Information:
Error:
ID
16450
Description
Administration of Autologous Dendritic Cells (DCs) Infected With an Adenovirus Expressing Her-2; ODM derived from: https://clinicaltrials.gov/show/NCT00197522
Link
https://clinicaltrials.gov/show/NCT00197522
Keywords
Versions (1)
- 7/17/16 7/17/16 -
Uploaded on
July 17, 2016
DOI
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License
Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT00197522
Eligibility Breast Neoplasms NCT00197522
- StudyEvent: Eligibility
Similar models
Eligibility Breast Neoplasms NCT00197522
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
her2/neu positive metastatic breast cancer
Item
patients with metastatic breast cancer who are her2/neu positive (3+ by immunohistochemistry or fish positive) and either
boolean
C0278488 (UMLS CUI [1,1])
C1960398 (UMLS CUI [1,2])
C1960398 (UMLS CUI [1,2])
hormonal therapy
Item
1. currently receiving hormonal therapy or are candidates for such or
boolean
C0279025 (UMLS CUI [1])
trastuzumab
Item
2. being considered for trastuzumab or
boolean
C0728747 (UMLS CUI [1])
cancer has progressed on trastuzumab
Item
3. their cancer has progressed on trastuzumab
boolean
C1947901 (UMLS CUI [1,1])
C0728747 (UMLS CUI [1,2])
C0728747 (UMLS CUI [1,2])
exclusion criteria
Item
patients are excluded from the study if they meet any one of the following criteria:
boolean
C0680251 (UMLS CUI [1])
age
Item
age less than 16 years.
boolean
C0001779 (UMLS CUI [1])
pregnant or lactating female
Item
pregnant or lactating female.
boolean
C0549206 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
C0006147 (UMLS CUI [1,2])
previous malignancy other than non-melanoma skin cancer.
Item
previous malignancy other than non-melanoma skin cancer.
boolean
C0006826 (UMLS CUI [1])
C3281209 (UMLS CUI [2])
C3281209 (UMLS CUI [2])
cytotoxic chemotherapy for metastatic disease
Item
more than three prior courses of cytotoxic chemotherapy for metastatic disease.
boolean
C0677881 (UMLS CUI [1])
C2939420 (UMLS CUI [2])
C2939420 (UMLS CUI [2])
combined modality therapy
Item
concurrent use of chemotherapy, immunotherapy, or gene therapy. concurrent hormonal therapy (tamoxifen, aromatase inhibitors or exemestane) is permitted.
boolean
C0009429 (UMLS CUI [1])
trastuzumab
Item
treatment with trastuzumab within 16 weeks prior to first dose of vaccine therapy.
boolean
C0728747 (UMLS CUI [1])
central nervous system metastases
Item
documented central nervous system metastases.
boolean
C0686377 (UMLS CUI [1])
acute illness that would interfere with the mobilization of stem cells or the administration of vaccination cellular therapy
Item
patients with any an acute illness that would interfere with the mobilization of stem cells or the administration of vaccination cellular therapy (ie. unstable angina, renal or liver failure, or severe chronic obstructive airways disease) are ineligible.
boolean
C4061114 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,2])
concurrent immunosuppressive therapy
Item
any patients requiring concurrent immunosuppressive therapy (eg. corticosteroids)
boolean
C0021079 (UMLS CUI [1,1])
C0205420 (UMLS CUI [1,2])
C0205420 (UMLS CUI [1,2])
life expectancy
Item
patients with a life expectancy of less than six months.
boolean
C0023671 (UMLS CUI [1])
ecog performance status
Item
ecog performance status of >2.
boolean
C1520224 (UMLS CUI [1])