ID

22044

Description

Study of Safety and Tolerability of Intravenous CRS-100 in Adults With Carcinoma and Liver Metastases; ODM derived from: https://clinicaltrials.gov/show/NCT00327652

Link

https://clinicaltrials.gov/show/NCT00327652

Keywords

Versions (3)
  1. 5/16/17 5/16/17 -
  2. 5/16/17 5/16/17 -
  3. 9/20/21 9/20/21 -
Uploaded on

May 16, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Neoplasm Metastasis NCT00327652

English

Eligibility Neoplasm Metastasis NCT00327652

1 forms  
Criteria
Description

Criteria

1. documented carcinoma refractory to standard treatment (or for whom no standard treatment is available). hepatocellular carcinoma (hcc) is not allowed.
Description

Carcinoma | Standard therapy refractory | Standard therapy Unavailable | Liver carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0007097
UMLS CUI [2,1]
C2936643
UMLS CUI [2,2]
C0205269
UMLS CUI [3,1]
C2936643
UMLS CUI [3,2]
C0686905
UMLS CUI [4]
C2239176
2. hepatic metastases
Description

Secondary malignant neoplasm of liver

Data type

boolean

Alias
UMLS CUI [1]
C0494165
3. ecog performance status of 0 or 1, or karnofsky performance status (kps) of 80% to 100%.
Description

ECOG performance status | Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0206065
4. adequate organ function as defined by clinical hematology and chemistry assays.
Description

Organ function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
exclusion criteria (abbreviated):
Description

Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
1. known central nervous system metastases.
Description

CNS metastases

Data type

boolean

Alias
UMLS CUI [1]
C0686377
2. history of allergic reactions attributed to sulfa or beta-lactam antibiotics.
Description

Allergy to sulfonamides | BETA LACTAM ALLERGY

Data type

boolean

Alias
UMLS CUI [1]
C0038757
UMLS CUI [2]
C0741476
3. cardiac conditions associated with high- or moderate-risk of endocarditis.
Description

Condition cardiac | Endocarditis High risk | Endocarditis Risk Moderate

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0018787
UMLS CUI [2,1]
C0014118
UMLS CUI [2,2]
C0332167
UMLS CUI [3,1]
C0014118
UMLS CUI [3,2]
C0035647
UMLS CUI [3,3]
C0205081
4. intra-arterial hepatic catheter, hepatic cirrhosis, or clinically relevant ascites.
Description

Hepatic artery catheter | Liver Cirrhosis | Ascites

Data type

boolean

Alias
UMLS CUI [1]
C1321092
UMLS CUI [2]
C0023890
UMLS CUI [3]
C0003962
5. artificial (prosthetic) joint or other artificial implant or devices that cannot easily be removed.
Description

Artificial joint | Joint Prosthesis | Artificial Implants | Artificial structure

Data type

boolean

Alias
UMLS CUI [1]
C0481488
UMLS CUI [2]
C0022414
UMLS CUI [3]
C0021113
UMLS CUI [4]
C0336559
6. known coagulation disorder or recent thromboembolic event.
Description

Blood Coagulation Disorders | Thromboembolism

Data type

boolean

Alias
UMLS CUI [1]
C0005779
UMLS CUI [2]
C0040038
7. use of immunosuppressive agent, chemotherapy, or radiation therapy within 28 days prior to crs-100; bone marrow or stem cell transplant or a major organ allograft; autoimmune disease.
Description

Immunosuppressive Agents | Chemotherapy | Therapeutic radiology procedure | CRS-100 | Bone Marrow Transplantation | Stem cell transplant | Organ Major Allograft | Autoimmune Disease

Data type

boolean

Alias
UMLS CUI [1]
C0021081
UMLS CUI [2]
C0392920
UMLS CUI [3]
C1522449
UMLS CUI [4]
C1831855
UMLS CUI [5]
C0005961
UMLS CUI [6]
C1504389
UMLS CUI [7,1]
C0178784
UMLS CUI [7,2]
C0205164
UMLS CUI [7,3]
C0040739
UMLS CUI [8]
C0004364
8. current history of gallstones or kidney stones.
Description

Cholelithiasis | Nephrolithiasis

Data type

boolean

Alias
UMLS CUI [1]
C0008350
UMLS CUI [2]
C0392525
9. infection with hiv, human t-lymphotropic virus type 1 (htlv-1), hepatitis c virus (hcv), or hepatitis b virus (hbv).
Description

