[c09aa8]: / clusters / clusters342final / clust_167.txt

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Severe, active co-morbidity, defined as follows:* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months* Transmural myocardial infarction within the last 6 months* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of study entry* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of study entry * Coagulation defects; note, however, that coagulation parameters are not required for entry into this protocol
Severe, active co-morbidity, defined as follows:* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months* Transmural myocardial infarction within the last 6 months* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration* Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol* Acquired immune deficiency syndrome (AIDS) based upon the current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol; protocol-specific requirements may also exclude immuno-compromised patients
Severe, active co-morbidity, defined as follows per time points indicated below (or per time points indicated below prior to the first day of chemotherapy for patients having started chemotherapy prior to first step registration): * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months* Transmural myocardial infarction within the 3 months of study registration* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
Severe, active co-morbidity, defined as follows:* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months* Transmural myocardial infarction within the last 6 months* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration* Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects or severe liver dysfunction* Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol; protocol-specific requirements may also exclude immuno-compromised patients
Severe, active co-morbidity, defined as follows:* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months* Transmural myocardial infarction within the last 6 months* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of study entry* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of study entry* Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; hepatic or biliary disease that is acute or currently active or that requires antiviral therapy (with the exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease per investigator assessment)* History of left ventricular ejection fraction (LVEF) below institutional normal unless repeated and within institutional normal range within 90 days of study entry
Severe, active co-morbidity, defined as follows:* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months PRIOR TO registration* Transmural myocardial infarction within the last 6 months prior to study entry* Unstable ventricular arrhythmia within the last 6 months prior to study entry* Acute bacterial or fungal infection requiring intravenous antibiotics within 28 days prior to study entry* Hepatic insufficiency resulting in clinical jaundice, encephalopathy and/or variceal bleed within 28 days prior to study entry* Bleeding within 28 days prior to study entry due to any cause, requiring transfusion* Thrombolytic therapy within 28 days prior to study entry; subcutaneous heparin is permitted* Known bleeding or clotting disorder* Uncontrolled psychotic disorder
Severe, active co-morbidity, defined as follows:* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months* Transmural myocardial infarction within the last 6 months* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration* Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, coagulation parameters are not required for entry into this protocol* Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol* Pre-existing >= grade 2 neuropathy* Prior organ transplant
Severe, active co-morbidity, defined as follows:* Unstable angina and/or congestive heart failure requiring hospitalization within 6 months prior to registration* Transmural myocardial infarction within 6 months prior to registration* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration* Idiopathic pulmonary fibrosis or other severe interstitial lung disease that requires oxygen therapy or is thought to require oxygen therapy within 1 year prior to registration* Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for coagulation parameters are not required for entry into this protocol* Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease and Control and Prevention (CDC) definition; note: human immunodeficiency virus (HIV) testing is not required for entry into this protocol; protocol-specific requirements may also exclude immuno-compromised patients
Severe, active co-morbidity, defined as follows:* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months* Transmural myocardial infarction within the last 6 months* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration; hepatic insufficiency resulting in clinical jaundice and/or coagulation defects* Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol; protocol-specific requirements may also exclude immuno-compromised patients
Severe, active co-morbidity, defined as follows:* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months;* Transmural myocardial infarction within the last 6 months;* Chronic obstructive pulmonary disease exacerbation or other respiratory illness other than the diagnosed lung cancer requiring hospitalization or precluding study therapy within 30 days before registration;* Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol
