ID

15608

Description

Vaccine Therapy With Sargramostim (GM-CSF) in Treating Patients With Her-2 Positive Stage III-IV Breast Cancer or Ovarian Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00436254

Link

https://clinicaltrials.gov/show/NCT00436254

Keywords

Versions (1)
  1. 6/4/16 6/4/16 -
Uploaded on

June 4, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility HER2-positive Breast Cancer NCT00436254

English

Eligibility HER2-positive Breast Cancer NCT00436254

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
breast cancer: stage iii or stage iv breast cancer with metastasis in remission and defined as ned (no evidence of disease); stable or healing bone disease by radiologic evaluation which may include, but is not limited to, bone scan, mri, or pet scan documented within 90 days of enrollment to study and ned status for extraskeletal metastasis
Description

breast cancer

Data type

boolean

Alias
UMLS CUI [1]
C0678222
ovarian cancer: stage iii or stage iv ovarian cancer in first complete remission with a normal and stable ca-125; thus, two sequential normal ca-125 values will need to be documented; a minimum of 30 days between 2 sequential ca-125 values; the most recent will be within 2 weeks of enrollment into study
Description

ovarian cancer

Data type

boolean

Alias
UMLS CUI [1]
C0029925
her2 overexpression by immunohistochemistry (ihc) of 2+ or 3+ in their primary tumor or metastasis, and if overexpression is 2+ by ihc or in the absence of ihc, then patients must have documentation of her2 gene amplification by fish
Description

her2 overexpression by immunohistochemistry

Data type

boolean

Alias
UMLS CUI [1]
C3810543
UMLS CUI [2]
C0021044
eligible subjects must have completed appropriate treatment for their primary disease and be off cytotoxic chemotherapy and corticosteroids for at least 1 month prior to enrollment; patients with stage iii/iv breast cancer who have completed chemotherapy and are continued on trastuzumab monotherapy are eligible; hormonal and bisphosphanate therapies are allowed
Description

therapeutic procedures

Data type

boolean

Alias
UMLS CUI [1]
C0087111
subjects must have a performance status score (zubrod/ecog scale) = 0
Description

performance status score

Data type

boolean

Alias
UMLS CUI [1]
C1518965
all subjects must no longer be able to bear children
Description

childbearing potential

Data type

boolean

Alias
UMLS CUI [1]
C3831118
hematocrit >= 30
Description

hematocrit

Data type

boolean

Alias
UMLS CUI [1]
C0518014
platelet count >= 100,000
Description

blood platelets

Data type

boolean

Alias
UMLS CUI [1]
C0005821
wbc >= 3,000/ul
Description

WBC

Data type

boolean

Alias
UMLS CUI [1]
C0023508
creatinine =< 2.0 or creatinine clearance >= 60 ml/minute
Description

creatinine

Data type

boolean

Alias
UMLS CUI [1]
C0010294
UMLS CUI [2]
C0373595
serum bilirubin < 1.5 mg/dl
Description

serum bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C1278039
sgot < 2 x uln
Description

SGOT (AST)

Data type

boolean

Alias
UMLS CUI [1]
C0201899
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 or survival
Description

major infections

Data type

boolean

Alias
UMLS CUI [1]
C0009450
normal ana, anti-dsdna and c3
Description

normal ana and anti-dsdna and c3

Data type

boolean

Alias
UMLS CUI [1]
C0003243
UMLS CUI [2]
C2746079
UMLS CUI [3]
C0009506
patients on trastuzumab monotherapy must have adequate cardiac function as demonstrated by normal ejection fraction (ef) of muga scan or echocardiogram
Description

trastuzumab monotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0728747
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects cannot be simultaneously enrolled on other treatment studies
Description

on other treatment studies

Data type

boolean

Alias
UMLS CUI [1]
C2348568
any contraindication to receiving gm-csf based vaccine products
Description

gm-csf based vaccine products

Data type

boolean

Alias
UMLS CUI [1,1]
C0079460
UMLS CUI [1,2]
C0042210
prior known history of cardiac disease, specifically restrictive cardiomyopathy, unstable angina within the last 6 months prior to enrollment, new york heart association functional class iii-iv heart or symptomatic pericardial effusion
Description

history of cardiac disease

Data type

boolean

Alias
UMLS CUI [1]
C0018799
prior known history of pulmonary disease other than controlled asthma
Description

pulmonary disease

Data type

boolean

Alias
UMLS CUI [1]
C0024115
active autoimmune disease
Description

active autoimmune disease

Data type

boolean

Alias
UMLS CUI [1]
C0004364
subjects cannot have active immunodeficiency disorder, e.g., hiv
Description

active immunodeficiency disorder

Data type

boolean

Alias
UMLS CUI [1]
C0021051
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Similar models

