ID

22573

Descrição

MUC1 Vaccine in Conjunction With Poly-ICLC in Patients With Recurrent and/or Advanced Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00374049

Link

https://clinicaltrials.gov/show/NCT00374049

Palavras-chave

Versões (1)
  1. 08/06/2017 08/06/2017 -
Transferido a

8 de junho de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00374049

Inglês

Eligibility Prostate Cancer NCT00374049

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
18 years of age or older and must have histologically confirmed adenocarcinoma of the prostate with systemic disease are potentially eligible. patients with an early relapse must have undergone and failed definitive surgery and/or radiation. patients can either be hormone naive, may be on concurrent hormone therapy with lhrh analogues, or may be hormone refractory (see section 3.1.4 of the full protocol)
Descrição

Age | Adenocarcinoma of prostate | Systemic disease | Early Relapse | Operative Surgical Procedures failed | Therapeutic radiology procedure failed | Hormone Therapy naive | Hormone Therapy | LHRH Analog | Hormone Therapy Refractory

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0007112
UMLS CUI [3]
C0442893
UMLS CUI [4]
C4055086
UMLS CUI [5,1]
C0543467
UMLS CUI [5,2]
C0231175
UMLS CUI [6,1]
C1522449
UMLS CUI [6,2]
C0231175
UMLS CUI [7,1]
C0279025
UMLS CUI [7,2]
C0919936
UMLS CUI [8]
C0279025
UMLS CUI [9,1]
C0023610
UMLS CUI [9,2]
C0243071
UMLS CUI [10,1]
C0279025
UMLS CUI [10,2]
C0205269
must have evidence of systemic immunosuppression as evidenced by the presence of one or more of the following: 1) low or absent t cell zeta chain expression in peripheral blood (pb), 2) low level cytokine production ( i.e., ifn-gamma , il-4 ) by t cells in pb, 3) upregulation of granulocyte activation markers (cd 15) in pb
Descrição

Immunosuppression Systemic | Peripheral blood T cell zeta chain Expression low | Peripheral blood T cell zeta chain Expression Absent | Peripheral blood T-Lymphocyte Cytokine production low | Interferon Type II | Interleukin-4 | Peripheral blood Granulocyte activation marker Upregulation | CD15

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C4048329
UMLS CUI [1,2]
C0205373
UMLS CUI [2,1]
C0229664
UMLS CUI [2,2]
C0052050
UMLS CUI [2,3]
C0017262
UMLS CUI [2,4]
C0205251
UMLS CUI [3,1]
C0229664
UMLS CUI [3,2]
C0052050
UMLS CUI [3,3]
C0017262
UMLS CUI [3,4]
C0332197
UMLS CUI [4,1]
C0229664
UMLS CUI [4,2]
C0039194
UMLS CUI [4,3]
C1327413
UMLS CUI [4,4]
C0205251
UMLS CUI [5]
C0021745
UMLS CUI [6]
C0021758
UMLS CUI [7,1]
C0229664
UMLS CUI [7,2]
C3549289
UMLS CUI [7,3]
C1611701
UMLS CUI [7,4]
C0041904
UMLS CUI [8]
C0080188
availability of at least 2 psa measurements over 2 to 6 weeks, clearly documenting a rising psa. the minimum rise in psa must be at least 50% from baseline psa. the last of these psa values must be > 2 .
Descrição

Raised prostate specific antigen Prostate specific antigen measurement Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0178415
UMLS CUI [1,2]
C0201544
UMLS CUI [1,3]
C1265611
patients may be hormone-refractory (rising psa, despite castrate testosterone levels, i.e., < 50 ng/ml); may have metastatic disease; and maybe on bisphosphonates. if patients are on anti-androgens (flutamide/casodex), they must have been off of these agents for at least 28 days prior to enrollment for flutamide, and at least 42 days prior to enrollment for bicalutamide (casodex)), without a drop in psa. if hormone refractory, patients will continue lhrh analogues.
Descrição

Hormone Therapy Refractory | Raised prostate specific antigen | Testosterone measurement Castration Level | Neoplasm Metastasis | Diphosphonates | Androgen Antagonists Discontinued | Flutamide Discontinued | Casodex Discontinued | Bicalutamide Discontinued | LHRH Analog