Severe, active co-morbidity, defined as follows:* Major medical or psychiatric illness, which in the investigators opinion would interfere with the completion of therapy and follow up or with full understanding of the risks and potential complications of the therapy* Unstable angina and/or uncontrolled congestive heart failure* Myocardial infarction within the last 6 months* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; note that patients switched from IV antibiotics and currently on oral antibiotics whose infection is assessed to be adequately treated or controlled are eligible* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration* Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol
Severe, active co-morbidity, defined as follows:* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to registration* Transmural myocardial infarction within the last 6 months prior to registration* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration* Severe hepatic disease, defined as a diagnosis of Child-Pugh class B or C hepatic disease* Human immunodeficiency virus (HIV) positive with cluster of differentiation (CD) 4 count < 200 cells/microliter; note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to registration; note also that HIV testing is not required for eligibility for this protocol* End-stage renal disease (i.e., on dialysis or dialysis has been recommended)
Severe, active co-morbidity, defined as follows:* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months* Transmural myocardial infarction within the last 6 months* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration* Human immunodeficiency virus (HIV) positive with cluster of differentiation (CD)4 count < 200 cells/microliter; note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to registration; note also that HIV testing is not required for eligibility for this protocol* End-stage renal disease (i.e., on dialysis or dialysis has been recommended)
Severe, active co-morbidity, defined as follows:* Unstable angina at step 2 registration* Transmural myocardial infarction within the last 6 months prior to step 2 registration * Evidence of recent myocardial infarction or ischemia by the findings of S-T elevations of >= 2 mm using the analysis of an electrocardiogram (EKG) performed within 28 days prior to step 2 registration (Note: EKG to be performed only if clinical suspicion of cardiac issue)* New York Heart Association grade II or greater congestive heart failure requiring hospitalization within 12 months prior to step 2 registration* Serious and inadequately controlled arrhythmia at step 2 registration* Serious or non-healing wound, ulcer or bone fracture or history of abdominal fistula, intra-abdominal abscess requiring major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to step 2 registration, with the exception of the craniotomy for surgical resection * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of step 2 registration* Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for coagulation parameters are not required for entry into this protocol* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of step 2 registration* Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol* Any other severe immunocompromised condition* Active connective tissue disorders, such as lupus or scleroderma, that in the opinion of the treating physician may put the patient at high risk for radiation toxicity* End-stage renal disease (ie, on dialysis or dialysis has been recommended)* Any other major medical illnesses or psychiatric treatments that in the investigators opinion will prevent administration or completion of protocol therapy
Severe, active co-morbidity defined as follows:* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months* Transmural myocardial infarction within the last 6 months* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
Severe, active co-morbidity defined as follows:* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months* Transmural myocardial infarction within the last 6 months* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration* Chronic obstructive pulmonary disease exacerbation or other acute respiratory illness precluding study therapy at the time of registration* Severe hepatic disease defined as a diagnosis of Child-Pugh class B or C hepatic disease* Renal tubular acidosis or metabolic acidosis* Human immunodeficiency virus (HIV) positive with CD4 count < 200 cells/microliter; note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to registration; Note also that HIV testing is not required for eligibility for this protocol
Severe, active comorbidity, defined as follows:* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months* Transmural myocardial infarction within the last 6 months* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration* Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration* Uncontrolled, clinically significant cardiac arrhythmias* Human immunodeficiency virus (HIV) positive with cluster of differentiation (CD)4 count < 200 cells/microliter** Note: patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to Step 1 registration** Note: HIV testing is not required for eligibility for this protocol
