment of all patients with pulmonary nodules
History of clinically significant pulmonary fibrosis or documented diffusing capacity of the lung for carbon monoxide <50% predicted
Pulmonary: asymptomatic or if symptomatic, diffusing capacity of the lungs for carbon monoxide (DLCO) > 50% of predicted (corrected for hemoglobin)
Forced expiratory volume in 1 second (FEV1) > 60% and diffusion capacity of the lung for carbon monoxide (DLCO) > 50% of predicted lower limit
Forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) >= 50% of predicted (for patients who have not received thoracic or mantle irradiation; for patients who have received thoracic or mantle irradiation, FEV1 and FVC >= 70% of predicted
Pulmonary function tests as follows: diffusion capacity of the lungs for carbon monoxide (DLCO) > 50% predicted
Carbon monoxide diffusing capacity (DLCO) >= 50% of predicted corrected for hemoglobin
Pulmonary function tests (PFT)-forced expiratory volume in one second (FEV1), diffusing capacity of the lung for carbon monoxide (DLCO2), and forced vital capacity (FVC) >= 60% predicted value if clinically indicated
Corrected diffusion capacity of the lung for carbon monoxide (DLCO) equal or above 50% of expected
Restrictive lung diseases due to parenchymal damage (eg idiopathic lung fibrosis) or pleural adhesions. Patients with lung resection, scoliosis or thorax malformations can be included provided adequate spirometry testing during screening (eg FEV-Forced expiratory volume 1 ? 70%; age, sex and height adapted vital capacity)
Abnormal lung diffusion capacity (diffusing capacity of the lungs for carbon monoxide [DLCO] < 40% predicted)
Subjects > 10 years: DLCO (diffusion capacity) > 50% of predicted (corrected for hemoglobin)
Significant symptomatic deterioration of lung function; if clinically indicated, pulmonary function tests including measures of predicted lung volumes, diffusing capacity of the lung for carbon monoxide (DLco), oxygen (O2) saturation at rest on room air should be considered to exclude pneumonitis or pulmonary infiltrates
Patients be able to undergo VATS resection as defined below:\r\n* Preoperative forced expiratory volume in 1 second (FEV1) >= 40% predicted OR\r\n* Post-operative predicted FEV1 >= 0.8 l\r\n* Mercury (Hg) >= 8.0\r\n* No evidence of coronary ischemia on cardiac evaluation per institutional standard (ie. cardiology evaluation, stress test, etc.)
Forced expiratory volume in one second (FEV1) of >= 1 liter and diffusion capacity of carbon monoxide (DLCO) >= 40% of predicted
Pulmonary function test (PFT) demonstrating a diffusion capacity of least 50% predicted, corrected for hemoglobin
Clinically significant pulmonary dysfunction, as determined by medical history and physical exam; patients so identified will undergo pulmonary functions testing and those with forced expiratory volume in one second (FEV1) < 2.0 L or diffusing capacity of the lung for carbon monoxide (DLCO) (corrected for hemoglobin [Hgb]) < 50% will be excluded
Forced expiratory volume in one second (FEV1) must be >= 1.0 L
Patients with significant impairment of pulmonary function on account of chronic bronchitis or chronic obstructive pulmonary disease (COPD) which has resulted in impairment of vital capacity of forced expiratory volume in one second (FEV1) to less than 75% of predicted normal values
Forced expiratory volume (FEV) < 30% predicted
Diffusion capacity of the lung for carbon monoxide (DLCO) < 30% predicted (post-bronchodilator)
Pulmonary function: > 40% corrected diffusing capacity of carbon monoxide (DLCO) and forced expiratory volume in one second (FEV1) (oxygen saturation [> 92%] can be used in child where pulmonary function tests [PFT's] cannot be obtained)
Corrected diffusing capacity of the lung for carbon monoxide (DLCOcorr) > 50% of normal, (oxygen saturation [> 92%] can be used in child where pulmonary function tests [PFT’s] cannot be obtained)
Patients with prior smoking history or emphysema will require diffusion lung capacity for carbon monoxide (DLCO) of >= 80% of predicted value for age
FEV1, FVC and corrected DLCO > 40%.
