ID

23496

Description

Safety and Efficacy Study Using Rexin-G for Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00505271

Link

https://clinicaltrials.gov/show/NCT00505271

Keywords

Versions (2)
  1. 7/8/17 7/8/17 -
  2. 9/20/21 9/20/21 -
Uploaded on

July 8, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00505271

English

Eligibility Breast Cancer NCT00505271

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically or cytologically confirmed recurrent or metastatic breast cancer that is refractory to standard chemotherapy and that is measurable.
Description

Breast cancer recurrent Chemotherapy refractory | Secondary malignant neoplasm of female breast Chemotherapy refractory | Breast cancer recurrent Measurable | Secondary malignant neoplasm of female breast Measurable

Data type

boolean

Alias
UMLS CUI [1,1]
C0278493
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0205269
UMLS CUI [2,1]
C0346993
UMLS CUI [2,2]
C0392920
UMLS CUI [2,3]
C0205269
UMLS CUI [3,1]
C0278493
UMLS CUI [3,2]
C1513040
UMLS CUI [4,1]
C0346993
UMLS CUI [4,2]
C1513040
2. adequate hepatic function: total bilirubin < 2.0 mg/dl (upper limit included); ast/alt < 2x institutional norm; alkaline phosphatase < 2.5x upper limit of institutional norm unless the patient has extensive bone metastases. patients with elevated alkaline phosphatase due to extensive liver disease will be excluded from study; albumin > 3.0 mg/dl. there must be no substantial ascites. pt and ptt must be within normal limits.
Description

Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Secondary malignant neoplasm of bone Extensive | Alkaline phosphatase raised Due to Liver disease Extensive | Albumin measurement | Ascites Absent | Prothrombin time normal | Activated partial thromboplastin time normal

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0201850
UMLS CUI [6,1]
C0153690
UMLS CUI [6,2]
C0205231
UMLS CUI [7,1]
C0151849
UMLS CUI [7,2]
C0678226
UMLS CUI [7,3]
C0023895
UMLS CUI [7,4]
C0205231
UMLS CUI [8]
C0201838
UMLS CUI [9,1]
C0003962
UMLS CUI [9,2]
C0332197
UMLS CUI [10]
C0580551
UMLS CUI [11]
C0853632
3. performance status must be < 1 (ecog 0-1) with a life expectancy of at least 3 months.
Description

ECOG performance status | Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0023671
4. hemoglobin > 9 gms%
Description

Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0518015
5. absolute granulocyte count > 1000/ul, and platelet count > 100,000/ul.
Description

Absolute neutrophil count | Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
6. serum creatinine of less than 1.5 mg%.
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
7. there must be no plans for the patient to receive further cancer therapy from the date of enrollment until the completion of the 6-week follow-up visit.
Description

Cancer treatment Plan Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C1301732
UMLS CUI [1,3]
C0332197
8. accessibility of peripheral or central iv line
Description

Accessibility Line Peripheral | Accessibility Line Intravenous central

Data type

boolean

Alias
UMLS CUI [1,1]
C0814423
UMLS CUI [1,2]
C0700221
UMLS CUI [1,3]
C0205100
UMLS CUI [2,1]
C0814423
UMLS CUI [2,2]
C0700221
UMLS CUI [2,3]
C0595846
9. age > 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
10. patients will be off chemotherapy for a minimum of 4 weeks prior to initiation of therapy and should have recovered to grade 1 or less toxicity.
Description

Chemotherapy Discontinued | Toxicity CTCAE Grades Patient recovered

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1444662
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C1516728
UMLS CUI [2,3]
C1115804
11. the ability to understand and the willingness to sign a written informed consent document.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. prior malignancy, except for non-melanoma skin cancer, stage 1 breast cancer, cis of cervix from which the patient has been disease-free for 5 years.
Description

Malignant Neoplasms | Skin carcinoma | Breast Carcinoma TNM Breast tumor staging | Carcinoma in situ of uterine cervix | Disease Free of

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0699893
UMLS CUI [3,1]
C0678222
UMLS CUI [3,2]
C0474926
UMLS CUI [4]
C0851140
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C0332296
2. woman who are pregnant or nursing
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
3. fertile patients unless they agree to use barrier contraception (condoms and spermicide jelly) during the vector infusion period and for six weeks after infusion. male patients must agree to use barrier contraception.
Description

Gender Barrier Contraception | Female Condoms | Vaginal Spermicides

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0004764
UMLS CUI [2]
C0221829
UMLS CUI [3]
C0087145
4. patients who are transfusion dependent (more than one transfusion per month)
Description

Blood transfusion dependent | Blood Transfusion Quantity per month

Data type

boolean

Alias
UMLS CUI [1]
C1698624
UMLS CUI [2,1]
C0005841
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0439507
5. patients with medical, psychiatric, or social conditions that would compromise successful adherence to this protocol.
Description

Medical condition compromises Protocol Compliance | Mental disorders compromise Protocol Compliance | Social Conditions compromise Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C0525058
UMLS CUI [3,1]
C0037403
UMLS CUI [3,2]
C2945640
UMLS CUI [3,3]
C0525058
6. patient who do not meet the inclusion criteria.
Description

Inclusion criteria Mismatch

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1881865
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Similar models