Severe, active co-morbidity defined as follows:* Unstable angina and/or congestive heart failure requiring hospitalization within 6 months prior to registration* Transmural myocardial infarction within 6 months prior to registration* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; Note: if the infection resolves and the patient is on oral (p.o.) and still within, the required registration timeframe, then the patient is eligible* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration* Idiopathic pulmonary fibrosis or other severe interstitial lung disease that requires oxygen therapy or is thought to require oxygen therapy within 1 year prior to registration* History of (non-infectious) pneumonitis that required steroids or current pneumonitis* Acquired immune deficiency syndrome (AIDS) based upon current Center for Disease Control and Prevention (CDC) definition; note: human immunodeficiency virus (HIV) testing is not required for entry into this protocol; the need to exclude patients with AIDS from this protocol is necessary because the cisplatin and IMRT involved in this protocol may be significantly immunosuppressive; patients with known HIV, CD4 counts >= 250/uL, and undetectable viral loads who are stable on an antiretroviral regimen may be included* A diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of the MK-3475 (pembrolizumab)* Known history of active TB (Bacillus tuberculosis)* Known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis c virus [HCV] ribonucleic acid [RNA] [qualitative] is detected); Note: patients who have been curatively treated for hepatitis C and have no detectable viral load are eligible* Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs); replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
Severe and/or active co-morbidity defined as follows:* History of inflammatory bowel disease* History of active hepatitis B or C; blood tests are not required to determine if the patient has had hepatitis B or C, unless the patient reports a history of hepatitis* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months* Transmural myocardial infarction within the last 6 months* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of step 1 registration* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization within 15 days of step 1 registration or precluding study therapy at the time of step 1 registration* Uncontrolled severe illness or medical condition (including uncontrolled diabetes), which in the judgment of the treating physician would make the administration of chemotherapy inadvisable
Major medical illnesses or psychiatric impairments, which in the investigators opinion, will prevent administration or completion of the protocol therapy and/or preclude informed consent; these include, but are not restricted to:* Unstable angina and/or congestive heart failure requiring hospitalization at the time of step 2 registration* Transmural myocardial infarction within the last 6 months prior to step 2 registration* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of step 2 registration* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of step 2 registration* Type II neurofibromatosis (NF2)* Ailments entailing substantial increases in sensitivity and side effect risk from radiation therapy (ataxia telangiectasia, Nijmegen breakage syndrome, and human immunodeficiency virus (HIV) with CD4 count < 200 cells/microliter); HIV testing is not required for eligibility for this protocol, and known HIV positive patients are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to step 2 registration* Inability to undergo MRI with and without contrast (e.g. claustrophobia, non-MRI compatible implant or foreign body, etc) or receive gadolinium; note that patients with severe claustrophobia are permitted on this study if they are willing and able to undergo MRI with adequate sedation or anesthesia
Severe, active co-morbidity, defined as follows:* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months* Transmural myocardial infarction within the last 6 months* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of step 1 registration* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of step 1 registration* Severe hepatic disease, defined as a diagnosis of Child-Pugh class B or C hepatic disease* Human immunodeficiency virus (HIV) positive with cluster of differentiation (CD)4 count < 200 cells/microliter; note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to registration; note also that HIV testing is not required for eligibility for this protocol* End-stage renal disease (ie, on dialysis or dialysis has been recommended)
Severe, active co-morbidity defined as follows:* Unstable angina or congestive heart failure requiring hospitalization within 6 months prior to enrollment* Transmural myocardial infarction within the last 6 months prior to registration; evidence of recent myocardial infarction or ischemia by the findings of S-T elevations of >= 2 mm using the analysis of an electrocardiogram (EKG) performed within 28 days prior to registration (Note: EKG to be performed only if clinical suspicion of cardiac issue)* New York Heart Association grade II or greater congestive heart failure requiring hospitalization within 12 months prior to registration* Serious and inadequately controlled arrhythmia at step 2 registration* Serious or non-healing wound, ulcer or bone fracture or history of abdominal fistula, intra-abdominal abscess requiring major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to registration, with the exception of the craniotomy for surgical resection* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration* Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for coagulation parameters are not required for entry into this protocol* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration* Human immunodeficiency virus (HIV) positive with CD4 count < 200 cells/microliter; acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that HIV testing is not required for entry into this protocol* Any other severe immunocompromised condition* Active connective tissue disorders, such as lupus or scleroderma, that in the opinion of the treating physician may put the patient at high risk for radiation toxicity* End-stage renal disease (i.e., on dialysis or dialysis has been recommended)* Any other major medical illnesses or psychiatric treatments that in the investigators opinion will prevent administration or completion of protocol therapy