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0205269
UMLS CUI [2]
C0178415
UMLS CUI [3,1]
C0523912
UMLS CUI [3,2]
C0007344
UMLS CUI [3,3]
C0441889
UMLS CUI [4]
C0027627
UMLS CUI [5]
C0012544
UMLS CUI [6,1]
C0002842
UMLS CUI [6,2]
C1444662
UMLS CUI [7,1]
C0016384
UMLS CUI [7,2]
C1444662
UMLS CUI [8,1]
C0591237
UMLS CUI [8,2]
C1444662
UMLS CUI [9,1]
C0285590
UMLS CUI [9,2]
C1444662
UMLS CUI [10,1]
C0023610
UMLS CUI [10,2]
C0243071
signed written informed consent given by the patient before or at enrollment in the study and following receipt of verbal and written information about the study.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
no concomitant therapy with steroids
Descrição

Steroids Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0038317
UMLS CUI [1,2]
C0332197
no other investigational therapy within 4 weeks of enrolling on this protocol
Descrição

Investigational Therapy Additional Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0949266
UMLS CUI [1,2]
C1524062
UMLS CUI [1,3]
C0332197
no chemotherapy or radiation therapy within 6 weeks of enrolling on this protocol.
Descrição

Chemotherapy Absent | Therapeutic radiology procedure Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0332197
ecog performance status 0 or 1
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
patients must have adequate organ and marrow function
Descrição

Organ function | Bone Marrow function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation.
Descrição

Gender Contraceptive methods | Hormonal contraception | Contraception, Barrier

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C2985296
UMLS CUI [3]
C0004764
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who have had chemotherapy or radiation therapy within 6 weeks of study entry.
Descrição

Chemotherapy | Therapeutic radiology procedure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
no concurrent use of other investigational agents.
Descrição

Investigational New Drugs Additional

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C1524062
uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Descrição

Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorder Protocol Compliance Limited | Social situation Protocol Compliance Limited

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0742758
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0003811
UMLS CUI [6,1]
C0004936
UMLS CUI [6,2]
C0525058
UMLS CUI [6,3]
C0439801
UMLS CUI [7,1]
C0748872
UMLS CUI [7,2]
C0525058
UMLS CUI [7,3]
C0439801
presence of an active acute or chronic infection, including urinary tract infection, hiv (as determined by elisa and confirmed by western blot) or viral hepatitis (as determined by hbsag and hepatitis c serology). hiv patients are excluded based on immunosuppression which may render them unable to respond to the vaccine; patients with chronic hepatitis are excluded because of concern that hepatitis could be exacerbated by the injections.
Descrição

Communicable Disease | Chronic infectious disease | Urinary tract infection | HIV Infection Enzyme-Linked Immunosorbent Assay | HIV Infection Western Blot | Viral hepatitis | Hepatitis B surface antigen measurement | Hepatitis C serology test | Immunosuppression | Vaccines Unresponsive to Treatment | Hepatitis, Chronic

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0151317
UMLS CUI [3]
C0042029
UMLS CUI [4,1]
C0019693
UMLS CUI [4,2]
C0014441
UMLS CUI [5,1]
C0019693
UMLS CUI [5,2]
C0949466
UMLS CUI [6,1]
C0042721
UMLS CUI [6,2]
C0201477
UMLS CUI [7,1]
C0042721
UMLS CUI [7,2]
C0850489
UMLS CUI [8]
C4048329
UMLS CUI [9,1]
C0042210
UMLS CUI [9,2]
C0205269
UMLS CUI [10]
C0019189
patients with either previously irradiated or new cns (central nervous system) metastases at entry are excluded. pre-enrollment head ct is not required if not indicated by clinical signs or symptoms.
Descrição

Therapeutic radiology procedure CNS metastases | CNS metastases | CT head Indicated Due to Sign or Symptom

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0686377
UMLS CUI [2]
C0686377
UMLS CUI [3,1]
C0202691
UMLS CUI [3,2]
C1444656
UMLS CUI [3,3]
C0678226
UMLS CUI [3,4]
C3540840
patients with a history of auto-immune disease such as, but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis.
Descrição

Autoimmune Diseases | Inflammatory Bowel Diseases | Lupus Erythematosus, Systemic | Ankylosing spondylitis | Scleroderma | Multiple Sclerosis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2]
C0021390
UMLS CUI [3]
C0024141
UMLS CUI [4]
C0038013
UMLS CUI [5]
C0011644
UMLS CUI [6]
C0026769
subjects with active prior malignancy within the past 5 years (with exception of non-melanoma skin cancers and carcinoma in situ of the bladder).
Descrição

Malignant Neoplasms | Skin carcinoma | Carcinoma in situ of bladder

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0699893
UMLS CUI [3]
C0154091
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Similar models