Diffusing capacity of the lungs for carbon monoxide (DLCO) <60% of the predicted values
Forced expiratory volume in 1 second (FEV1) > 2.0 liters or > 75% of predicted for height and age; pulmonary function tests (PFTs) are required for patients over 50 years old or with significant pulmonary or smoking history
Forced vital capacity (FVC), forced expiratory volume in one second (FEV1) or diffusion capacity of carbon monoxide (DLCO) > 50% predicted- before admission for transplant as per institutional standards; patients on home oxygen are not allowed on the protocol
Greater than or equal to (>=) 75 years of age or >= 65 up to 75 years of age and have at least one of the following: congestive heart failure or ejection fraction less than or equal to (<=) 50 percent; creatinine greater than (>) 2 milligram per deciliter (mg/dL); dialysis or prior renal transplant; documented pulmonary disease with lung diffusing capacity for carbon monoxide (DLCO) <= 65 percent of expected, or forced expiratory volume in 1 second (FEV1) <= 65 percent of expected or dyspnea at rest requiring oxygen; eastern cooperative oncology group (ECOG) performance status of 2; prior or current malignancy that does not require concurrent treatment; unresolved infection; comorbidity that, in the Investigator's opinion, makes the participant unsuitable for intensive chemotherapy and must be documented and approved by the Sponsor before randomization
Diffusing capacity of the lungs for carbon monoxide (DLCO) >= 40%
Forced expiratory volume (FEV) =< 1.2 L/s
Forced expiratory volume of the lung in one second (FEV1) > 40% of predicted at the screening visit
Forced vital capacity (FVC) > 40% of predicted at the screening visit
Forced expiratory volume in one second (FEV1) >= 50% of expected corrected for hemoglobin
Forced vital capacity (FVC) >= 50% of expected corrected for hemoglobin
Diffusing capacity of the lung for carbon monoxide (DLCO) >= 50% of expected corrected for hemoglobin
Forced expiratory volume in 1 second (FEV1) > 50% of predicted and diffusing capacity of the lung for carbon monoxide (DLCO) >= 50% of predicted
Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and adjusted diffusing capacity of the lungs for carbon monoxide (DLCO) >= 50% of predicted values on pulmonary function tests
Current severely impaired lung function (i.e., forced expiratory volume in 1 second [FEV1] < 1 liter)
Chest x-ray (CXR) or computed tomography CT within 4 weeks prior to Day 1 with no evidence of pulmonary congestion, pleural effusions, pulmonary fibrosis, or significant emphysema. If results are questionable, patients should have additional lung function testing to exclude clinically relevant restriction or obstruction. Patients must have a forced expiratory volume (FEV-1) and Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) of at least 65% and 50% of expected, respectively.
Diffusion capacity of carbon monoxide (DLco) <50% of predicted (corrected for hemoglobin).
