ID

37736

Description

Vaccination of Patients With Breast Cancer With Dendritic Cell/Tumor Fusions and IL-12; ODM derived from: https://clinicaltrials.gov/show/NCT00622401

Link

https://clinicaltrials.gov/show/NCT00622401

Keywords

Versions (1)
  1. 8/20/19 8/20/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 20, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00622401

English

Eligibility Breast Cancer NCT00622401

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
stage iv breast cancer with measurable disease and accessible tumor
Description

Breast Carcinoma TNM Breast tumor staging | Measurable Disease | Tumor Access Possible

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0474926
UMLS CUI [2]
C1513041
UMLS CUI [3,1]
C0027651
UMLS CUI [3,2]
C0444454
UMLS CUI [3,3]
C0332149
ecog performance status 0-2 with greater than six week life expectancy
Description

ECOG performance status | Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0023671
18 years of age or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
laboratory values as outlined in the protocol
Description

Laboratory Results Consistent with Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C2348563
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients must not have received other immunotherapy treatment in the three months prior to the initial vaccination
Description

Immunotherapy Other

Data type

boolean

Alias
UMLS CUI [1,1]
C0021083
UMLS CUI [1,2]
C0205394
patients may not be on herceptin therapy during this protocol and may not have received it for four weeks prior to initial vaccination
Description

Herceptin

Data type

boolean

Alias
UMLS CUI [1]
C0338204
patients must not have received weekly chemotherapy or hormonal treatment for two weeks prior to the initial vaccination and must not have received monthly chemotherapy for four weeks prior to the initial vaccination
Description

Chemotherapy | Hormone Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0279025
clinical evidence of cns disease
Description

CNS disorder

Data type

boolean

Alias
UMLS CUI [1]
C0007682
clinically significant autoimmune disease
Description

Autoimmune Disease

Data type

boolean

Alias
UMLS CUI [1]
C0004364
patients who are hiv+
Description

HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0019699
serious intercurrent illness such as infection requiring iv antibiotics, or significant cardiac disease characterized by significant arrhythmia, ischemic coronary disease or congestive heart failure
Description

Comorbidity Serious | Communicable Disease Requirement Antibiotics Intravenous | Heart Disease | Cardiac Arrhythmia | Ischaemic coronary artery disorder | Congestive heart failure

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0003232
UMLS CUI [2,4]
C1522726
UMLS CUI [3]
C0018799
UMLS CUI [4]
C0003811
UMLS CUI [5]
C0852149
UMLS CUI [6]
C0018802
pregnant of lactating women will be excluded, all premenopausal women must undergo pregnancy testing
Description

Pregnancy | Breast Feeding | Premenopausal state Pregnancy Test

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0232969
UMLS CUI [3,2]
C0032976
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Similar models

Eligibility Breast Cancer NCT00622401

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma TNM Breast tumor staging | Measurable Disease | Tumor Access Possible
Item
stage iv breast cancer with measurable disease and accessible tumor
boolean
C0678222 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C1513041 (UMLS CUI [2])
C0027651 (UMLS CUI [3,1])
C0444454 (UMLS CUI [3,2])
C0332149 (UMLS CUI [3,3])
ECOG performance status | Life Expectancy
Item
ecog performance status 0-2 with greater than six week life expectancy
boolean
C1520224 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Age
Item
18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Laboratory Results Consistent with Study Protocol
Item
laboratory values as outlined in the protocol
boolean
C1254595 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Immunotherapy Other
Item
patients must not have received other immunotherapy treatment in the three months prior to the initial vaccination
boolean
C0021083 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Herceptin
Item
patients may not be on herceptin therapy during this protocol and may not have received it for four weeks prior to initial vaccination
boolean
C0338204 (UMLS CUI [1])
Chemotherapy | Hormone Therapy
Item
patients must not have received weekly chemotherapy or hormonal treatment for two weeks prior to the initial vaccination and must not have received monthly chemotherapy for four weeks prior to the initial vaccination
boolean
C0392920 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
CNS disorder
Item
clinical evidence of cns disease
boolean
C0007682 (UMLS CUI [1])
Autoimmune Disease
Item
clinically significant autoimmune disease
boolean
C0004364 (UMLS CUI [1])
HIV Seropositivity
Item
patients who are hiv+
boolean
C0019699 (UMLS CUI [1])
Comorbidity Serious | Communicable Disease Requirement Antibiotics Intravenous | Heart Disease | Cardiac Arrhythmia | Ischaemic coronary artery disorder | Congestive heart failure
Item
serious intercurrent illness such as infection requiring iv antibiotics, or significant cardiac disease characterized by significant arrhythmia, ischemic coronary disease or congestive heart failure
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0003232 (UMLS CUI [2,3])
C1522726 (UMLS CUI [2,4])
C0018799 (UMLS CUI [3])
C0003811 (UMLS CUI [4])
C0852149 (UMLS CUI [5])
C0018802 (UMLS CUI [6])
Pregnancy | Breast Feeding | Premenopausal state Pregnancy Test
Item
pregnant of lactating women will be excluded, all premenopausal women must undergo pregnancy testing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0232969 (UMLS CUI [3,1])
C0032976 (UMLS CUI [3,2])
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