Eligibility HER2-positive Breast Cancer NCT00436254

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
breast cancer
Item
breast cancer: stage iii or stage iv breast cancer with metastasis in remission and defined as ned (no evidence of disease); stable or healing bone disease by radiologic evaluation which may include, but is not limited to, bone scan, mri, or pet scan documented within 90 days of enrollment to study and ned status for extraskeletal metastasis
boolean
C0678222 (UMLS CUI [1])
ovarian cancer
Item
ovarian cancer: stage iii or stage iv ovarian cancer in first complete remission with a normal and stable ca-125; thus, two sequential normal ca-125 values will need to be documented; a minimum of 30 days between 2 sequential ca-125 values; the most recent will be within 2 weeks of enrollment into study
boolean
C0029925 (UMLS CUI [1])
her2 overexpression by immunohistochemistry
Item
her2 overexpression by immunohistochemistry (ihc) of 2+ or 3+ in their primary tumor or metastasis, and if overexpression is 2+ by ihc or in the absence of ihc, then patients must have documentation of her2 gene amplification by fish
boolean
C3810543 (UMLS CUI [1])
C0021044 (UMLS CUI [2])
therapeutic procedures
Item
eligible subjects must have completed appropriate treatment for their primary disease and be off cytotoxic chemotherapy and corticosteroids for at least 1 month prior to enrollment; patients with stage iii/iv breast cancer who have completed chemotherapy and are continued on trastuzumab monotherapy are eligible; hormonal and bisphosphanate therapies are allowed
boolean
C0087111 (UMLS CUI [1])
performance status score
Item
subjects must have a performance status score (zubrod/ecog scale) = 0
boolean
C1518965 (UMLS CUI [1])
childbearing potential
Item
all subjects must no longer be able to bear children
boolean
C3831118 (UMLS CUI [1])
hematocrit
Item
hematocrit >= 30
boolean
C0518014 (UMLS CUI [1])
blood platelets
Item
platelet count >= 100,000
boolean
C0005821 (UMLS CUI [1])
WBC
Item
wbc >= 3,000/ul
boolean
C0023508 (UMLS CUI [1])
creatinine
Item
creatinine =< 2.0 or creatinine clearance >= 60 ml/minute
boolean
C0010294 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
serum bilirubin
Item
serum bilirubin < 1.5 mg/dl
boolean
C1278039 (UMLS CUI [1])
SGOT (AST)
Item
sgot < 2 x uln
boolean
C0201899 (UMLS CUI [1])
major infections
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 or survival
boolean
C0009450 (UMLS CUI [1])
normal ana and anti-dsdna and c3
Item
normal ana, anti-dsdna and c3
boolean
C0003243 (UMLS CUI [1])
C2746079 (UMLS CUI [2])
C0009506 (UMLS CUI [3])
trastuzumab monotherapy
Item
patients on trastuzumab monotherapy must have adequate cardiac function as demonstrated by normal ejection fraction (ef) of muga scan or echocardiogram
boolean
C0728747 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
on other treatment studies
Item
subjects cannot be simultaneously enrolled on other treatment studies
boolean
C2348568 (UMLS CUI [1])
gm-csf based vaccine products
Item
any contraindication to receiving gm-csf based vaccine products
boolean
C0079460 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
history of cardiac disease
Item
prior known history of cardiac disease, specifically restrictive cardiomyopathy, unstable angina within the last 6 months prior to enrollment, new york heart association functional class iii-iv heart or symptomatic pericardial effusion
boolean
C0018799 (UMLS CUI [1])
pulmonary disease
Item
prior known history of pulmonary disease other than controlled asthma
boolean
C0024115 (UMLS CUI [1])
active autoimmune disease
Item
active autoimmune disease
boolean
C0004364 (UMLS CUI [1])
active immunodeficiency disorder
Item
subjects cannot have active immunodeficiency disorder, e.g., hiv
boolean
C0021051 (UMLS CUI [1])
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