HIV Infection | Human T-cell lymphotropic virus 1 infection | Hepatitis C | Hepatitis B

Data type

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C1512326
UMLS CUI [3]
C0019196
UMLS CUI [4]
C0019163
10. pregnant or lactating
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Neoplasm Metastasis NCT00327652

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Carcinoma | Standard therapy refractory | Standard therapy Unavailable | Liver carcinoma
Item
1. documented carcinoma refractory to standard treatment (or for whom no standard treatment is available). hepatocellular carcinoma (hcc) is not allowed.
boolean
C0007097 (UMLS CUI [1])
C2936643 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
C2936643 (UMLS CUI [3,1])
C0686905 (UMLS CUI [3,2])
C2239176 (UMLS CUI [4])
Secondary malignant neoplasm of liver
Item
2. hepatic metastases
boolean
C0494165 (UMLS CUI [1])
ECOG performance status | Karnofsky Performance Status
Item
3. ecog performance status of 0 or 1, or karnofsky performance status (kps) of 80% to 100%.
boolean
C1520224 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
Organ function
Item
4. adequate organ function as defined by clinical hematology and chemistry assays.
boolean
C0678852 (UMLS CUI [1])
Exclusion Criteria
Item
exclusion criteria (abbreviated):
boolean
C0680251 (UMLS CUI [1])
CNS metastases
Item
1. known central nervous system metastases.
boolean
C0686377 (UMLS CUI [1])
Allergy to sulfonamides | BETA LACTAM ALLERGY
Item
2. history of allergic reactions attributed to sulfa or beta-lactam antibiotics.
boolean
C0038757 (UMLS CUI [1])
C0741476 (UMLS CUI [2])
Condition cardiac | Endocarditis High risk | Endocarditis Risk Moderate
Item
3. cardiac conditions associated with high- or moderate-risk of endocarditis.
boolean
C0348080 (UMLS CUI [1,1])
C0018787 (UMLS CUI [1,2])
C0014118 (UMLS CUI [2,1])
C0332167 (UMLS CUI [2,2])
C0014118 (UMLS CUI [3,1])
C0035647 (UMLS CUI [3,2])
C0205081 (UMLS CUI [3,3])
Hepatic artery catheter | Liver Cirrhosis | Ascites
Item
4. intra-arterial hepatic catheter, hepatic cirrhosis, or clinically relevant ascites.
boolean
C1321092 (UMLS CUI [1])
C0023890 (UMLS CUI [2])
C0003962 (UMLS CUI [3])
Artificial joint | Joint Prosthesis | Artificial Implants | Artificial structure
Item
5. artificial (prosthetic) joint or other artificial implant or devices that cannot easily be removed.
boolean
C0481488 (UMLS CUI [1])
C0022414 (UMLS CUI [2])
C0021113 (UMLS CUI [3])
C0336559 (UMLS CUI [4])
Blood Coagulation Disorders | Thromboembolism
Item
6. known coagulation disorder or recent thromboembolic event.
boolean
C0005779 (UMLS CUI [1])
C0040038 (UMLS CUI [2])
Immunosuppressive Agents | Chemotherapy | Therapeutic radiology procedure | CRS-100 | Bone Marrow Transplantation | Stem cell transplant | Organ Major Allograft | Autoimmune Disease
Item
7. use of immunosuppressive agent, chemotherapy, or radiation therapy within 28 days prior to crs-100; bone marrow or stem cell transplant or a major organ allograft; autoimmune disease.
boolean
C0021081 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C1831855 (UMLS CUI [4])
C0005961 (UMLS CUI [5])
C1504389 (UMLS CUI [6])
C0178784 (UMLS CUI [7,1])
C0205164 (UMLS CUI [7,2])
C0040739 (UMLS CUI [7,3])
C0004364 (UMLS CUI [8])
Cholelithiasis | Nephrolithiasis
Item
8. current history of gallstones or kidney stones.
boolean
C0008350 (UMLS CUI [1])
C0392525 (UMLS CUI [2])
HIV Infection | Human T-cell lymphotropic virus 1 infection | Hepatitis C | Hepatitis B
Item
9. infection with hiv, human t-lymphotropic virus type 1 (htlv-1), hepatitis c virus (hcv), or hepatitis b virus (hbv).
boolean
C0019693 (UMLS CUI [1])
C1512326 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
C0019163 (UMLS CUI [4])
Pregnancy | Breast Feeding
Item
10. pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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