Eligibility Breast Cancer NCT00505271

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Breast cancer recurrent Chemotherapy refractory | Secondary malignant neoplasm of female breast Chemotherapy refractory | Breast cancer recurrent Measurable | Secondary malignant neoplasm of female breast Measurable
Item
1. histologically or cytologically confirmed recurrent or metastatic breast cancer that is refractory to standard chemotherapy and that is measurable.
boolean
C0278493 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0205269 (UMLS CUI [1,3])
C0346993 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C0205269 (UMLS CUI [2,3])
C0278493 (UMLS CUI [3,1])
C1513040 (UMLS CUI [3,2])
C0346993 (UMLS CUI [4,1])
C1513040 (UMLS CUI [4,2])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Secondary malignant neoplasm of bone Extensive | Alkaline phosphatase raised Due to Liver disease Extensive | Albumin measurement | Ascites Absent | Prothrombin time normal | Activated partial thromboplastin time normal
Item
2. adequate hepatic function: total bilirubin < 2.0 mg/dl (upper limit included); ast/alt < 2x institutional norm; alkaline phosphatase < 2.5x upper limit of institutional norm unless the patient has extensive bone metastases. patients with elevated alkaline phosphatase due to extensive liver disease will be excluded from study; albumin > 3.0 mg/dl. there must be no substantial ascites. pt and ptt must be within normal limits.
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0201850 (UMLS CUI [5])
C0153690 (UMLS CUI [6,1])
C0205231 (UMLS CUI [6,2])
C0151849 (UMLS CUI [7,1])
C0678226 (UMLS CUI [7,2])
C0023895 (UMLS CUI [7,3])
C0205231 (UMLS CUI [7,4])
C0201838 (UMLS CUI [8])
C0003962 (UMLS CUI [9,1])
C0332197 (UMLS CUI [9,2])
C0580551 (UMLS CUI [10])
C0853632 (UMLS CUI [11])
ECOG performance status | Life Expectancy
Item
3. performance status must be < 1 (ecog 0-1) with a life expectancy of at least 3 months.
boolean
C1520224 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Hemoglobin measurement
Item
4. hemoglobin > 9 gms%
boolean
C0518015 (UMLS CUI [1])
Absolute neutrophil count | Platelet Count measurement
Item
5. absolute granulocyte count > 1000/ul, and platelet count > 100,000/ul.
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
Creatinine measurement, serum
Item
6. serum creatinine of less than 1.5 mg%.
boolean
C0201976 (UMLS CUI [1])
Cancer treatment Plan Absent
Item
7. there must be no plans for the patient to receive further cancer therapy from the date of enrollment until the completion of the 6-week follow-up visit.
boolean
C0920425 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Accessibility Line Peripheral | Accessibility Line Intravenous central
Item
8. accessibility of peripheral or central iv line
boolean
C0814423 (UMLS CUI [1,1])
C0700221 (UMLS CUI [1,2])
C0205100 (UMLS CUI [1,3])
C0814423 (UMLS CUI [2,1])
C0700221 (UMLS CUI [2,2])
C0595846 (UMLS CUI [2,3])
Age
Item
9. age > 18 years
boolean
C0001779 (UMLS CUI [1])
Chemotherapy Discontinued | Toxicity CTCAE Grades Patient recovered
Item
10. patients will be off chemotherapy for a minimum of 4 weeks prior to initiation of therapy and should have recovered to grade 1 or less toxicity.
boolean
C0392920 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0600688 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
C1115804 (UMLS CUI [2,3])
Informed Consent
Item
11. the ability to understand and the willingness to sign a written informed consent document.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasms | Skin carcinoma | Breast Carcinoma TNM Breast tumor staging | Carcinoma in situ of uterine cervix | Disease Free of
Item
1. prior malignancy, except for non-melanoma skin cancer, stage 1 breast cancer, cis of cervix from which the patient has been disease-free for 5 years.
boolean
C0006826 (UMLS CUI [1])
C0699893 (UMLS CUI [2])
C0678222 (UMLS CUI [3,1])
C0474926 (UMLS CUI [3,2])
C0851140 (UMLS CUI [4])
C0012634 (UMLS CUI [5,1])
C0332296 (UMLS CUI [5,2])
Pregnancy | Breast Feeding
Item
2. woman who are pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Gender Barrier Contraception | Female Condoms | Vaginal Spermicides
Item
3. fertile patients unless they agree to use barrier contraception (condoms and spermicide jelly) during the vector infusion period and for six weeks after infusion. male patients must agree to use barrier contraception.
boolean
C0079399 (UMLS CUI [1,1])
C0004764 (UMLS CUI [1,2])
C0221829 (UMLS CUI [2])
C0087145 (UMLS CUI [3])
Blood transfusion dependent | Blood Transfusion Quantity per month
Item
4. patients who are transfusion dependent (more than one transfusion per month)
boolean
C1698624 (UMLS CUI [1])
C0005841 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0439507 (UMLS CUI [2,3])
Medical condition compromises Protocol Compliance | Mental disorders compromise Protocol Compliance | Social Conditions compromise Protocol Compliance
Item
5. patients with medical, psychiatric, or social conditions that would compromise successful adherence to this protocol.
boolean
C3843040 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0037403 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
Inclusion criteria Mismatch
Item
6. patient who do not meet the inclusion criteria.
boolean
C1512693 (UMLS CUI [1,1])
C1881865 (UMLS CUI [1,2])
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