ID

26760

Description

Autologous Vaccination With Lethally Irradiated, Autologous Breast Cancer Cells Engineered to Secrete GM-CSF in Women With Operable Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00880464

Link

https://clinicaltrials.gov/show/NCT00880464

Keywords

Versions (1)
  1. 10/24/17 10/24/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 24, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00880464

English

Eligibility Breast Cancer NCT00880464

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed invasive breast cancer, pre-operative stages ii-iii per ajcc 6th edition, based on baseline evaluation by clinical examination and/or breast imaging
Description

Invasive carcinoma of breast Preoperative TNM Breast tumor staging | Clinical examination | Imaging Breast

Data type

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0445204
UMLS CUI [1,3]
C0474926
UMLS CUI [2]
C1456356
UMLS CUI [3,1]
C0011923
UMLS CUI [3,2]
C0006141
cohort 1: at least 2cm of residual disease in sum of diameters by clinical or radiographic findings following their preoperative chemotherapy
Description

Residual Tumor Diameter Signs and Symptoms | Residual Tumor Diameter Radiography | Preoperative Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0543478
UMLS CUI [1,2]
C1301886
UMLS CUI [1,3]
C0037088
UMLS CUI [2,1]
C0543478
UMLS CUI [2,2]
C1301886
UMLS CUI [2,3]
C0034571
UMLS CUI [3]
C2347669
cohort 2: patients who have not received preoperative chemotherapy must have at least 4cm of disease in the largest diameter by clinical or radiographic findings
Description

Preoperative Chemotherapy Absent | Disease Diameter Largest Signs and Symptoms | Disease Diameter Largest Radiography

Data type

boolean

Alias
UMLS CUI [1,1]
C2347669
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C1301886
UMLS CUI [2,3]
C0443228
UMLS CUI [2,4]
C0037088
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C1301886
UMLS CUI [3,3]
C0443228
UMLS CUI [3,4]
C0034571
prior therapy for cohort 1 only: must have completed preoperative (neoadjuvant) chemotherapy with either a standard regimen (containing an anthracycline and/or a taxane) or on a clinical trial
Description

Preoperative Chemotherapy Neoadjuvant Completed | Anthracyclines | taxane

Data type

boolean

Alias
UMLS CUI [1,1]
C2347669
UMLS CUI [1,2]
C0600558
UMLS CUI [1,3]
C0205197
UMLS CUI [2]
C0282564
UMLS CUI [3]
C0215136
her2 positive tumors must have received at least one prior trastuzumab-based therapy, and may not receive concurrent trastuzumab therapy and vaccination
Description

Neoplasms HER2/Neu Positive | Prior Therapy Quantity Trastuzumab | Trastuzumab Absent | Vaccination Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C2348909
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0728747
UMLS CUI [3,1]
C0728747
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0042196
UMLS CUI [4,2]
C0332197
must initiate hormonal therapy (if indicated), including ovarian suppression, at least 4 weeks prior to initiation of vaccinations
Description

Hormone Therapy | Indication Hormone Therapy | Ovarian suppression | Vaccination

Data type

boolean

Alias
UMLS CUI [1]
C0279025
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0279025
UMLS CUI [3]
C0677922
UMLS CUI [4]
C0042196
must have completed definitive resection of primary tumor with adequated excision of gross disease. surgery should have occured more than 28 days but within 12 weeks prior to enrollment
Description

Primary tumor Excision Definitive Completed | Disease Gross Excision

Data type

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0728940
UMLS CUI [1,3]
C0443196
UMLS CUI [1,4]
C0205197
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0439806
UMLS CUI [2,3]
C0728940
may receive concurrent hormonal therapy, such as tamoxifen, ovarian suppression, and aromatase inhibitors
Description

Hormone Therapy | Tamoxifen | Ovarian suppression | Aromatase Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0279025
UMLS CUI [2]
C0039286
UMLS CUI [3]
C0677922
UMLS CUI [4]
C0593802
must have had prior banked tumor of sufficient cellular yield for vaccination
Description

Neoplastic Cell Vaccination

Data type

boolean

Alias
UMLS CUI [1,1]
C0597032
UMLS CUI [1,2]
C0042196
ecog performance status 0 or 1
Description

ECOG performance status

Data type

boolean

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

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
greater than 4 weeks from immunotherapy, or systemic glucocorticoid therapy
Description

Immunotherapy | Glucocorticoids, Systemic

Data type

boolean

Alias
UMLS CUI [1]
C0021083
UMLS CUI [2]
C3540777
adequate recovery from recent surgery and radiation therapy
Description

Operative Surgical Procedures Recent Patient recovered | Therapeutic radiology procedure Recent Patient recovered

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0332185
UMLS CUI [1,3]
C1115804
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0332185
UMLS CUI [2,3]
C1115804
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
uncontrolled active infection or illness
Description

Communicable Disease Uncontrolled | Illness Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0205318
other medical or psychiatric illness or social situation that would limit study compliance
Description

Illness Protocol Compliance Limited | Mental disorders Protocol Compliance Limited | Social situation Protocol Compliance Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0525058
UMLS CUI [1,3]
C0439801
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0525058
UMLS CUI [2,3]
C0439801
UMLS CUI [3,1]
C0748872
UMLS CUI [3,2]
C0525058
UMLS CUI [3,3]
C0439801
pregnancy or nursing mothers
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
evidence of hiv infection
Description

HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0019693
previous participation in an adenovirus-based trial
Description

Study Subject Participation Status | Clinical Trial Adenoviruses Based

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0001483
UMLS CUI [2,3]
C1705938
concurrent invasive malignancies
Description

