Refractory breast cancer
Item
patients with advanced stage refractory breast cancer
boolean
C0678222 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
progressive or relapsed disease following standard therapy
Item
progressive or relapsed disease following standard therapy
boolean
C0677932 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0277556 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
Measurable disease
Item
patients must have measurable disease that can include, but is not limited to bone; specifically, patients must have measurable extraskeletal disease that can be accurately measured in at least one dimension as >= 20 mm with conventional ct techniques or >= 10 mm with spiral ct scan; measurable (bi-dimensional) chest wall disease will also be allowed
boolean
C1513041 (UMLS CUI [1])
Cytotoxic chemotherapy
Item
patients must be at least 14 days out from last cytotoxic chemotherapy; patients on bisphosphonates are eligible
boolean
C0677881 (UMLS CUI [1])
White blood cell count
Item
white blood cell count (wbc) > 3.0 thou/ul
boolean
C0023508 (UMLS CUI [1])
Neutrophil count
Item
anc > 1.0 thou/ul
boolean
C0200633 (UMLS CUI [1])
Platelet count
Item
platelets >= 100 thou/ul
boolean
C0032181 (UMLS CUI [1])
Serum creatinine or creatinine clearance
Item
serum creatinine =< 2.0 mg/dl or creatinine clearance (calculated) >= 60 ml/min
boolean
C0201976 (UMLS CUI [1])
C2711451 (UMLS CUI [2])
ALT/AST
Item
alt/ast =< 2.0 x upper limit of normal
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
Total bilirubin
Item
total bilirubin =< 1.5 x upper limit of normal
boolean
C0201913 (UMLS CUI [1])
Albumin
Item
albumin >= 3.0 g/dl
boolean
C0201838 (UMLS CUI [1])
ECOG
Item
subjects must have a performance status score (ecog scale) =< 2
boolean
C1520224 (UMLS CUI [1])
Active concurrent medical illness precluding protocol treatment
Item
subjects must have recovered from major infections and/or surgical procedures and, in the opinion of the investigator, not have a significant active concurrent medical illness precluding protocol treatment
boolean
C0525058 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
Contraceptive methods
Item
men and women of reproductive ability must agree to contraceptive use during the study and for 1month after ontak treatment is discontinued
boolean
C0700589 (UMLS CUI [1])
Prior treatment with ontak (dab389 il-2) or dab486 il-2
Item
prior treatment with ontak (dab389 il-2) or dab486 il-2
boolean
C0722264 (UMLS CUI [1])
C0063713 (UMLS CUI [2])
Hypersensitivity to diphtheria toxin or il-2
Item
known history of hypersensitivity to diphtheria toxin or il-2
boolean
C0020517 (UMLS CUI [1,1])
C0012550 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0021756 (UMLS CUI [2,2])
Autoimmune disease
Item
active autoimmune disease
boolean
C0004364 (UMLS CUI [1])
Pulmonary disease
Item
known history of pulmonary disease except controlled asthma
boolean
C0024115 (UMLS CUI [1])
cardiovascular disease as defined by new york heart association class iii-iv categorization
Item
history of or pre-existing, cardiovascular disease as defined by new york heart association (nyha) class iii-iv categorization
boolean
C0007222 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Pregnant or breast-feeding
Item
pregnant or breast-feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])