Patient pulmonary function showed that pre-bronchial dilator FEV1 < 25% or diffusing capacity of the lung for carbon monoxide (DLCO) < 25%
Forced expiratory volume in 1 second (FEV1) >= 40% of predicted
Forced vital capacity (FVC) >= 40% of predicted
Forced expiratory volume (FEV) 1 > 2.0 liters or > 75% of predicted for height and age (pulmonary function test [PFTs] are required for patients over 50 years old or with significant pulmonary or smoking history)
Diffusion capacity of the lung for carbon monoxide (DLCO)/DLCO corrected for alveolar volume (VA) and forced expiratory volume in one second (FEV-1.0) > 50% of predicted on pulmonary function tests
Diffusing capacity of the lungs for carbon monoxide (DLCO) >= 45% predicted corrected for hemoglobin; for pediatric patients, if unable to perform pulmonary function, >= 92% oxygen saturation with pulse oximetry
Adequate pulmonary function with forced expiratory volume in one second (FEV1), forced vital capacity (FVC) and diffusing capacity of the lung for carbon monoxide (DLCO) at least 45% of expected corrected for hemoglobin; children unable to perform pulmonary functions must have an oxygen saturation greater than 92% at room air
Diffusing capacity of the lung for carbon monoxide (DLCO) > 50% of expected value (hemoglobin [Hb] corrected), obtained within 28 days of enrollment
Forced expiratory volume in one second (FEV1), forced vital capacity (FVC) and corrected diffusing capacity of the lung for carbon monoxide (DLCO) >= 50% predicted
Pulmonary: Forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), and carbon monoxide diffusing capacity (DLCO) (corrected for Hb) greater than 50% predicted; for patients in which pulse oxymetry is performed, O2 saturation greater than 92%
Forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) > 60% predicted by pulmonary function test; for children who are unable to do pulmonary function tests (PFTs), no evidence of dyspnea at rest and no exercise intolerance should be documented; note: the pulmonary function test must be performed within 4 weeks prior to enrollment
Forced expiratory volume (FEV)1, forced vital capacity (FVC) and carbon monoxide diffusing capability (DLCO) (corrected for hemoglobin [Hgb]) >= 50%
Patients must have adequate pulmonary reserve evidenced by predicted post-operative forced expiratory volume in 1 second (FEV1) and diffusion capacity of the lung for carbon monoxide (DLCO) equal to or greater than 40% predicted; partial pressure of carbon dioxide measurement (pCO2) less than 50 mm Hg and partial pressure of oxygen measurement (pO2) greater than 60 mm Hg on room air arterial blood gas measurement (ABG); and be on no immunosuppressive medications except inhaled corticosteroids
Forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) >= 40% predicted, corrected diffusion capacity of the lung for carbon monoxide (DLCOc) >= 40% predicted
Forced expiratory volume in one second (FEV1) >= 40%; no symptomatic pulmonary disease
Forced vital capacity (FVC) >= 40%; no symptomatic pulmonary disease
Diffusing capacity of the lung for carbon monoxide (DLCO) >= 40%; no symptomatic pulmonary disease
Pulmonary function tests (PFTs) with diffusing capacity of the lung for carbon monoxide (DLCO) within 90 days prior to registration
Patient at high-risk of complications from lobectomy meeting a minimum of one major criteria or two minor criteria as described below:\r\n* Major criteria\r\n** Predicted postoperative forced expiratory volume in one second (FEV1) =< 40%\r\n** Predicted postoperative DLCO =< 40%\r\n** Age >= 72\r\n* Minor criteria\r\n** Predicted postoperative FEV1 41-60%\r\n** Predicted postoperative DLCO 41-60%\r\n** Pulmonary hypertension (defined by a pulmonary artery systolic pressure greater than 40 mm Hg) as estimated by echocardiography or right heart catheterization\r\n** Poor left ventricular function (defined as an ejection fraction 40% or less)\r\n** Resting or exercising arterial partial pressure of oxygen (pO2) =< 55 mmHg or oxygen saturation (SpO2) =< 88%\r\n** Partial pressure of carbon monoxide (pCO2) > 45 mm Hg\r\n** Modified Medical Research Council Dyspnea Scale >= 3
