ID

16912

Description

ONTAK® in Treating Patients With Advanced Breast Cancer That Did Not Respond to Previous Treatment; ODM derived from: https://clinicaltrials.gov/show/NCT00425672

Link

https://clinicaltrials.gov/show/NCT00425672

Keywords

Versions (1)
  1. 8/13/16 8/13/16 -
Uploaded on

August 13, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Male Breast Cancer NCT00425672

English

Eligibility Male Breast Cancer NCT00425672

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with advanced stage refractory breast cancer
Description

Refractory breast cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205269
progressive or relapsed disease following standard therapy
Description

progressive or relapsed disease following standard therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0677932
UMLS CUI [1,2]
C0087111
UMLS CUI [2,1]
C0277556
UMLS CUI [2,2]
C0087111
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
Description

Measurable disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
patients must be at least 14 days out from last cytotoxic chemotherapy; patients on bisphosphonates are eligible
Description

Cytotoxic chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0677881
white blood cell count (wbc) > 3.0 thou/ul
Description

White blood cell count

Data type

boolean

Alias
UMLS CUI [1]
C0023508
anc > 1.0 thou/ul
Description

Neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0200633
platelets >= 100 thou/ul
Description

Platelet count

Data type

boolean

Alias
UMLS CUI [1]
C0032181
serum creatinine =< 2.0 mg/dl or creatinine clearance (calculated) >= 60 ml/min
Description

Serum creatinine or creatinine clearance

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C2711451
alt/ast =< 2.0 x upper limit of normal
Description

ALT/AST

Data type

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
total bilirubin =< 1.5 x upper limit of normal
Description

Total bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C0201913
albumin >= 3.0 g/dl
Description

Albumin

Data type

boolean

Alias
UMLS CUI [1]
C0201838
subjects must have a performance status score (ecog scale) =< 2
Description

ECOG

Data type

boolean

Alias
UMLS CUI [1]
C1520224
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
Description

Active concurrent medical illness precluding protocol treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
men and women of reproductive ability must agree to contraceptive use during the study and for 1month after ontak treatment is discontinued
Description

Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior treatment with ontak (dab389 il-2) or dab486 il-2
Description

Prior treatment with ontak (dab389 il-2) or dab486 il-2

Data type

boolean

Alias
UMLS CUI [1]
C0722264
UMLS CUI [2]
C0063713
known history of hypersensitivity to diphtheria toxin or il-2
Description

Hypersensitivity to diphtheria toxin or il-2

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0012550
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0021756
active autoimmune disease
Description

Autoimmune disease

Data type

boolean

Alias
UMLS CUI [1]
C0004364
known history of pulmonary disease except controlled asthma
Description

Pulmonary disease

Data type

boolean

Alias
UMLS CUI [1]
C0024115
history of or pre-existing, cardiovascular disease as defined by new york heart association (nyha) class iii-iv categorization
Description

cardiovascular disease as defined by new york heart association class iii-iv categorization

Data type

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C1275491
pregnant or breast-feeding women
Description

Pregnant or breast-feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Male Breast Cancer NCT00425672

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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