Invasive cancer

Data type

boolean

Alias
UMLS CUI [1]
C0677898
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Similar models

Eligibility Breast Cancer NCT00880464

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast Preoperative TNM Breast tumor staging | Clinical examination | Imaging Breast
Item
histologically or cytologically confirmed invasive breast cancer, pre-operative stages ii-iii per ajcc 6th edition, based on baseline evaluation by clinical examination and/or breast imaging
boolean
C0853879 (UMLS CUI [1,1])
C0445204 (UMLS CUI [1,2])
C0474926 (UMLS CUI [1,3])
C1456356 (UMLS CUI [2])
C0011923 (UMLS CUI [3,1])
C0006141 (UMLS CUI [3,2])
Residual Tumor Diameter Signs and Symptoms | Residual Tumor Diameter Radiography | Preoperative Chemotherapy
Item
cohort 1: at least 2cm of residual disease in sum of diameters by clinical or radiographic findings following their preoperative chemotherapy
boolean
C0543478 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0037088 (UMLS CUI [1,3])
C0543478 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
C0034571 (UMLS CUI [2,3])
C2347669 (UMLS CUI [3])
Preoperative Chemotherapy Absent | Disease Diameter Largest Signs and Symptoms | Disease Diameter Largest Radiography
Item
cohort 2: patients who have not received preoperative chemotherapy must have at least 4cm of disease in the largest diameter by clinical or radiographic findings
boolean
C2347669 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
C0443228 (UMLS CUI [2,3])
C0037088 (UMLS CUI [2,4])
C0012634 (UMLS CUI [3,1])
C1301886 (UMLS CUI [3,2])
C0443228 (UMLS CUI [3,3])
C0034571 (UMLS CUI [3,4])
Preoperative Chemotherapy Neoadjuvant Completed | Anthracyclines | taxane
Item
prior therapy for cohort 1 only: must have completed preoperative (neoadjuvant) chemotherapy with either a standard regimen (containing an anthracycline and/or a taxane) or on a clinical trial
boolean
C2347669 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0282564 (UMLS CUI [2])
C0215136 (UMLS CUI [3])
Neoplasms HER2/Neu Positive | Prior Therapy Quantity Trastuzumab | Trastuzumab Absent | Vaccination Absent
Item
her2 positive tumors must have received at least one prior trastuzumab-based therapy, and may not receive concurrent trastuzumab therapy and vaccination
boolean
C0027651 (UMLS CUI [1,1])
C2348909 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0728747 (UMLS CUI [2,3])
C0728747 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0042196 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Hormone Therapy | Indication Hormone Therapy | Ovarian suppression | Vaccination
Item
must initiate hormonal therapy (if indicated), including ovarian suppression, at least 4 weeks prior to initiation of vaccinations
boolean
C0279025 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0279025 (UMLS CUI [2,2])
C0677922 (UMLS CUI [3])
C0042196 (UMLS CUI [4])
Primary tumor Excision Definitive Completed | Disease Gross Excision
Item
must have completed definitive resection of primary tumor with adequated excision of gross disease. surgery should have occured more than 28 days but within 12 weeks prior to enrollment
boolean
C0677930 (UMLS CUI [1,1])
C0728940 (UMLS CUI [1,2])
C0443196 (UMLS CUI [1,3])
C0205197 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C0439806 (UMLS CUI [2,2])
C0728940 (UMLS CUI [2,3])
Hormone Therapy | Tamoxifen | Ovarian suppression | Aromatase Inhibitors
Item
may receive concurrent hormonal therapy, such as tamoxifen, ovarian suppression, and aromatase inhibitors
boolean
C0279025 (UMLS CUI [1])
C0039286 (UMLS CUI [2])
C0677922 (UMLS CUI [3])
C0593802 (UMLS CUI [4])
Neoplastic Cell Vaccination
Item
must have had prior banked tumor of sufficient cellular yield for vaccination
boolean
C0597032 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
ECOG performance status
Item
ecog performance status 0 or 1
boolean
C1520224 (UMLS CUI [1])
Age
Item
18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Immunotherapy | Glucocorticoids, Systemic
Item
greater than 4 weeks from immunotherapy, or systemic glucocorticoid therapy
boolean
C0021083 (UMLS CUI [1])
C3540777 (UMLS CUI [2])
Operative Surgical Procedures Recent Patient recovered | Therapeutic radiology procedure Recent Patient recovered
Item
adequate recovery from recent surgery and radiation therapy
boolean
C0543467 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C1115804 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C1115804 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Communicable Disease Uncontrolled | Illness Uncontrolled
Item
uncontrolled active infection or illness
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0221423 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Illness Protocol Compliance Limited | Mental disorders Protocol Compliance Limited | Social situation Protocol Compliance Limited
Item
other medical or psychiatric illness or social situation that would limit study compliance
boolean
C0221423 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C0525058 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
C0748872 (UMLS CUI [3,1])
C0525058 (UMLS CUI [3,2])
C0439801 (UMLS CUI [3,3])
Pregnancy | Breast Feeding
Item
pregnancy or nursing mothers
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
HIV Infection
Item
evidence of hiv infection
boolean
C0019693 (UMLS CUI [1])
Study Subject Participation Status | Clinical Trial Adenoviruses Based
Item
previous participation in an adenovirus-based trial
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0001483 (UMLS CUI [2,2])
C1705938 (UMLS CUI [2,3])
Invasive cancer
Item
concurrent invasive malignancies
boolean
C0677898 (UMLS CUI [1])
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