History of severe chronic obstructive pulmonary disease (COPD) defined as a forced expiratory volume in 1 second (FEV1) < 50% of predicted
Has a pre-treatment pulmonary function test (PFT) showing an carbon monoxide diffusing capability (DLCO) adjusted for hemoglobin of less than 60%
Adjusted diffusion capacity of the lung for carbon monoxide (DLCO) < 60%
Subjects with evidence of underlying obstructive pulmonary disease prior to transplant (clinical history of asthma or baseline forced expiratory volume in 1 second [FEV1] < 80% predicted with FEV1/forced vital capacity [FVC] < 80%)
Advanced pulmonary disease as assessed by clinical symptoms of shortness of breath or known forced expiratory volume in 1 second (FEV1) < 1
Forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) >= 40% of predicted; or if unable to perform pulmonary function tests due to young age, oxygen saturation > 92% on room air
Severe obstructive lung disease (forced expiratory volume in 1 second [FEV1]/forced vital capacity [FVC] < 70% post bronchodilator and forced expiratory volume in 1 second < 30% predicted)
FEV1 (forced expiratory volume in 1 second) >= 50% predicted
FVC (forced vital capacity) >= 50% predicted
DLCO (diffusing capacity of the lung for carbon monoxide) (corrected for hemoglobin) >= 50% of predicted
Pulmonary: asymptomatic or if symptomatic, diffusing capacity of the lung for carbon monoxide (DLCO) > 60% of predicted (corrected for hemoglobin)
Diffusing capacity for carbon monoxide (DLCO) adjusted for hemoglobin or forced vital capacity (FVC) > 50% predicted
Pulmonary disease with forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1) or diffusion capacity of the lung for carbon monoxide (DLCO) parameters < 45% predicted (corrected for hemoglobin) or requiring supplemental oxygen; children who are developmentally unable to perform pulmonary function testing will be assessed solely on their need for supplemental oxygen
Diffusing capacity of the lungs for carbon monoxide (DLCO) (corrected for hemoglobin), forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) >= 50% predicted
Forced expiratory volume in 1 second (FEV1) >= 50% or diffusion capacity of the lung for carbon monoxide (DLCO) (hemoglobin [Hb]) >= 40% of predicted, unless pulmonary dysfunction is deemed to be due to chronic GVHD
Forced vital capacity (FVC) or forced expiratory volume of the lung in 1 second (FEV1) >= 40% predicted
Diffusing capacity of the lung for carbon monoxide to alveolar volume (DLCO/VA) > 40%
A forced expiratory volume in one second (FEV1) of 60% or greater, a diffusion capacity of 50% or greater, and a oxygen partial pressure (PO2) of 80 mm mercury (Hg) or greater on pulmonary function testing
Forced expiratory volume in 1 second (FEV1) > 800 cc
Pulmonary function test including diffusing capacity of the lung for carbon monoxide (DLCO) will be performed; forced expiratory volume in 1 second (FEV1) and DLCO should be greater than 50% of predicted normal value
Corrected diffusing capacity of the lungs for carbon monoxide (DLCOcorr) > 40% normal
Pulmonary function: Diffusing capacity of the lung for carbon monoxide (DLCO) ? 50% (adjusted for hemoglobin), and forced expiratory volume in one second (FEV1) or forced vital capacity (FVC) ? 50%; for children who are unable to perform for Pulmonary Function Tests (PFTs) due to age or developmental ability, there must be no evidence of dyspnea and no need for supplemental oxygen, as evidenced by O2 saturation ? 92% on room air.