Eligibility Prostate Cancer NCT00374049

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age | Adenocarcinoma of prostate | Systemic disease | Early Relapse | Operative Surgical Procedures failed | Therapeutic radiology procedure failed | Hormone Therapy naive | Hormone Therapy | LHRH Analog | Hormone Therapy Refractory
Item
18 years of age or older and must have histologically confirmed adenocarcinoma of the prostate with systemic disease are potentially eligible. patients with an early relapse must have undergone and failed definitive surgery and/or radiation. patients can either be hormone naive, may be on concurrent hormone therapy with lhrh analogues, or may be hormone refractory (see section 3.1.4 of the full protocol)
boolean
C0001779 (UMLS CUI [1])
C0007112 (UMLS CUI [2])
C0442893 (UMLS CUI [3])
C4055086 (UMLS CUI [4])
C0543467 (UMLS CUI [5,1])
C0231175 (UMLS CUI [5,2])
C1522449 (UMLS CUI [6,1])
C0231175 (UMLS CUI [6,2])
C0279025 (UMLS CUI [7,1])
C0919936 (UMLS CUI [7,2])
C0279025 (UMLS CUI [8])
C0023610 (UMLS CUI [9,1])
C0243071 (UMLS CUI [9,2])
C0279025 (UMLS CUI [10,1])
C0205269 (UMLS CUI [10,2])
Immunosuppression Systemic | Peripheral blood T cell zeta chain Expression low | Peripheral blood T cell zeta chain Expression Absent | Peripheral blood T-Lymphocyte Cytokine production low | Interferon Type II | Interleukin-4 | Peripheral blood Granulocyte activation marker Upregulation | CD15
Item
must have evidence of systemic immunosuppression as evidenced by the presence of one or more of the following: 1) low or absent t cell zeta chain expression in peripheral blood (pb), 2) low level cytokine production ( i.e., ifn-gamma , il-4 ) by t cells in pb, 3) upregulation of granulocyte activation markers (cd 15) in pb
boolean
C4048329 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0229664 (UMLS CUI [2,1])
C0052050 (UMLS CUI [2,2])
C0017262 (UMLS CUI [2,3])
C0205251 (UMLS CUI [2,4])
C0229664 (UMLS CUI [3,1])
C0052050 (UMLS CUI [3,2])
C0017262 (UMLS CUI [3,3])
C0332197 (UMLS CUI [3,4])
C0229664 (UMLS CUI [4,1])
C0039194 (UMLS CUI [4,2])
C1327413 (UMLS CUI [4,3])
C0205251 (UMLS CUI [4,4])
C0021745 (UMLS CUI [5])
C0021758 (UMLS CUI [6])
C0229664 (UMLS CUI [7,1])
C3549289 (UMLS CUI [7,2])
C1611701 (UMLS CUI [7,3])
C0041904 (UMLS CUI [7,4])
C0080188 (UMLS CUI [8])
Raised prostate specific antigen Prostate specific antigen measurement Quantity
Item
availability of at least 2 psa measurements over 2 to 6 weeks, clearly documenting a rising psa. the minimum rise in psa must be at least 50% from baseline psa. the last of these psa values must be > 2 .
boolean
C0178415 (UMLS CUI [1,1])
C0201544 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Hormone Therapy Refractory | Raised prostate specific antigen | Testosterone measurement Castration Level | Neoplasm Metastasis | Diphosphonates | Androgen Antagonists Discontinued | Flutamide Discontinued | Casodex Discontinued | Bicalutamide Discontinued | LHRH Analog
Item
patients may be hormone-refractory (rising psa, despite castrate testosterone levels, i.e., < 50 ng/ml); may have metastatic disease; and maybe on bisphosphonates. if patients are on anti-androgens (flutamide/casodex), they must have been off of these agents for at least 28 days prior to enrollment for flutamide, and at least 42 days prior to enrollment for bicalutamide (casodex)), without a drop in psa. if hormone refractory, patients will continue lhrh analogues.
boolean
C0279025 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C0178415 (UMLS CUI [2])
C0523912 (UMLS CUI [3,1])
C0007344 (UMLS CUI [3,2])
C0441889 (UMLS CUI [3,3])
C0027627 (UMLS CUI [4])
C0012544 (UMLS CUI [5])
C0002842 (UMLS CUI [6,1])
C1444662 (UMLS CUI [6,2])
C0016384 (UMLS CUI [7,1])
C1444662 (UMLS CUI [7,2])
C0591237 (UMLS CUI [8,1])
C1444662 (UMLS CUI [8,2])
C0285590 (UMLS CUI [9,1])
C1444662 (UMLS CUI [9,2])
C0023610 (UMLS CUI [10,1])
C0243071 (UMLS CUI [10,2])
Informed Consent
Item
signed written informed consent given by the patient before or at enrollment in the study and following receipt of verbal and written information about the study.
boolean
C0021430 (UMLS CUI [1])
