ID

44617

Description

Immunization With AFP + GM CSF Plasmid Prime and AFP Adenoviral Vector Boost in Patients With Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00669136

Link

https://clinicaltrials.gov/show/NCT00669136

Keywords

Versions (2)
  1. 6/5/20 6/5/20 -
  2. 9/27/21 9/27/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 27, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT00669136

English

Eligibility Hepatocellular Carcinoma NCT00669136

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
eligible patients must have locoregionally treated hcc and have a prior afp serum determination over the limit of normality for each laboratory.
Description

Therapy Locoregional Liver carcinoma | Elevated alpha-fetoprotein

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1947913
UMLS CUI [1,3]
C2239176
UMLS CUI [2]
C0235971
this study will enroll adults over the age of 18.
Description

Adult | Age

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
have had hcc with a history of serum afp determination above the upper limit of normality for each laboratory.
Description

Liver carcinoma | Elevated alpha-fetoprotein

Data type

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2]
C0235971
both male and female patients may be enrolled. premenopausal females who have not undergone a surgical sterilization procedure must have a negative pregnancy test prior to treatment. sexually active females of child-bearing potential are required to use two forms of contraception, including a barrier method, for trial eligibility. sexually active males should use an appropriate "double barrier" method of birth control (such as female use of a diaphragm, intrauterine device (iud), or contraceptive sponge, in addition to male use of a condom.
Description

Gender | Premenopausal state Pregnancy test negative | Female Sterilization Absent | Childbearing Potential Sexually active Contraceptive methods Quantity | Contraception, Barrier | Gender Sexually active Barrier Contraception Double | Vaginal contraceptive diaphragm | Intrauterine Device | Contraceptive Sponge | Condoms, Male

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0232969
UMLS CUI [2,2]
C0427780
UMLS CUI [3,1]
C0015787
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0241028
UMLS CUI [4,3]
C0700589
UMLS CUI [4,4]
C1265611
UMLS CUI [5]
C0004764
UMLS CUI [6,1]
C0079399
UMLS CUI [6,2]
C0241028
UMLS CUI [6,3]
C0004764
UMLS CUI [6,4]
C0205173
UMLS CUI [7]
C0042241
UMLS CUI [8]
C0021900
UMLS CUI [9]
C0183461
UMLS CUI [10]
C0009653
be hla-a2.1 positive (hla-a*0201) by dna subtyping, or hla-a2 positive by flow cytometry with antibodies ma2.1 and bb7.2.
Description

HLA-A2 Positive DNA analysis | HLA-A2 Positive Flow Cytometry

Data type

boolean

Alias
UMLS CUI [1,1]
C2348915
UMLS CUI [1,2]
C0200898
UMLS CUI [2,1]
C2348915
UMLS CUI [2,2]
C0016263
stage ii to iva hcc after locoregional therapy (surgical resection, radio-frequency ablation, cryoablation, ethanol injection, chemoembolization and radioembolization).
Description

Liver carcinoma TNM clinical staging | Status post Therapy Locoregional | Excision | Radiofrequency ablation | Cryosurgery | Ethanol Injection | Chemoembolization | Radioembolisation

Data type

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C1947913
UMLS CUI [3]
C0728940
UMLS CUI [4]
C0850292
UMLS CUI [5]
C0010408
UMLS CUI [6]
C4307245
UMLS CUI [7]
C0796679
UMLS CUI [8]
C2985560
karnofsky performance status greater than or equal to 70 percent.
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
no evidence of opportunistic infection in the year before enrollment.
Description

Opportunistic Infection Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0029118
UMLS CUI [1,2]
C0332197
adequate baseline hematological function as assessed by the following laboratory values within 30 days prior to study entry (day -30 to 0):
Description

Hematologic function

Data type

boolean

Alias
UMLS CUI [1]
C0221130
hemoglobin > 9.0 g/dl (patients cannot be transfusion dependent) platelets > 50,000/mm3 absolute neutrophil count (anc) > 1,000/mm3
Description

Hemoglobin measurement | Absence Patients Blood transfusion dependent | Platelet Count measurement | Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0030705
UMLS CUI [2,3]
C1698624
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0948762
conserved liver function with a child-pugh class a or b.
Description

Liver function Child-Pugh Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C4050412
ability to give informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who meet any one of the following criteria will be excluded from study entry:
Description

Criteria Any Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1552551
UMLS CUI [1,3]
C1550543
any congenital or acquired condition leading to inability to generate an immune response, including concomitant immune suppressive therapy. the ability to adequately respond to recall skin test antigens will be tested before trial entry but a negative response to skin allergens will not be reason for exclusion.
Description

Congenital condition Immune response Unable | Condition Immune response Unable | Therapeutic immunosuppression

Data type

boolean

Alias
UMLS CUI [1,1]
C3649644
UMLS CUI [1,2]
C0020964
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0020964
UMLS CUI [2,3]
C1299582
UMLS CUI [3]
C0021079
concomitant steroid therapy or chemotherapy, or any of these treatments < 30 days before the first vaccination.
Description