Chronic obstructive pulmonary disease (COPD), Global Initiative for Chronic Obstructive Lung Disease (GOLD) II or greater (defined as forced expiratory volume in 1 second [FEV1]/ forced vital capacity [FVC] < 70% and FEV1 % predicted < 80%)
Diffusing capacity of the lung for carbon monoxide (DLCO) > 40% predicted, corrected for hemoglobin and/or alveolar ventilation
Carbon monoxide diffusing capability test (DLCO) >= 50% (adjusted for hemoglobin) and forced expiratory volume in 1 second (FEV1) >= 50%
Forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), and adjusted diffusion capacity of the lung for carbon monoxide (DLCO) must be >= 50% of predicted values
Forced expiratory volume 1 (FEV1), forced vital capacity (FVC), and adjusted diffusing capacity of the lungs for carbon monoxide (DLCO) >= 50% of predicted values on pulmonary function tests
Diffusing capacity of the lungs for carbon monoxide (DLCO) >= 50% of predicted (corrected for hemoglobin)
Forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), and diffusion capacity of the lung for carbon monoxide (DLCO) adjusted >= 50% of predicted values on pulmonary function tests
Forced expiratory volume at one second (FEV1): best value obtained pre- or post-bronchodilator must be ? 1.0 liters/second or > 50% predicted value
Corrected diffusion capacity of the lung for carbon monoxide (DLCO) >= 50% by pulmonary function test
Forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), and diffusing capacity of the lung for carbon monoxide (DLCO) >= 50% of predicted values on pulmonary function tests
Corrected diffusion capacity of the lung for carbon monoxide (DLCO) < 40% of predicted, total lung capacity (TLC) < 30% of predicted, forced expiratory volume in one second (FEV1) < 30% of predicted, or receiving continuous supplementary oxygen
Diffusing capacity for carbon monoxide (hemoglobin corrected DLCO) < 50% predicted
Spirometry (FEV1 and forced vital capacity [FVC]) ?80% of predicted value
Diffusing capacity of the lungs for carbon monoxide (DLCO), forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) >= 40% predicted, and absence of oxygen (O2) requirements
Patients must have adequate pulmonary function: forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) at least 60% predicted value by spirometry
Diffusing capacity for carbon monoxide (DLCO) < 50% predicted
Forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) >= 50% predicted, corrected carbon monoxide diffusing capability test (DLCO) >= 40% predicted
Subjects with adequate physical function as measured by:a)Cardiac: Left ventricular ejection fraction at rest must be >35%, or shortening fraction > 25%. b)Hepatic: Bilirubin < 2.5 mg/dL; and ALT, AST, and Alkaline Phosphatase < 5 x ULN. c)Renal: Serum creatinine within normal range for age, or creatinine clearance or GFR > 40 mL/min/1.73m2. d)Pulmonary: FEV 1, FVC, DLCO (diffusion capacity) > 50% predicted (corrected for hemoglobin); or 02 saturation > 92% on room air.
Patients with poor lung function (forced expiratory volume in one second [FEV1]% < 50% or diffusion capacity of carbon monoxide [DLCO] < 50% predicted or home oxygen requirement) and lung lesions undergoing non-anatomic lung resection (i.e. wedge resection) OR
At least one of the following:\r\n* Mild or worse sputum cytologic atypia\r\n* Endobronchial dysplasia (score >= 4) on a previous bronchoscopy.\r\n* At least mild airflow limitation on pulmonary function testing (forced expiratory volume in one second [FEV1]/forced vital capacity [FVC] < 70% actual)
COPD, defined as forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) < 70% and FEV1% predicted < 80%
Pulmonary function: carbon monoxide diffusing capability test (DLCO) >= 40% (adjusted for hemoglobin) and forced expiratory volume in 1 second (FEV1) >= 50%
Pulmonary function: Diffusing capacity of the lung for carbon monoxide (DLCO) ? 40% (adjusted for hemoglobin) and forced expiratory volume in one second (FEV1) ? 50%
Subject has known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) < 50% predicted normal; Note that FEV1 testing is required for patients suspected of having COPD and subjects must be excluded if FEV1 < 50%
Patients receiving SBRT lung treatment and who have any one of the following high risk features:\r\n* Lung lesion > 5 cm\r\n* Diffusing capacity of the lungs for carbon monoxide (DLCO) < 35%\r\n* Forced expiratory volume, first second (FEV1) < 0.5 L\r\n* Central lung tumors (defined as within 2 cm from the proximal bronchial tree)\r\n* Tumors that abut the great vessels, trachea, spinal cord, or esophagus\r\n* Prior lobectomy or pneumonectomy\r\n* Prior lung radiation (SBRT or conventional definitive lung radiation)
Carbon monoxide diffusing capability (DLCO) > 60% (hemoglobin adjusted) by pulmonary function test (PFT)s