Steroids Absent
Item
no concomitant therapy with steroids
boolean
C0038317 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Investigational Therapy Additional Absent
Item
no other investigational therapy within 4 weeks of enrolling on this protocol
boolean
C0949266 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Chemotherapy Absent | Therapeutic radiology procedure Absent
Item
no chemotherapy or radiation therapy within 6 weeks of enrolling on this protocol.
boolean
C0392920 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
ECOG performance status
Item
ecog performance status 0 or 1
boolean
C1520224 (UMLS CUI [1])
Organ function | Bone Marrow function
Item
patients must have adequate organ and marrow function
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Gender Contraceptive methods | Hormonal contraception | Contraception, Barrier
Item
men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation.
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C2985296 (UMLS CUI [2])
C0004764 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Chemotherapy | Therapeutic radiology procedure
Item
patients who have had chemotherapy or radiation therapy within 6 weeks of study entry.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Investigational New Drugs Additional
Item
no concurrent use of other investigational agents.
boolean
C0013230 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorder Protocol Compliance Limited | Social situation Protocol Compliance Limited
Item
uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0004936 (UMLS CUI [6,1])
C0525058 (UMLS CUI [6,2])
C0439801 (UMLS CUI [6,3])
C0748872 (UMLS CUI [7,1])
C0525058 (UMLS CUI [7,2])
C0439801 (UMLS CUI [7,3])
Communicable Disease | Chronic infectious disease | Urinary tract infection | HIV Infection Enzyme-Linked Immunosorbent Assay | HIV Infection Western Blot | Viral hepatitis | Hepatitis B surface antigen measurement | Hepatitis C serology test | Immunosuppression | Vaccines Unresponsive to Treatment | Hepatitis, Chronic
Item
presence of an active acute or chronic infection, including urinary tract infection, hiv (as determined by elisa and confirmed by western blot) or viral hepatitis (as determined by hbsag and hepatitis c serology). hiv patients are excluded based on immunosuppression which may render them unable to respond to the vaccine; patients with chronic hepatitis are excluded because of concern that hepatitis could be exacerbated by the injections.
boolean
C0009450 (UMLS CUI [1])
C0151317 (UMLS CUI [2])
C0042029 (UMLS CUI [3])
C0019693 (UMLS CUI [4,1])
C0014441 (UMLS CUI [4,2])
C0019693 (UMLS CUI [5,1])
C0949466 (UMLS CUI [5,2])
C0042721 (UMLS CUI [6,1])
C0201477 (UMLS CUI [6,2])
C0042721 (UMLS CUI [7,1])
C0850489 (UMLS CUI [7,2])
C4048329 (UMLS CUI [8])
C0042210 (UMLS CUI [9,1])
C0205269 (UMLS CUI [9,2])
C0019189 (UMLS CUI [10])
Therapeutic radiology procedure CNS metastases | CNS metastases | CT head Indicated Due to Sign or Symptom
Item
patients with either previously irradiated or new cns (central nervous system) metastases at entry are excluded. pre-enrollment head ct is not required if not indicated by clinical signs or symptoms.
boolean
C1522449 (UMLS CUI [1,1])
C0686377 (UMLS CUI [1,2])
C0686377 (UMLS CUI [2])
C0202691 (UMLS CUI [3,1])
C1444656 (UMLS CUI [3,2])
C0678226 (UMLS CUI [3,3])
C3540840 (UMLS CUI [3,4])
Autoimmune Diseases | Inflammatory Bowel Diseases | Lupus Erythematosus, Systemic | Ankylosing spondylitis | Scleroderma | Multiple Sclerosis
Item
patients with a history of auto-immune disease such as, but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis.
boolean
C0004364 (UMLS CUI [1])
C0021390 (UMLS CUI [2])
C0024141 (UMLS CUI [3])
C0038013 (UMLS CUI [4])
C0011644 (UMLS CUI [5])
C0026769 (UMLS CUI [6])
Malignant Neoplasms | Skin carcinoma | Carcinoma in situ of bladder
Item
subjects with active prior malignancy within the past 5 years (with exception of non-melanoma skin cancers and carcinoma in situ of the bladder).
boolean
C0006826 (UMLS CUI [1])
C0699893 (UMLS CUI [2])
C0154091 (UMLS CUI [3])
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