Steroid therapy | Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0149783
UMLS CUI [2]
C0392920
females of child-bearing potential (premenopausal and not surgically sterilized) must have a negative serum hcg pregnancy test (within day 14 to day 0).
Description

Childbearing Potential Serum pregnancy test (B-HCG) Negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430060
UMLS CUI [1,3]
C1513916
acute infection: any acute viral, bacterial, or fungal infection, which requires specific therapy excluding hbv or hcv. acute therapy must have been completed within 14 days prior to study treatment.
Description

Communicable Disease | Virus Diseases | Bacterial Infections | Mycoses | Requirement Therapy Specific | Exception Hepatitis B | Exception Hepatitis C | Treatment completed

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0042769
UMLS CUI [3]
C0004623
UMLS CUI [4]
C0026946
UMLS CUI [5,1]
C1514873
UMLS CUI [5,2]
C0087111
UMLS CUI [5,3]
C0205369
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0019163
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0019196
UMLS CUI [8]
C0580352
hiv-infected patients (their ability to generate a cellular immune response is altered due to the cd4-dependent immunosuppressive effects of the hiv infection).
Description

HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0019693
patients with any underlying conditions which would contraindicate therapy with study treatment (or allergies to reagents used in this study).
Description

Primary disorders Investigational Therapy Contraindicated | Hypersensitivity Reagents

Data type

boolean

Alias
UMLS CUI [1,1]
C0277554
UMLS CUI [1,2]
C0949266
UMLS CUI [1,3]
C1444657
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0034760
patients with organ allografts (they require prolonged immunosuppressive therapy).
Description

Organ Allograft

Data type

boolean

Alias
UMLS CUI [1,1]
C0178784
UMLS CUI [1,2]
C0450127
patients with high serum titers of neutralizing anti-adenoviral antibodies (positive at greater than 1:128 dilution by serum adv blocking assay, expected to be approximately 30% of patients, they have a greatly reduced ability to respond to the adv boost).
Description

Serum complement titer increased Neutralizing Antibodies Adenoviral

Data type

boolean

Alias
UMLS CUI [1,1]
C0860571
UMLS CUI [1,2]
C0475463
UMLS CUI [1,3]
C0001483
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Similar models

Eligibility Hepatocellular Carcinoma NCT00669136

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Therapy Locoregional Liver carcinoma | Elevated alpha-fetoprotein
Item
eligible patients must have locoregionally treated hcc and have a prior afp serum determination over the limit of normality for each laboratory.
boolean
C0087111 (UMLS CUI [1,1])
C1947913 (UMLS CUI [1,2])
C2239176 (UMLS CUI [1,3])
C0235971 (UMLS CUI [2])
Adult | Age
Item
this study will enroll adults over the age of 18.
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Liver carcinoma | Elevated alpha-fetoprotein
Item
have had hcc with a history of serum afp determination above the upper limit of normality for each laboratory.
boolean
C2239176 (UMLS CUI [1])
C0235971 (UMLS CUI [2])
Gender | Premenopausal state Pregnancy test negative | Female Sterilization Absent | Childbearing Potential Sexually active Contraceptive methods Quantity | Contraception, Barrier | Gender Sexually active Barrier Contraception Double | Vaginal contraceptive diaphragm | Intrauterine Device | Contraceptive Sponge | Condoms, Male
Item
both male and female patients may be enrolled. premenopausal females who have not undergone a surgical sterilization procedure must have a negative pregnancy test prior to treatment. sexually active females of child-bearing potential are required to use two forms of contraception, including a barrier method, for trial eligibility. sexually active males should use an appropriate "double barrier" method of birth control (such as female use of a diaphragm, intrauterine device (iud), or contraceptive sponge, in addition to male use of a condom.
boolean
C0079399 (UMLS CUI [1])
C0232969 (UMLS CUI [2,1])
C0427780 (UMLS CUI [2,2])
C0015787 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0241028 (UMLS CUI [4,2])
C0700589 (UMLS CUI [4,3])
C1265611 (UMLS CUI [4,4])
C0004764 (UMLS CUI [5])
C0079399 (UMLS CUI [6,1])
C0241028 (UMLS CUI [6,2])
C0004764 (UMLS CUI [6,3])
C0205173 (UMLS CUI [6,4])
C0042241 (UMLS CUI [7])
C0021900 (UMLS CUI [8])
C0183461 (UMLS CUI [9])
C0009653 (UMLS CUI [10])
HLA-A2 Positive DNA analysis | HLA-A2 Positive Flow Cytometry
Item
be hla-a2.1 positive (hla-a*0201) by dna subtyping, or hla-a2 positive by flow cytometry with antibodies ma2.1 and bb7.2.
boolean
C2348915 (UMLS CUI [1,1])
C0200898 (UMLS CUI [1,2])
C2348915 (UMLS CUI [2,1])
C0016263 (UMLS CUI [2,2])
Liver carcinoma TNM clinical staging | Status post Therapy Locoregional | Excision | Radiofrequency ablation | Cryosurgery | Ethanol Injection | Chemoembolization | Radioembolisation
Item
stage ii to iva hcc after locoregional therapy (surgical resection, radio-frequency ablation, cryoablation, ethanol injection, chemoembolization and radioembolization).
boolean
C2239176 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C1947913 (UMLS CUI [2,3])
C0728940 (UMLS CUI [3])
C0850292 (UMLS CUI [4])
C0010408 (UMLS CUI [5])
C4307245 (UMLS CUI [6])
C0796679 (UMLS CUI [7])
C2985560 (UMLS CUI [8])
Karnofsky Performance Status
Item
karnofsky performance status greater than or equal to 70 percent.
boolean
C0206065 (UMLS CUI [1])
Opportunistic Infection Absent
Item
no evidence of opportunistic infection in the year before enrollment.
boolean
C0029118 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Hematologic function
Item
adequate baseline hematological function as assessed by the following laboratory values within 30 days prior to study entry (day -30 to 0):
boolean
C0221130 (UMLS CUI [1])
Hemoglobin measurement | Absence Patients Blood transfusion dependent | Platelet Count measurement | Absolute neutrophil count
Item
hemoglobin > 9.0 g/dl (patients cannot be transfusion dependent) platelets > 50,000/mm3 absolute neutrophil count (anc) > 1,000/mm3
boolean
C0518015 (UMLS CUI [1])
C0332197 (UMLS CUI [2,1])
C0030705 (UMLS CUI [2,2])
C1698624 (UMLS CUI [2,3])
C0032181 (UMLS CUI [3])
C0948762 (UMLS CUI [4])
Liver function Child-Pugh Classification
Item
conserved liver function with a child-pugh class a or b.
boolean
C0232741 (UMLS CUI [1,1])
C4050412 (UMLS CUI [1,2])
Informed Consent
Item
ability to give informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Criteria Any Fulfill
Item
patients who meet any one of the following criteria will be excluded from study entry:
boolean
C0243161 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Congenital condition Immune response Unable | Condition Immune response Unable | Therapeutic immunosuppression
Item
any congenital or acquired condition leading to inability to generate an immune response, including concomitant immune suppressive therapy. the ability to adequately respond to recall skin test antigens will be tested before trial entry but a negative response to skin allergens will not be reason for exclusion.
boolean
C3649644 (UMLS CUI [1,1])
C0020964 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0020964 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
C0021079 (UMLS CUI [3])
Steroid therapy | Chemotherapy
Item
concomitant steroid therapy or chemotherapy, or any of these treatments < 30 days before the first vaccination.
boolean
C0149783 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
Childbearing Potential Serum pregnancy test (B-HCG) Negative
Item
females of child-bearing potential (premenopausal and not surgically sterilized) must have a negative serum hcg pregnancy test (within day 14 to day 0).
boolean
C3831118 (UMLS CUI [1,1])
C0430060 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
Communicable Disease | Virus Diseases | Bacterial Infections | Mycoses | Requirement Therapy Specific | Exception Hepatitis B | Exception Hepatitis C | Treatment completed
Item
acute infection: any acute viral, bacterial, or fungal infection, which requires specific therapy excluding hbv or hcv. acute therapy must have been completed within 14 days prior to study treatment.
boolean
C0009450 (UMLS CUI [1])
C0042769 (UMLS CUI [2])
C0004623 (UMLS CUI [3])
C0026946 (UMLS CUI [4])
C1514873 (UMLS CUI [5,1])
C0087111 (UMLS CUI [5,2])
C0205369 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0019163 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C0019196 (UMLS CUI [7,2])
C0580352 (UMLS CUI [8])
HIV Infection
Item
hiv-infected patients (their ability to generate a cellular immune response is altered due to the cd4-dependent immunosuppressive effects of the hiv infection).
boolean
C0019693 (UMLS CUI [1])
Primary disorders Investigational Therapy Contraindicated | Hypersensitivity Reagents
Item
patients with any underlying conditions which would contraindicate therapy with study treatment (or allergies to reagents used in this study).
boolean
C0277554 (UMLS CUI [1,1])
C0949266 (UMLS CUI [1,2])
C1444657 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0034760 (UMLS CUI [2,2])
Organ Allograft
Item
patients with organ allografts (they require prolonged immunosuppressive therapy).
boolean
C0178784 (UMLS CUI [1,1])
C0450127 (UMLS CUI [1,2])
Serum complement titer increased Neutralizing Antibodies Adenoviral
Item
patients with high serum titers of neutralizing anti-adenoviral antibodies (positive at greater than 1:128 dilution by serum adv blocking assay, expected to be approximately 30% of patients, they have a greatly reduced ability to respond to the adv boost).
boolean
C0860571 (UMLS CUI [1,1])
C0475463 (UMLS CUI [1,2])
C0001483 (UMLS CUI [1,3])
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